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

March 19, 2018 updated by: The S. Daniel Abraham International Center for Health and Nutrition
Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment

300

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Dimona, Israel, 70700
        • Medical Center, The Nuclear Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
weight loss

Secondary Outcome Measures

Outcome Measure
CVD mediators measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The S. Daniel Abraham International Center for Health and Nutrition

Collaborators

Harvard Medical School (HMS and HSDM)
Brigham and Women's Hospital
University of Western Ontario, Canada
Harvard School of Public Health (HSPH)
Soroka University Medical Center
Ben-Gurion University of the Negev
The Nuclear Research Center, Dimona

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

September 1, 2006

More Information

Terms related to this study

Other Study ID Numbers

  • DR300-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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