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

Study Description

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

Study Design

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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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

weight loss

Secondary Outcome Measures :

CVD mediators measurements

Eligibility Criteria

Information from the National Library of Medicine

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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).

Contacts and Locations

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

More Information

Publications:

National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421.

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

Zheng Y, Ceglarek U, Huang T, Li L, Rood J, Ryan DH, Bray GA, Sacks FM, Schwarzfuchs D, Thiery J, Shai I, Qi L. Weight-loss diets and 2-y changes in circulating amino acids in 2 randomized intervention trials. Am J Clin Nutr. 2016 Feb;103(2):505-11. doi: 10.3945/ajcn.115.117689. Epub 2016 Jan 20.

Tirosh A, Golan R, Harman-Boehm I, Henkin Y, Schwarzfuchs D, Rudich A, Kovsan J, Fiedler GM, Blüher M, Stumvoll M, Thiery J, Stampfer MJ, Shai I. Renal function following three distinct weight loss dietary strategies during 2 years of a randomized controlled trial. Diabetes Care. 2013 Aug;36(8):2225-32. doi: 10.2337/dc12-1846. Epub 2013 May 20.

Canfi A, Gepner Y, Schwarzfuchs D, Golan R, Shahar DR, Fraser D, Witkow S, Greenberg I, Sarusi B, Vardi H, Friger M, Stampfer MJ, Shai I. Effect of changes in the intake of weight of specific food groups on successful body weight loss during a multi-dietary strategy intervention trial. J Am Coll Nutr. 2011 Dec;30(6):491-501.

Blüher M, Rudich A, Klöting N, Golan R, Henkin Y, Rubin E, Schwarzfuchs D, Gepner Y, Stampfer MJ, Fiedler M, Thiery J, Stumvoll M, Shai I. Two patterns of adipokine and other biomarker dynamics in a long-term weight loss intervention. Diabetes Care. 2012 Feb;35(2):342-9. doi: 10.2337/dc11-1267. Epub 2011 Dec 21.

Leichtle AB, Helmschrodt C, Ceglarek U, Shai I, Henkin Y, Schwarzfuchs D, Golan R, Gepner Y, Stampfer MJ, Blüher M, Stumvoll M, Thiery J, Fiedler GM. Effects of a 2-y dietary weight-loss intervention on cholesterol metabolism in moderately obese men. Am J Clin Nutr. 2011 Nov;94(5):1189-95. doi: 10.3945/ajcn.111.018119. Epub 2011 Sep 21.

Golan R, Tirosh A, Schwarzfuchs D, Harman-Boehm I, Thiery J, Fiedler GM, Blüher M, Stumvoll M, Shai I; DIRECT Group. Dietary intervention induces flow of changes within biomarkers of lipids, inflammation, liver enzymes, and glycemic control. Nutrition. 2012 Feb;28(2):131-7. doi: 10.1016/j.nut.2011.04.001. Epub 2011 Aug 6.

Shahar DR, Schwarzfuchs D, Fraser D, Vardi H, Thiery J, Fiedler GM, Blüher M, Stumvoll M, Stampfer MJ, Shai I; DIRECT Group. Dairy calcium intake, serum vitamin D, and successful weight loss. Am J Clin Nutr. 2010 Nov;92(5):1017-22. doi: 10.3945/ajcn.2010.29355. Epub 2010 Sep 1.

Shai I, Spence JD, Schwarzfuchs D, Henkin Y, Parraga G, Rudich A, Fenster A, Mallett C, Liel-Cohen N, Tirosh A, Bolotin A, Thiery J, Fiedler GM, Blüher M, Stumvoll M, Stampfer MJ; DIRECT Group. Dietary intervention to reverse carotid atherosclerosis. Circulation. 2010 Mar 16;121(10):1200-8. doi: 10.1161/CIRCULATIONAHA.109.879254. Epub 2010 Mar 1.

Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, Golan R, Fraser D, Bolotin A, Vardi H, Tangi-Rozental O, Zuk-Ramot R, Sarusi B, Brickner D, Schwartz Z, Sheiner E, Marko R, Katorza E, Thiery J, Fiedler GM, Blüher M, Stumvoll M, Stampfer MJ; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. doi: 10.1056/NEJMoa0708681. Erratum in: N Engl J Med. 2009 Dec 31;361(27):2681.

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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

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