Clinical trial NCT00868673: The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
Official title: The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

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 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

Primary outcomes:
measure: 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
timeFrame: results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient)
Secondary outcomes:
measure: Blood samples: to evaluate metabolic syndrome parameters
timeFrame: basal and final (6 weeks interval between the basal and final results, for each patient)
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Cardiología Igancio Chávez
state: Mexico city
Study officials:
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Magdalena Madero, MD
role: PRINCIPAL_INVESTIGATOR
References: