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

NCT00868673 | Completed

• 1 other identifier: FRUCTOSE 09-630
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight and Obesity; Metabolic Syndrome; Hyperuricemia

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

Outcome Measures

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

  measurements will be performed by a trained evaluator

  results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient)

Secondary Outcomes (1)

• Blood samples: to evaluate metabolic syndrome parameters

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

Study Arms (2)

Low fructose arm

ACTIVE COMPARATOR

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

Normal fructose arm

ACTIVE COMPARATOR

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

Interventions

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.

Low fructose arm

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.

Also known as: NORMAL FRUCTOSE

Normal fructose arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiología Igancio Chávez

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Hyperuricemia; Hypertension

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Magdalena Madero, MD

  Instituto Nacional de Cardiología Ignacio Chávez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2010
• Last Updated: July 9, 2010

Record last verified: 2009-11

Locations

ME (1)