A Dietary Intervention- Randomized Controlled Trial (DIRECT) Study; BGU-Harvard–Robarts Collaboration
This trial is active, not recruiting.
|Sponsor||The S. Daniel Abraham International Center for Health and Nutrition|
|Collaborator||Harvard School of Public Health|
|Start date||July 2005|
|End date||July 2007|
|Trial size||300 participants|
|Trial identifier||NCT00160108, DR300-3|
Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
CVD mediators measurements
Male or female participants at least 40 years old.
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).
|Principal investigator||Iris Shai, RD, PhD|
|Description||Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss|
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