The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Overweight and Obesity Metabolic Syndrome Hyperuricemia |
Dietary Supplement: low fructose Dietary Supplement: Normal fructose arm |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome |
- 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 [ Time Frame: results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient) ] [ Designated as safety issue: Yes ]measurements will be performed by a trained evaluator
- Blood samples: to evaluate metabolic syndrome parameters [ Time Frame: basal and final (6 weeks interval between the basal and final results, for each patient) ] [ Designated as safety issue: Yes ]samples will be obtained after an eight fasting period
| Enrollment: | 120 |
| Study Start Date: | March 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Low fructose arm
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 |
Dietary Supplement: low fructose
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.
Other Name: LOW FRUCTOSE
|
|
Active Comparator: Normal fructose arm
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 |
Dietary Supplement: Normal fructose arm
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.
Other Name: NORMAL FRUCTOSE
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Mexico | |
| Instituto Nacional de Cardiología Igancio Chávez | |
| Mexico, Mexico city, Mexico, 14080 | |
| Principal Investigator: | Magdalena Madero, MD | Instituto Nacional de Cardiología Ignacio Chávez |
More Information
No publications provided
| Responsible Party: | MD Magdalena Madero R., Instituto Nacional de Cardiología Ignacio Chávez |
| ClinicalTrials.gov Identifier: | NCT00868673 History of Changes |
| Other Study ID Numbers: | FRUCTOSE 09-630 |
| Study First Received: | March 24, 2009 |
| Last Updated: | July 8, 2010 |
| Health Authority: | Mexico: National Institute of Public Health, Health Secretariat |
Keywords provided by Instituto Nacional de Cardiologia Ignacio Chavez:
|
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 |
Additional relevant MeSH terms:
|
Obesity Overweight Metabolic Syndrome X Hyperuricemia Overnutrition Nutrition Disorders Body Weight Signs and Symptoms Insulin Resistance Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Pathologic Processes Uric Acid Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013