Overweight and Obesity, Metabolic Syndrome, Hyperuricemia
Conditions
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
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.
Interventions
DIETARY_SUPPLEMENTlow 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.
DIETARY_SUPPLEMENTNormal 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.
Sponsors
Instituto Nacional de Cardiologia Ignacio Chavez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed