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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by The S. Daniel Abraham International Center for Health and Nutrition.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Harvard School of Public Health
University of Western Ontario, Canada
Soroka University Medical Center
Brigham and Women's Hospital
Harvard Medical School
The Nuclear Research Center, Dimona
Ben-Gurion University of the Negev
Information provided by:
The S. Daniel Abraham International Center for Health and Nutrition
ClinicalTrials.gov Identifier:
NCT00160108
First received: September 8, 2005
Last updated: September 11, 2006
Last verified: September 2006
  Purpose

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


Condition Intervention Phase
Obesity
CHD
Behavioral: dietary intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by The S. Daniel Abraham International Center for Health and Nutrition:

Primary Outcome Measures:
  • weight loss

Secondary Outcome Measures:
  • CVD mediators measurements

Estimated Enrollment: 300
Study Start Date: July 2005
Estimated Study Completion Date: July 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160108

Locations
Israel
Medical Center, The Nuclear Research Center
Dimona, Israel, 70700
Sponsors and Collaborators
The S. Daniel Abraham International Center for Health and Nutrition
Harvard School of Public Health
University of Western Ontario, Canada
Soroka University Medical Center
Brigham and Women's Hospital
Harvard Medical School
The Nuclear Research Center, Dimona
Ben-Gurion University of the Negev
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00160108     History of Changes
Other Study ID Numbers: DR300-3
Study First Received: September 8, 2005
Last Updated: September 11, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014