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

This study has been completed.
Sponsor:
Information provided by:
Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT00868673
First received: March 24, 2009
Last updated: July 8, 2010
Last verified: November 2009
  Purpose

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 Intervention
Overweight and Obesity
Metabolic Syndrome
Hyperuricemia
Dietary Supplement: low fructose
Dietary Supplement: Normal fructose arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cardiologia Ignacio Chavez:

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 [ Time Frame: results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient) ] [ Designated as safety issue: Yes ]
    measurements will be performed by a trained evaluator


Secondary Outcome Measures:
  • Blood samples: to evaluate metabolic syndrome parameters [ Time Frame: basal and final (6 weeks interval between the basal and final results, for each patient) ] [ Designated as safety issue: Yes ]
    samples will be obtained after an eight fasting period


Enrollment: 120
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: LOW FRUCTOSE
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 Name: NORMAL FRUCTOSE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868673

Locations
Mexico
Instituto Nacional de Cardiología Igancio Chávez
Mexico, Mexico city, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
Principal Investigator: Magdalena Madero, MD Instituto Nacional de Cardiología Ignacio Chávez
  More Information

No publications provided

Responsible Party: MD Magdalena Madero R., Instituto Nacional de Cardiología Ignacio Chávez
ClinicalTrials.gov Identifier: NCT00868673     History of Changes
Other Study ID Numbers: FRUCTOSE 09-630
Study First Received: March 24, 2009
Last Updated: July 8, 2010
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Instituto Nacional de Cardiologia Ignacio Chavez:
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:
Obesity
Metabolic Syndrome X
Overweight
Hyperuricemia
Syndrome
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Disease
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014