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Completed

NCT Number: NCT00160108

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

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Center, The Nuclear Research Center

Dimona, 70700, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dietary intervention

Behavioral

Primary outcomes

  1. weight loss

Secondary outcomes

  1. CVD mediators measurements

Sponsors and collaborators

Lead sponsor

The S. Daniel Abraham International Center for Health and Nutrition

Other

Collaborators

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

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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