A Dietary Intervention- Randomized Controlled Trial (DIRECT) Study; BGU-Harvard-Robarts Collaboration

The S. Daniel Abraham International Center for Health and Nutrition

Status and phase: Completed; Phase 1

Conditions: CHD; Obesity

Treatments: Behavioral: dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00160108

DR300-3

Details and patient eligibility

About

Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss

Full description

Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)