Back to resultsEffect of a Protein Intake on Weight Loss of Overweight/Obese Adults (COLABOCO)
Primary Purpose
Obesity, Weight Loss, Protein
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dietary recommendations including protein enriched bars
Dietary recommendations without protein enriched bars
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Protein, Weight loss, Obesity, Overweight, Satiety
Eligibility Criteria
Inclusion Criteria:
- Volunteers with BMI between 24.9 and 34.9 kg/m2.
- Physical examination and vital signs normal or clinically irrelevant to the study.
- Volunteers undergoing pharmacological treatment will be included if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function and antidiabetics.
- Subjects must be able to understand and be willing to sign the informed consent, as well as comply with all the procedures and requirements of the study.
- Present a stable weight (+/-3kg) in the last three months before the start of the study.
Exclusion Criteria:
- Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
- Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
- Women who are breastfeeding or pregnant.
- Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
- Subjects with liver disease.
- Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.
- Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
- Subjects who present some type of cognitive and/or psychic impairment.
- Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
- Subjects who work night shifts.
- Subjects who follow some type of supplementation that interferes with the study.
- Subjects who are immersed in some treatment for weight loss.
Sites / Locations
- Center for Nutrition Research. University of Navarra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group receiving dietary recommendations including protein enriched bars .
Group receiving dietary recommendations without protein enriched bars.
Arm Description
Experimental group will consume two protein enriched bars per day during 12 weeks. First bar will be consumed 45 minutes before lunch and second bar will be consumed 45 minutes before dinner.
Placebo group will follow just dietary recommendations during 12 weeks.
Outcomes
Primary Outcome Measures
Change of weight from baseline to week 4 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from baseline to week 8 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from baseline to week 12 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from week 4 to week 8 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from week 4 to week 12 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from week 8 to week 12 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Secondary Outcome Measures
Change of body fat percentage from baseline to week 8 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Change of body fat percentage from baseline to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Change of body fat percentage from week 8 to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Change of body fat kilograms from baseline to week 8 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body fat kilograms from baseline to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body fat kilograms from week 8 to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body muscle mass from baseline to week 8 (bioimpedance)
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body muscle mass from baseline to week 12 (bioimpedance)
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body muscle mass from week 8 to week 12 (bioimpedance)
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body lean mass from baseline to week 8 (bioimpedance)
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body lean mass from baseline to week 12 (bioimpedance)
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body lean mass from week 8 to week 12 (bioimpedance)
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body water mass from baseline to week 8 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body water mass from baseline to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body water mass from week 8 to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of body water percentage from baseline to week 8 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Change of body water percentage from baseline to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Change of body water percentage from week 8 to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Change of bone mass from baseline to week 8 (bioimpedance)
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of bone mass from baseline to week 12 (bioimpedance)
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Change of bone mass from week 8 to week 12 (bioimpedance)
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Height at baseline
Height of participants will be measured by stadiometer and reported in meters.
Change of waist circumference from baseline to week 8
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Change of waist circumference from baseline to week 12
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Change of waist circumference from week 8 to week 12
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Change of hip circumference from baseline to week 8
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Change of hip circumference from baseline to week 12
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Change of hip circumference from week 8 to week 12
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Change of neck circumference from baseline to week 8
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Change of neck circumference from baseline to week 12
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Change of neck circumference from week 8 to week 12
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Change of systolic blood pressure from baseline to week 4
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of systolic blood pressure from baseline to week 8
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of systolic blood pressure from baseline to week 12
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of systolic blood pressure from week 4 to week 8
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of systolic blood pressure from week 8 to week 12
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of diastolic blood pressure from baseline to week 4
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of diastolic blood pressure from baseline to week 8
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of diastolic blood pressure from baseline to week 12
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of diastolic blood pressure from week 4 to week 8
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of diastolic blood pressure from week 8 to week 12
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Change of heart rate from baseline to week 4
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Change of heart rate from baseline to week 8
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Change of heart rate from baseline to week 12
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Change of heart rate from week 4 to week 8
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Change of heart rate from week 8 to week 12
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Change of body fat mass in percentage from baseline to week 8 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Change of body fat mass in percentage from baseline to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Change of body fat mass in percentage from week 8 to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Change of body fat mass in kg from baseline to week 8 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of body fat mass in kg from baseline to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of body fat mass in kg from week 8 to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of lean mass in kg from baseline to week 8 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of lean mass in kg from baseline to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of lean mass in kg from week 8 to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of lean mass in kg from baseline to week 12 (densitometry)
Change of lean mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of bone mineral concentration from baseline to week 8 (densitometry)
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of bone mineral concentration from baseline to week 12 (densitometry)
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of bone mineral concentration from week 8 to week 12 (densitometry)
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of bone mineral density from baseline to week 8 (densitometry)
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of bone mineral density from baseline to week 12 (densitometry)
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of bone mineral density from week 8 to week 12 (densitometry)
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of visceral mass from baseline to week 8 (densitometry)
Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of visceral mass from baseline to week 12 (densitometry)
Change of visceral mass density of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of visceral mass from week 8 to week 12 (densitometry)
Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Change of L1-L4 bone mineral density from baseline to week 8 (densitometry)
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of L1-L4 bone mineral density from baseline to week 12 (densitometry)
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of L1-L4 bone mineral density from week 8 to week 12 (densitometry)
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of total bone mineral density of femur from baseline to week 8 (densitometry)
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of total bone mineral density of femur from baseline to week 12 (densitometry)
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of total bone mineral density of femur from week 8 to week 12 (densitometry)
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of bone mineral density of femur neck from baseline to week 8 (densitometry)
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of bone mineral density of femur neck from baseline to week 12 (densitometry)
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of bone mineral density of femur neck from week 8 to week 12 (densitometry)
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of bone mineral density of radius from baseline to week 8 (densitometry)
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of bone mineral density of radius from baseline to week 12 (densitometry)
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of bone mineral density of radius from week 8 to week 12 (densitometry)
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Change of glucose concentration from baseline to week 8
Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of glucose concentration from baseline to week 12
Change of glucose levels of participants in fasting condition will be analyzed by absorptiometry and reported in mg/dL.
Change of glucose concentration from week 8 to week 12
Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of total cholesterol concentration from baseline to week 8
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of total cholesterol concentration from baseline to week 12
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of total cholesterol concentration from week 8 to week 12
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of HDL cholesterol concentration from baseline to week 8
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of HDL cholesterol concentration from baseline to week 12
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of HDL cholesterol concentration from week 8 to week 12
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of LDL cholesterol concentration from baseline to week 8
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Change of LDL cholesterol concentration from baseline to week 12
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Change of LDL cholesterol concentration from week 8 to week 12
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Change of triglyceride concentration from baseline to week 8
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of triglyceride concentration from baseline to week 12
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of triglyceride concentration from week 8 to week 12
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of alanine aminotransferase concentration from baseline to week 8
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Change of alanine aminotransferase concentration from baseline to week 12
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Change of alanine aminotransferase concentration from week 8 to week 12
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Change of aspartate aminotransferase concentration from baseline to week 8
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Change of aspartate aminotransferase concentration from baseline to week 12
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Change of aspartate aminotransferase concentration from week 8 to week 12
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Change of homocysteine concentration from baseline to week 8
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L.
Change of homocysteine concentration from baseline to week 12
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..
Change of homocysteine concentration from week 8 to week 12
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..
Change of C-reactive protein concentration from baseline to week 8
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Change of C-reactive protein concentration from baseline to week 12
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Change of C-reactive protein concentration from week 8 to week 12
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Change of hemogram concentration from baseline to week 8
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Change of hemogram concentration from baseline to week 12
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Change of hemogram concentration from week 8 to week 12
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Change of albumin concentration from baseline to week 8
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Change of albumin concentration from baseline to week 12
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Change of albumin concentration from week 8 to week 12
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Change of creatinine concentration from baseline to week 8
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Change of creatinine concentration from baseline to week 12
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Change of creatinine concentration from week 8 to week 12
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Change of physical activity level from baseline to week 8
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Change of physical activity level from baseline to week 12
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Change of physical activity level from week 8 to week 12
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Change of dietary intake from baseline to week 8
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Change of dietary intake from baseline to week 12
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Change of dietary intake from week 8 to week 12
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Change of hunger from baseline to week 4
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Change of hunger from baseline to week 8
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Change of hunger from baseline to week 12
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Change of hunger from week 4 to week 8
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Change of hunger from week 8 to week 12
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Change of fullness from baseline to week 4
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Change of fullness from baseline to week 8
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Change of fullness from baseline to week 12
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Change of fullness from week 4 to week 8
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Change of fullness from week 8 to week 12
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Change of satisfaction sensation from baseline to week 4
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Change of satisfaction sensation from baseline to week 8
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Change of satisfaction sensation from baseline to week 12
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Change of satisfaction sensation from week 4 to week 8
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Change of satisfaction sensation from week 8 to week 12
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Change of want to eat something else sensation from baseline to week 4
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Change of want to eat something else sensation from baseline to week 8
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Change of want to eat something else sensation from baseline to week 12
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Change of want to eat something else sensation from week 4 to week 8
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Change of want to eat something else sensation from week 8 to week 12
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Change of thirst sensation from baseline to week 4
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Change of thirst sensation from baseline to week 8
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Change of thirst sensation from baseline to week 12
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Change of thirst sensation from week 4 to week 8
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Change of thirst sensation from week 8 to week 12
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Change of gastrointestinal symptoms from baseline to week 4
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Change of gastrointestinal symptoms from baseline to week 8
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Change of gastrointestinal symptoms from baseline to week 12
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Change of gastrointestinal symptoms from week 4 to week 8
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Change of gastrointestinal symptoms from week 8 to week 12
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Bar acceptance at week 12
Bar acceptance will be analyzed by acceptance questionnaire.
Change of bar consumption record from baseline to week 4
Change of bar consumption will be analyzed by bar consumption record.
Change of bar consumption record from baseline to week 8
Change of bar consumption will be analyzed by bar consumption record.
Change of bar consumption record from baseline to week 12
Change of bar consumption will be analyzed by bar consumption record.
Change of bar consumption record from week 4 to week 8
Change of bar consumption will be analyzed by bar consumption record.
Change of bar consumption record from week 8 to week 12
Change of bar consumption will be analyzed by bar consumption record.
Change in urine and feces hydroxyproline concentration from baseline to week 8
Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8
Change in urine and feces hydroxyproline concentration from baseline to week 12
Change of hydroxyproline concentration will be analyzed by colorimetry technique
Change in urine and feces hydroxyproline concentration from week 8 to week 12
Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8
Full Information
NCT ID
NCT05368311
First Posted
March 3, 2022
Last Updated
May 11, 2023
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
1. Study Identification
Unique Protocol Identification Number
NCT05368311
Brief Title
Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults
Acronym
COLABOCO
Official Title
Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
June 24, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obesity is considered the epidemic of the 21st century. Obesity is a multifactorial disease and the most important risk factors are poor diet and sedentary lifestyle. An excessive body weight contributes to increase the risk of suffering from other diseases and mortality rates. Therefore, the prevention and control of excessive body weight as well as its comorbidities are essential. In this sense, the principal strategy to treat obesity is to improve dietary habits and increase physical activity. However, the rate of obesity continues rising. In order to deal with this problem, new strategies to combat obesity are being investigated, such as the investigation of new bioactive compounds with satiating capacity that can be included in healthy dietary patterns to improve adherence to dietary treatments.
Considering this background, the main objective of this research is to assess the effect of daily consumption of protein rich bars accompanied by healthy dietary recommendations on weight loss of overweight/obese adult men and women.
Detailed Description
This study is designed as a 12-week, randomised, parallel study, focused on overweight/obese men and women between 20 and 65 years old.
All participants attend the Nutrition Intervention Unit of the Center for Nutrition Research in the University of Navarra for the screening visit and 4 more times during the intervention (week 1, 4, 8 and 12 of study).
Screening visit: evaluation of the inclusion criteria. Volunteers who meet the inclusion criteria are provided with a feces collection kit, urine collection kit, food frequency questionnaire, visual analogue scale and minnesota physical activity questionnaire. Moreover, they are randomly assigned to one of the two intervention groups:
Control group: healthy dietary recommendations.
Experimental group: healthy dietary recommendations + 2 protein rich bars/day
Clinical investigation day 1 (week 1): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in screening visit. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. After that, volunteer is provided with healthy dietary recommendations only or dietary recommendations and protein rich bars, depending on the allocated intervention group. Moreover, volunteer is provided with visual analogue scale to be completed for the Clinical investigation day 2.
Clinical investigation day 2 (week 4): The volunteer attend the Nutrition Intervention Unit. The volunteer is asked to provide the visual analogue scale. Then, gastrointestinal symptoms questionnaire is completed and the adherence to the study is assessed. Then, body weight and blood pressure are measured. Volunteer is provided with fece and urine collection kits, food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale, to be completed for the Clinical investigation day 3. Finally, volunteers allocated in experimental group are provided with protein rich bars.
Clinical investigation day 3 (week 8): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 2. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. Volunteer is provided with fece and urine collection kits, as well as food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale to be completed for the Clinical investigation day 4. Finally, volunteers allocated in experimental group are provided with protein rich bars.
Clinical investigation day 4 (week 12): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 3. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Protein
Keywords
Protein, Weight loss, Obesity, Overweight, Satiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group receiving dietary recommendations including protein enriched bars .
Arm Type
Experimental
Arm Description
Experimental group will consume two protein enriched bars per day during 12 weeks. First bar will be consumed 45 minutes before lunch and second bar will be consumed 45 minutes before dinner.
Arm Title
Group receiving dietary recommendations without protein enriched bars.
Arm Type
Placebo Comparator
Arm Description
Placebo group will follow just dietary recommendations during 12 weeks.
Intervention Type
Other
Intervention Name(s)
Dietary recommendations including protein enriched bars
Intervention Description
Volunteers allocated in the experimental group will receive dietary recommendations and 2 protein enriched bars per day to be eaten 45 minutes before lunch and dinner.
Intervention Type
Other
Intervention Name(s)
Dietary recommendations without protein enriched bars
Intervention Description
Volunteers allocated in the experimental group will receive dietary recommendations.
Primary Outcome Measure Information:
Title
Change of weight from baseline to week 4 (bioimpedance)
Description
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of weight from baseline to week 8 (bioimpedance)
Description
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of weight from baseline to week 12 (bioimpedance)
Description
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of weight from week 4 to week 8 (bioimpedance)
Description
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 3(after 8 weeks of intervention).
Title
Change of weight from week 4 to week 12 (bioimpedance)
Description
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of weight from week 8 to week 12 (bioimpedance)
Description
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Secondary Outcome Measure Information:
Title
Change of body fat percentage from baseline to week 8 (bioimpedance)
Description
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of body fat percentage from baseline to week 12 (bioimpedance)
Description
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body fat percentage from week 8 to week 12 (bioimpedance)
Description
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body fat kilograms from baseline to week 8 (bioimpedance)
Description
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of body fat kilograms from baseline to week 12 (bioimpedance)
Description
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body fat kilograms from week 8 to week 12 (bioimpedance)
Description
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body muscle mass from baseline to week 8 (bioimpedance)
Description
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of body muscle mass from baseline to week 12 (bioimpedance)
Description
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body muscle mass from week 8 to week 12 (bioimpedance)
Description
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body lean mass from baseline to week 8 (bioimpedance)
Description
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of body lean mass from baseline to week 12 (bioimpedance)
Description
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body lean mass from week 8 to week 12 (bioimpedance)
Description
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body water mass from baseline to week 8 (bioimpedance)
Description
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of body water mass from baseline to week 12 (bioimpedance)
Description
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body water mass from week 8 to week 12 (bioimpedance)
Description
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body water percentage from baseline to week 8 (bioimpedance)
Description
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of body water percentage from baseline to week 12 (bioimpedance)
Description
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body water percentage from week 8 to week 12 (bioimpedance)
Description
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mass from baseline to week 8 (bioimpedance)
Description
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of bone mass from baseline to week 12 (bioimpedance)
Description
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mass from week 8 to week 12 (bioimpedance)
Description
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Height at baseline
Description
Height of participants will be measured by stadiometer and reported in meters.
Time Frame
The Time Frame contains one time point: screening visit.
Title
Change of waist circumference from baseline to week 8
Description
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of waist circumference from baseline to week 12
Description
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of waist circumference from week 8 to week 12
Description
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of hip circumference from baseline to week 8
Description
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of hip circumference from baseline to week 12
Description
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of hip circumference from week 8 to week 12
Description
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of neck circumference from baseline to week 8
Description
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of neck circumference from baseline to week 12
Description
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of neck circumference from week 8 to week 12
Description
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of systolic blood pressure from baseline to week 4
Description
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of systolic blood pressure from baseline to week 8
Description
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of systolic blood pressure from baseline to week 12
Description
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of systolic blood pressure from week 4 to week 8
Description
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of systolic blood pressure from week 8 to week 12
Description
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of diastolic blood pressure from baseline to week 4
Description
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of diastolic blood pressure from baseline to week 8
Description
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of diastolic blood pressure from baseline to week 12
Description
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of diastolic blood pressure from week 4 to week 8
Description
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of diastolic blood pressure from week 8 to week 12
Description
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of heart rate from baseline to week 4
Description
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of heart rate from baseline to week 8
Description
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of heart rate from baseline to week 12
Description
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of heart rate from week 4 to week 8
Description
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of heart rate from week 8 to week 12
Description
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body fat mass in percentage from baseline to week 8 (densitometry)
Description
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of body fat mass in percentage from baseline to week 12 (densitometry)
Description
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body fat mass in percentage from week 8 to week 12 (densitometry)
Description
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body fat mass in kg from baseline to week 8 (densitometry)
Description
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of body fat mass in kg from baseline to week 12 (densitometry)
Description
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of body fat mass in kg from week 8 to week 12 (densitometry)
Description
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of lean mass in kg from baseline to week 8 (densitometry)
Description
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of lean mass in kg from baseline to week 12 (densitometry)
Description
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of lean mass in kg from week 8 to week 12 (densitometry)
Description
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of lean mass in kg from baseline to week 12 (densitometry)
Description
Change of lean mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mineral concentration from baseline to week 8 (densitometry)
Description
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of bone mineral concentration from baseline to week 12 (densitometry)
Description
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mineral concentration from week 8 to week 12 (densitometry)
Description
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mineral density from baseline to week 8 (densitometry)
Description
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of bone mineral density from baseline to week 12 (densitometry)
Description
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mineral density from week 8 to week 12 (densitometry)
Description
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of visceral mass from baseline to week 8 (densitometry)
Description
Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of visceral mass from baseline to week 12 (densitometry)
Description
Change of visceral mass density of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of visceral mass from week 8 to week 12 (densitometry)
Description
Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of L1-L4 bone mineral density from baseline to week 8 (densitometry)
Description
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of L1-L4 bone mineral density from baseline to week 12 (densitometry)
Description
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of L1-L4 bone mineral density from week 8 to week 12 (densitometry)
Description
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of total bone mineral density of femur from baseline to week 8 (densitometry)
Description
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of total bone mineral density of femur from baseline to week 12 (densitometry)
Description
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of total bone mineral density of femur from week 8 to week 12 (densitometry)
Description
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mineral density of femur neck from baseline to week 8 (densitometry)
Description
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of bone mineral density of femur neck from baseline to week 12 (densitometry)
Description
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mineral density of femur neck from week 8 to week 12 (densitometry)
Description
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mineral density of radius from baseline to week 8 (densitometry)
Description
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of bone mineral density of radius from baseline to week 12 (densitometry)
Description
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bone mineral density of radius from week 8 to week 12 (densitometry)
Description
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of glucose concentration from baseline to week 8
Description
Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of glucose concentration from baseline to week 12
Description
Change of glucose levels of participants in fasting condition will be analyzed by absorptiometry and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of glucose concentration from week 8 to week 12
Description
Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of total cholesterol concentration from baseline to week 8
Description
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of total cholesterol concentration from baseline to week 12
Description
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of total cholesterol concentration from week 8 to week 12
Description
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of HDL cholesterol concentration from baseline to week 8
Description
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of HDL cholesterol concentration from baseline to week 12
Description
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of HDL cholesterol concentration from week 8 to week 12
Description
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of LDL cholesterol concentration from baseline to week 8
Description
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of LDL cholesterol concentration from baseline to week 12
Description
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of LDL cholesterol concentration from week 8 to week 12
Description
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of triglyceride concentration from baseline to week 8
Description
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of triglyceride concentration from baseline to week 12
Description
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of triglyceride concentration from week 8 to week 12
Description
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of alanine aminotransferase concentration from baseline to week 8
Description
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of alanine aminotransferase concentration from baseline to week 12
Description
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of alanine aminotransferase concentration from week 8 to week 12
Description
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of aspartate aminotransferase concentration from baseline to week 8
Description
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of aspartate aminotransferase concentration from baseline to week 12
Description
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of aspartate aminotransferase concentration from week 8 to week 12
Description
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of homocysteine concentration from baseline to week 8
Description
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of homocysteine concentration from baseline to week 12
Description
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of homocysteine concentration from week 8 to week 12
Description
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of C-reactive protein concentration from baseline to week 8
Description
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of C-reactive protein concentration from baseline to week 12
Description
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of C-reactive protein concentration from week 8 to week 12
Description
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of hemogram concentration from baseline to week 8
Description
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of hemogram concentration from baseline to week 12
Description
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of hemogram concentration from week 8 to week 12
Description
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of albumin concentration from baseline to week 8
Description
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of albumin concentration from baseline to week 12
Description
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of albumin concentration from week 8 to week 12
Description
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of creatinine concentration from baseline to week 8
Description
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 8 weeks of intervention).
Title
Change of creatinine concentration from baseline to week 12
Description
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of creatinine concentration from week 8 to week 12
Description
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of physical activity level from baseline to week 8
Description
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of physical activity level from baseline to week 12
Description
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of physical activity level from week 8 to week 12
Description
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of dietary intake from baseline to week 8
Description
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of dietary intake from baseline to week 12
Description
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of dietary intake from week 8 to week 12
Description
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of hunger from baseline to week 4
Description
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of hunger from baseline to week 8
Description
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of hunger from baseline to week 12
Description
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of hunger from week 4 to week 8
Description
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of hunger from week 8 to week 12
Description
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of fullness from baseline to week 4
Description
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of fullness from baseline to week 8
Description
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of fullness from baseline to week 12
Description
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of fullness from week 4 to week 8
Description
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of fullness from week 8 to week 12
Description
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of satisfaction sensation from baseline to week 4
Description
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of satisfaction sensation from baseline to week 8
Description
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of satisfaction sensation from baseline to week 12
Description
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of satisfaction sensation from week 4 to week 8
Description
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of satisfaction sensation from week 8 to week 12
Description
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of want to eat something else sensation from baseline to week 4
Description
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of want to eat something else sensation from baseline to week 8
Description
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of want to eat something else sensation from baseline to week 12
Description
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of want to eat something else sensation from week 4 to week 8
Description
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of want to eat something else sensation from week 8 to week 12
Description
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of thirst sensation from baseline to week 4
Description
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of thirst sensation from baseline to week 8
Description
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of thirst sensation from baseline to week 12
Description
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of thirst sensation from week 4 to week 8
Description
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of thirst sensation from week 8 to week 12
Description
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of gastrointestinal symptoms from baseline to week 4
Description
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of gastrointestinal symptoms from baseline to week 8
Description
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of gastrointestinal symptoms from baseline to week 12
Description
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of gastrointestinal symptoms from week 4 to week 8
Description
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of gastrointestinal symptoms from week 8 to week 12
Description
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time Frame
The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Bar acceptance at week 12
Description
Bar acceptance will be analyzed by acceptance questionnaire.
Time Frame
The Time Frame contains Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bar consumption record from baseline to week 4
Description
Change of bar consumption will be analyzed by bar consumption record.
Time Frame
The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Title
Change of bar consumption record from baseline to week 8
Description
Change of bar consumption will be analyzed by bar consumption record.
Time Frame
The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of bar consumption record from baseline to week 12
Description
Change of bar consumption will be analyzed by bar consumption record.
Time Frame
The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change of bar consumption record from week 4 to week 8
Description
Change of bar consumption will be analyzed by bar consumption record.
Time Frame
The Time Frame contains Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change of bar consumption record from week 8 to week 12
Description
Change of bar consumption will be analyzed by bar consumption record.
Time Frame
The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change in urine and feces hydroxyproline concentration from baseline to week 8
Description
Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8
Time Frame
The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Title
Change in urine and feces hydroxyproline concentration from baseline to week 12
Description
Change of hydroxyproline concentration will be analyzed by colorimetry technique
Time Frame
The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Title
Change in urine and feces hydroxyproline concentration from week 8 to week 12
Description
Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8
Time Frame
The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Balanced in men and women.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Volunteers with BMI between 24.9 and 34.9 kg/m2.
Physical examination and vital signs normal or clinically irrelevant to the study.
Volunteers undergoing pharmacological treatment will be included if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function and antidiabetics.
Subjects must be able to understand and be willing to sign the informed consent, as well as comply with all the procedures and requirements of the study.
Present a stable weight (+/-3kg) in the last three months before the start of the study.
Exclusion Criteria:
Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
Women who are breastfeeding or pregnant.
Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
Subjects with liver disease.
Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.
Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
Subjects who present some type of cognitive and/or psychic impairment.
Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
Subjects who work night shifts.
Subjects who follow some type of supplementation that interferes with the study.
Subjects who are immersed in some treatment for weight loss.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Ángeles Zulet, Professor
Organizational Affiliation
Center for Nutrition Research, University of Navarra.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos J González Navarro, PhD
Organizational Affiliation
Center for Nutrition Research, University of Navarra.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fermín I Milagro Yoldi, PhD
Organizational Affiliation
Center for Nutrition Research, University of Navarra.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Idoia Ibero Baraibar, PhD
Organizational Affiliation
Center for Nutrition Research, University of Navarra.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Itziar Abete Goñi, PhD
Organizational Affiliation
Center for Nutrition Research, University of Navarra.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Miguel López Yoldi, PhD
Organizational Affiliation
Center for Nutrition Research, University of Navarra.
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Nutrition Research. University of Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults
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