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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160108
• Other study ID #: DR300-3
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: March 19, 2018
• Start date: July 2005
• Est. completion date: July 2007

Study information

• Verified date: September 2006
• Source: The S. Daniel Abraham International Center for Health and Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• CHD
• Obesity

Intervention

Behavioral:
• dietary intervention

Locations

Country	Name	City	State
Israel	Medical Center, The Nuclear Research Center	Dimona

Sponsors (8)

Lead Sponsor	Collaborator
The S. Daniel Abraham International Center for Health and Nutrition	Ben-Gurion University of the Negev, Brigham and Women's Hospital, Harvard Medical School, Harvard School of Public Health, Soroka University Medical Center, The Nuclear Research Center, Dimona, University of Western Ontario, Canada

Country where clinical trial is conducted

Israel, 

References & Publications (1)

National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss
Secondary	CVD mediators measurements