Status:
COMPLETED
A Dietary Intervention- Randomized Controlled Trial (DIRECT) Study; BGU-Harvard-Robarts Collaboration
Lead Sponsor:
The S. Daniel Abraham International Center for Health and Nutrition
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
University of Western Ontario, Canada
Conditions:
Obesity
CHD
Eligibility:
All Genders
40+ years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- BMI\>27
- age\>40
- History of CHD or diabetes in any age or BMI level
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00160108
Start Date
July 1 2005
End Date
July 1 2007
Last Update
March 20 2018
Active Locations (1)
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1
Medical Center, The Nuclear Research Center
Dimona, Israel, 70700