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

Phase 1

Completed

• Conditions: CHD; Obesity

• 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

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-12
• Status Verified: 2006-09
• Study Completion: 2007-07
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-20

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