A Dietary Intervention- Randomized Controlled Trial (DIRECT) Study; BGU-Harvard-Robarts Collaboration
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00160108 |
Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : March 20, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity CHD | Behavioral: dietary intervention | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Actual Study Start Date : | July 2005 |
Actual Study Completion Date : | July 2007 |
- weight loss
- CVD mediators measurements

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160108
Israel | |
Medical Center, The Nuclear Research Center | |
Dimona, Israel, 70700 |
Principal Investigator: | Iris Shai, RD, PhD | Ben-Gurion University of the Negev | |
Study Chair: | Meir J Stampfer, MD, DrPH | Departments of Epidemiology and Nutrition, Harvard School of Public Health, Boston, Massachusetts, USA | |
Study Chair: | David Spence, MD | Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute, London, Canada |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00160108 |
Other Study ID Numbers: |
DR300-3 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | March 20, 2018 |
Last Verified: | September 2006 |