Overview

This trial is active, not recruiting.

Conditions obesity, chd
Treatment dietary intervention
Phase phase 1
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

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
weight loss
time frame:

Secondary Outcomes

Measure
CVD mediators measurements
time frame:

Eligibility Criteria

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).

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by The S. Daniel Abraham International Center for Health and Nutrition.