Back to resultsThe Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
Primary Purpose
Overweight and Obesity, Metabolic Syndrome, Hyperuricemia
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
low fructose
Normal fructose arm
Sponsored by
About this trial
This is an interventional screening trial for Overweight and Obesity focused on measuring Role of Fructose in overweight and obesity, Fructose and metabolic syndrome, Low fructose diet study, Effects of fructose in blood pressure and hypertension, Somatometry changes observed in fructose diets, Fructose induced overweight and obesity, Fructose induced metabolic syndrome, Fructose induced hyperuricemia
Eligibility Criteria
Inclusion Criteria:
- Individuals with a Body Mass Index (BMI) > 25. BMI defined as: Weight in kilograms divided by Height (squared) in meters.
- Residents of Mexico city
- Healthy individuals (no comorbidities or drug prescription for associated chronic diseases)
Exclusion Criteria:
- Diabetes Mellitus Type 1 or 2
- Severe Hypertension (defined as systolic blood pressure > 160 mmHg and /or diastolic blood pressure > 100 mmHg) and/or Hypertension on pharmacological treatment.
- Chronic Kidney Disease (Glomerular Filtration Rate (GFR) < 60 ml/min)
- Hepatic Damage or Advanced Disease (clinical, biochemical or histological)
- Patient receiving any pharmacological treatments for hypercholesterolemia and/or elevated triglycerides.
- Anemia (any etiology)
- Malignancy
- Pregnancy
Sites / Locations
- Instituto Nacional de Cardiología Igancio Chávez
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low fructose arm
Normal fructose arm
Arm Description
Overweighted or obese previously healthy adults (with no other comorbidities, defined as: Diabetes (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of >25 kilograms(weight)/ squared meters (height). They will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and rest energy (without exercise). This group will be assigned to a 2 week period of low fructose diet (less than 10 grams/day ) followed by a 4 week period of less than 20 grams/day fructose diet levels. Total Time of intervention 6 weeks for each patient
Overweighted or obese previously healthy adults (with no other comorbidities; defined as: Diabetes Mellitus (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of >25 kilograms(weight)/ squared meters (height). Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet (of 15% proteins, 30% lipids and 55% carbohydrates); calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). This group will receive a controlled fructose diet between 50 and 70 grams/day of fructose intake. Total time of intervention:6 weeks for each patient
Outcomes
Primary Outcome Measures
Somatometry: including weight, height, Body Mass Index (BMI), % Body fat levels, waist and hip index, and blood pressure levels measurements performed by a single evaluator and calibrated equipment
measurements will be performed by a trained evaluator
Secondary Outcome Measures
Blood samples: to evaluate metabolic syndrome parameters
samples will be obtained after an eight fasting period
Full Information
NCT ID
NCT00868673
First Posted
March 24, 2009
Last Updated
July 8, 2010
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
1. Study Identification
Unique Protocol Identification Number
NCT00868673
Brief Title
The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
Official Title
The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if a low fructose intake could have an impact on weight loss, uric acid levels and the components of the metabolic syndrome (glucose, cholesterol, triglycerides, insulin resistance, high blood pressure).
Detailed Description
Overweight and obesity are now considered a growing public health problem in Mexico and worldwide. This epidemic has been attributed to dietary fructose consumption. Although experimental models have demonstrated a role of fructose in the development of obesity, metabolic syndrome and kidney disease, data in human models is lacking. The purpose of this study is to determine if a low fructose intake could have an impact on the components of the metabolic syndrome. The primary endpoint will be to determine the impact of low fructose on weight loss. Secondary endpoints will evaluate the impact of low fructose diet on blood pressure and cardiovascular biochemical profile.
If fructose is a causal pathway to obesity and metabolic syndrome, it may represent an important target to mitigate this important health problem.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Metabolic Syndrome, Hyperuricemia
Keywords
Role of Fructose in overweight and obesity, Fructose and metabolic syndrome, Low fructose diet study, Effects of fructose in blood pressure and hypertension, Somatometry changes observed in fructose diets, Fructose induced overweight and obesity, Fructose induced metabolic syndrome, Fructose induced hyperuricemia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low fructose arm
Arm Type
Active Comparator
Arm Description
Overweighted or obese previously healthy adults (with no other comorbidities, defined as: Diabetes (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of >25 kilograms(weight)/ squared meters (height).
They will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and rest energy (without exercise).
This group will be assigned to a 2 week period of low fructose diet (less than 10 grams/day ) followed by a 4 week period of less than 20 grams/day fructose diet levels.
Total Time of intervention 6 weeks for each patient
Arm Title
Normal fructose arm
Arm Type
Active Comparator
Arm Description
Overweighted or obese previously healthy adults (with no other comorbidities; defined as: Diabetes Mellitus (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of >25 kilograms(weight)/ squared meters (height).
Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet (of 15% proteins, 30% lipids and 55% carbohydrates); calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise).
This group will receive a controlled fructose diet between 50 and 70 grams/day of fructose intake.
Total time of intervention:6 weeks for each patient
Intervention Type
Dietary Supplement
Intervention Name(s)
low fructose
Intervention Description
patients will receive a low fructose diet to evaluate possible changes in weight loss after a 6 week period of receiving a caloric intake (proteins, fats and carbohydrates) based on their healthy-desired weight. Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). low fructose arm: a 2 week period of low fructose diet (less than 10 grams/day ) followed by a 4 week period of "healthy" fructose diet levels (less than 20 grams/day).Baseline measurements and weekly monitoring of somatometry parameters (BMI, %body fat, waist and hip Index, blood pressure), lipid profile and uric acid levels will be done.
Intervention Type
Dietary Supplement
Intervention Name(s)
Normal fructose arm
Other Intervention Name(s)
NORMAL FRUCTOSE
Intervention Description
patients will receive a normal fructose diet to evaluate possible changes in weight loss after a 6 week period of receiving a caloric intake (proteins, fats and carbohydrates) based on their healthy-desired weight. Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). Normal fructose arm: participants will receive a 6 week period of normal fructose diet between 50 to 70 grams/day. Baseline measurements and weekly monitoring of somatometry parameters (BMI, %body fat, waist and hip Index, blood pressure), lipid profile and uric acid levels will be done.
Primary Outcome Measure Information:
Title
Somatometry: including weight, height, Body Mass Index (BMI), % Body fat levels, waist and hip index, and blood pressure levels measurements performed by a single evaluator and calibrated equipment
Description
measurements will be performed by a trained evaluator
Time Frame
results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient)
Secondary Outcome Measure Information:
Title
Blood samples: to evaluate metabolic syndrome parameters
Description
samples will be obtained after an eight fasting period
Time Frame
basal and final (6 weeks interval between the basal and final results, for each patient)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals with a Body Mass Index (BMI) > 25. BMI defined as: Weight in kilograms divided by Height (squared) in meters.
Residents of Mexico city
Healthy individuals (no comorbidities or drug prescription for associated chronic diseases)
Exclusion Criteria:
Diabetes Mellitus Type 1 or 2
Severe Hypertension (defined as systolic blood pressure > 160 mmHg and /or diastolic blood pressure > 100 mmHg) and/or Hypertension on pharmacological treatment.
Chronic Kidney Disease (Glomerular Filtration Rate (GFR) < 60 ml/min)
Hepatic Damage or Advanced Disease (clinical, biochemical or histological)
Patient receiving any pharmacological treatments for hypercholesterolemia and/or elevated triglycerides.
Anemia (any etiology)
Malignancy
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Madero, MD
Organizational Affiliation
Instituto Nacional de Cardiología Ignacio Chávez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cardiología Igancio Chávez
City
Mexico
State/Province
Mexico city
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
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The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
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