Back to resultsEnriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia (SACIMIEL)
Primary Purpose
Overweight and Obesity, Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control honey
Modified honey with soluble fiber and polyphenols
Sponsored by
About this trial
This is an interventional other trial for Overweight and Obesity focused on measuring Saciety, Honey, Fiber, Polyphenols, Visual Analogue Scale, Cross-over, Parallel
Eligibility Criteria
Inclusion Criteria:
- Men and women from 18 to 65 years old.
- Body Mass Index (BMI) ≥25 and <40 kg/m2.
- Cardiovascular risk <10% to 10 years measured by REGICOR.
Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:
- ≥ 45 years or women ≥ 55 years.
- Family history of cardiovascular disease (CVD) in first degree male relative less than 55 years of age and less than 65 years in women.
- HDL cholesterol: men <40 or women <50.
- Triglycerides ≥ 150mg/dL and <200 mg/dL
- LDL cholesterol ≥ 130mg/dL and < 160mg/dL
- Smoker
- Willingness to follow a healthy and balanced hypocaloric diet with mandatory physical activity
- Social or familiar environment that prevents from accomplishing the dietary treatment
- Adequate cultural level and understanding for the clinical trial.
- Signed informed consent
Exclusion Criteria:
- Body Mass Index (BMI) <25 and ≥40 kg/m2.
- Individuals diagnosed with Diabetes Mellitus type 1 or 2.
- Individuals with dyslipidemia on pharmacological treatment.
- Individuals with hypertension on pharmacological treatment.
- Individuals diagnosed with eating disorders.
- Individuals fructose-intolerant.
- Individuals with a diagnosis of celiac disease or a gluten intolerance.
- Individuals with severe chronic diseases (hepatic, kidney, …)
- Individuals receiving a pharmacological treatment that modifies the lipid or glucose profile.
- Individuals who have participated in the last 3 months in a program or clinical trial to lose weight.
- Individuals with mental illness.
- Smokers wanting to stop to smoke during the period that clinical trial lasts.
- Individuals with high alcohol consumption (> 2-3 servings/ day in men and> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer).
- Individuals with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet.
- Individuals with sensory problems.
- Individuals with gastrointestinal diseases that affect the digestion or absorption of nutrients.
- Individuals under pharmacological treatment for losing weight unless treatment is suspended 30 days before the start of the trial.
- Subjects with intense physical activity.
- Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
- Pregnant or breastfeeding women.
Sites / Locations
- Institute for Health Research IdiPAZ
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control honey
Modified honey with soluble fiber and polyphenols
Arm Description
Orange blossom honey. Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day. Short term trial: 20g/day in a single day.
Honey modified with soluble fiber and polyphenols Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day. Short term trial: 20g/day in a single day.
Outcomes
Primary Outcome Measures
Change from Baseline Satiety Hunger Assessment
Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line.
e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.
Secondary Outcome Measures
Change from Baseline Lipid Metabolism Parameters
Cholesterol, LDL-C, HDL-C, TG
Amount of food consumed in a "food ad libitum"
120 min After eating the study product
Total amount of food consumed in 24h
24h Food Record Method
Change from Baseline Glucose Metabolism Parameters
Glucose
Anthropometric Parameters
Weight and height will be combined to report BMI in kg/m2
Sensory Perception Test
Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness.
Adverse Effects
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Full Information
NCT ID
NCT04153617
First Posted
September 12, 2019
Last Updated
November 5, 2019
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Primo Mendoza S.L.
1. Study Identification
Unique Protocol Identification Number
NCT04153617
Brief Title
Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia
Acronym
SACIMIEL
Official Title
Nutritional and Clinical Trial to Evaluate the Effect of a Modified Honey With Soluble Fiber and Polyphenols Consumption in Subjects With Overweight/Obesity and Dyslipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Primo Mendoza S.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this trial is to evaluate the possible benefits on saciety and dyslipidemia in subjects with overweight/obesity (BMI ≥25 y <40 kg / m2) and dyslipemia after consumption of a modifed honey with soluble fiber and polyphenols.
Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk. Besides, polyphenols have reported with their potent antioxidant effect and their implication lowering the vardiovascular risk.
Detailed Description
The trial was designed as a randomized, parallel, double-blind and controlled study with 2 experimental arms. This study was performed to evaluate the effect on saciety and dyslipidemia of subjects with overweight/obesity after a long consumption (3 months) of a modified honey with soluble fiber and polyphenols. Additionally, a short-term randomized, cross-over, doble-blind and controlled trial was also performed to evaluate immediate saciety effect on the same subjects.
For the middle-term study, investigators included 67 participants (8 men and 59 women) between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into 2 study groups, and participants received the 2 different study products during the 3 months. On the other hand, the associated short-term trial included 10 participants (5 men and 5 women) between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into 2 study groups, and participants took the 2 different study products in two non-consecutive days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Dyslipidemias
Keywords
Saciety, Honey, Fiber, Polyphenols, Visual Analogue Scale, Cross-over, Parallel
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control honey
Arm Type
Placebo Comparator
Arm Description
Orange blossom honey.
Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day.
Short term trial: 20g/day in a single day.
Arm Title
Modified honey with soluble fiber and polyphenols
Arm Type
Experimental
Arm Description
Honey modified with soluble fiber and polyphenols
Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day.
Short term trial: 20g/day in a single day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control honey
Intervention Description
Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Modified honey with soluble fiber and polyphenols
Intervention Description
Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day)
Primary Outcome Measure Information:
Title
Change from Baseline Satiety Hunger Assessment
Description
Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line.
e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.
Time Frame
Day 1, 2
Secondary Outcome Measure Information:
Title
Change from Baseline Lipid Metabolism Parameters
Description
Cholesterol, LDL-C, HDL-C, TG
Time Frame
Week 1,12
Title
Amount of food consumed in a "food ad libitum"
Description
120 min After eating the study product
Time Frame
Day 1, 2
Title
Total amount of food consumed in 24h
Description
24h Food Record Method
Time Frame
Day 1, 2; Week 1, 6, 12
Title
Change from Baseline Glucose Metabolism Parameters
Description
Glucose
Time Frame
Day 1, 2; Week 1, 12
Title
Anthropometric Parameters
Description
Weight and height will be combined to report BMI in kg/m2
Time Frame
Day 1, 2; Week 1, 12
Title
Sensory Perception Test
Description
Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness.
Time Frame
Day 1, 2; Week 6, 12
Title
Adverse Effects
Description
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Time Frame
Day 1, 2; Week 6, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women from 18 to 65 years old.
Body Mass Index (BMI) ≥25 and <40 kg/m2.
Cardiovascular risk <10% to 10 years measured by REGICOR.
Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:
≥ 45 years or women ≥ 55 years.
Family history of cardiovascular disease (CVD) in first degree male relative less than 55 years of age and less than 65 years in women.
HDL cholesterol: men <40 or women <50.
Triglycerides ≥ 150mg/dL and <200 mg/dL
LDL cholesterol ≥ 130mg/dL and < 160mg/dL
Smoker
Willingness to follow a healthy and balanced hypocaloric diet with mandatory physical activity
Social or familiar environment that prevents from accomplishing the dietary treatment
Adequate cultural level and understanding for the clinical trial.
Signed informed consent
Exclusion Criteria:
Body Mass Index (BMI) <25 and ≥40 kg/m2.
Individuals diagnosed with Diabetes Mellitus type 1 or 2.
Individuals with dyslipidemia on pharmacological treatment.
Individuals with hypertension on pharmacological treatment.
Individuals diagnosed with eating disorders.
Individuals fructose-intolerant.
Individuals with a diagnosis of celiac disease or a gluten intolerance.
Individuals with severe chronic diseases (hepatic, kidney, …)
Individuals receiving a pharmacological treatment that modifies the lipid or glucose profile.
Individuals who have participated in the last 3 months in a program or clinical trial to lose weight.
Individuals with mental illness.
Smokers wanting to stop to smoke during the period that clinical trial lasts.
Individuals with high alcohol consumption (> 2-3 servings/ day in men and> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer).
Individuals with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet.
Individuals with sensory problems.
Individuals with gastrointestinal diseases that affect the digestion or absorption of nutrients.
Individuals under pharmacological treatment for losing weight unless treatment is suspended 30 days before the start of the trial.
Subjects with intense physical activity.
Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
Pregnant or breastfeeding women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, MD, Phd
Organizational Affiliation
La Paz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health Research IdiPAZ
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia
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