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

NCT ID: NCT00868673

Last Updated: 2010-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-02-28

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.

Conditions

Overweight and Obesity; Metabolic Syndrome; Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

low fructose

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Normal fructose arm

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

NORMAL FRUCTOSE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role: lead

Responsible Party

Instituto Nacional de Cardiología Ignacio Chávez

Principal Investigators

Magdalena Madero, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cardiología Ignacio Chávez

Locations

Instituto Nacional de Cardiología Igancio Chávez

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

FRUCTOSE 09-630

Identifier Type: -

Identifier Source: org_study_id