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

The S. Daniel Abraham International Center for Health and Nutrition1 site in 1 country300 target enrollmentJuly 2005

ConditionsObesity CHD

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Obesity
Sponsor: The S. Daniel Abraham International Center for Health and Nutrition
Enrollment: 300
Locations: 1
Primary Endpoint: weight loss
Status: Completed
Last Updated: 8 years ago

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

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

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

July 2007

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

The S. Daniel Abraham International Center for Health and Nutrition

•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).