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Completed

NCT Number: NCT00868673

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

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).

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Key information

Conditions

Overweight and Obesity Body Weight Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Hyperuricemia Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Cardiología Igancio Chávez

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low fructose

Dietary Supplement

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.

Normal fructose arm

Dietary Supplement

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 names: NORMAL FRUCTOSE

Primary outcomes

  1. 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)

    measurements will be performed by a trained evaluator

Secondary outcomes

  1. Blood samples: to evaluate metabolic syndrome parameters

    Time frame: basal and final (6 weeks interval between the basal and final results, for each patient)

    samples will be obtained after an eight fasting period

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Mar 25, 2009
Registry last updated
Jul 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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