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The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome

Not Applicable
Completed
Conditions
Overweight and Obesity
Metabolic Syndrome
Hyperuricemia
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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 equipmentresults 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
NameTimeMethod
Blood samples: to evaluate metabolic syndrome parametersbasal 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

Instituto Nacional de Cardiología Igancio Chávez
🇲🇽Mexico, Mexico city, Mexico

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