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

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ClinicalTrials.gov Identifier: NCT00160108
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 20, 2018
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

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

Condition or disease Intervention/treatment Phase
Obesity CHD Behavioral: dietary intervention Phase 1

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

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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



Primary Outcome Measures :
  1. weight loss

Secondary Outcome Measures :
  1. CVD mediators measurements


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

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


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

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ClinicalTrials.gov Identifier: NCT00160108     History of Changes
Other Study ID Numbers: DR300-3
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: September 2006