A Dietary Intervention- Randomized Controlled Trial (DIRECT) Study; BGU-Harvard-Robarts Collaboration
Phase 1
Completed
- Conditions
- CHDObesity
- Registration Number
- NCT00160108
- Lead Sponsor
- The S. Daniel Abraham International Center for Health and Nutrition
- Brief Summary
Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss
- Detailed Description
Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- BMI>27
- age>40
- History of CHD or diabetes in any age or BMI level
Exclusion Criteria
- Pregnant or lactating women.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Serum creatinine > 3 mg/dl.
- Liver dysfunction ( ³ 2 fold level of ALT and AST enzymes).
- Participation in another trial in which active intervention is being received.
- Any intestinal problem that would prevent the patient from eating one of the test diets (for example, gastric stapling that might prevent consumption of vegetables).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method weight loss
- Secondary Outcome Measures
Name Time Method CVD mediators measurements
Trial Locations
- Locations (1)
Medical Center, The Nuclear Research Center
🇮🇱Dimona, Israel
Medical Center, The Nuclear Research Center🇮🇱Dimona, Israel