The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
- Conditions
- Overweight and ObesityMetabolic SyndromeHyperuricemia
- Interventions
- Dietary Supplement: low fructoseDietary Supplement: Normal fructose arm
- Registration Number
- NCT00868673
- Lead Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low fructose arm low fructose 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 Normal fructose arm 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
- Primary Outcome Measures
Name Time Method 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 results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient) measurements will be performed by a trained evaluator
- Secondary Outcome Measures
Name Time Method Blood samples: to evaluate metabolic syndrome parameters basal and final (6 weeks interval between the basal and final results, for each patient) samples will be obtained after an eight fasting period
Trial Locations
- Locations (1)
Instituto Nacional de Cardiología Igancio Chávez
🇲🇽Mexico, Mexico city, Mexico