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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868673
• Other study ID #: FRUCTOSE 09-630
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: July 8, 2010
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: November 2009
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Hyperuricemia
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Overweight
• Overweight and Obesity
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiología Igancio Chávez	Mexico	Mexico city

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes