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

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez (Other)

Overall Status

Completed

CT.gov ID

NCT00868673

Collaborator

(none)

120

Enrollment

Location

Arms

11.1

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Metabolic Syndrome Hyperuricemia	Dietary Supplement: low fructose Dietary Supplement: Normal fructose arm	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Dietary Supplement: 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.
Active Comparator: 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	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. Other Names: NORMAL FRUCTOSE

Arm

Intervention/Treatment

Active Comparator: 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

Dietary Supplement: 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.

Active Comparator: 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

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.

Other Names:

NORMAL FRUCTOSE

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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