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

First Received on September 8, 2005. Last Updated on September 11, 2006 History of Changes

Sponsor:	The S. Daniel Abraham International Center for Health and Nutrition
Collaborators:	Harvard School of Public Health Robarts Research Institute Soroka University Medical Center Brigham and Women's Hospital Harvard University 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

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 I

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:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

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

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

Robarts Research Institute

Soroka University Medical Center

Brigham and Women's Hospital

Harvard University

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:

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. No abstract available.

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

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. 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. 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. 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. 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.

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 February 08, 2012