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).

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Overweight and Obesity; Hyperuricemia
• Intervention / Treatment: Dietary supplement: low fructose; Dietary supplement: Normal fructose arm

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico city
    • Mexico, Mexico city, Mexico, 14080
      • Instituto Nacional de Cardiología Igancio Chávez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood samples: to evaluate metabolic syndrome parameters	samples will be obtained after an eight fasting period	basal and final (6 weeks interval between the basal and final results, for each patient)

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Investigators: Principal Investigator: Magdalena Madero, MD, Instituto Nacional de Cardiologia Ignacio Chavez

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): March 25, 2009

Study Record Updates

• Last Update Posted (Estimate): July 9, 2010
• Last Update Submitted That Met QC Criteria: July 8, 2010
• Last Verified: November 1, 2009

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Metabolic Syndrome; Overweight; Hyperuricemia
• Other Study ID Numbers: FRUCTOSE 09-630