Diet and Body Composition (CENTRAL)

This study is currently recruiting participants.

Verified February 2012 by Ben-Gurion University of the Negev

Sponsor:

Information provided by (Responsible Party):

Iris Shai, Ben-Gurion University of the Negev

ClinicalTrials.gov Identifier:

NCT01530724

First received: February 8, 2012

Last updated: February 11, 2012

Last verified: February 2012

History of Changes

Purpose

The investigators hypothesize that differential dynamics in fat depots in response to two opposing dietary strategies mediate the beneficial metabolic effects during weight loss and regain phases.

Condition	Intervention	Phase
Obesity	Other: low-fat diet Other: low-carb diet	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effect of Weight-loss Diet Strategies and Exercise on Dynamics of Body Fat Depots and Metabolic Rate

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Ben-Gurion University of the Negev:

Primary Outcome Measures:

body fat composition [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	February 2012
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PA (Exercise )+	Other: low-fat diet low-fat diet Other: low-carb diet low-carb diet
Experimental: PA (Exercise ) -	Other: low-fat diet low-fat diet Other: low-carb diet low-carb diet

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Elevated waist circumference:
- Men: > 40 inches (102 cm)
- Women> 35 inches (88 cm)
Poor dieters with TG>150mg/dL

Exclusion Criteria:

Pregnant or lactating women
Serum creatinine LT 2 mg/dl
Disturbed liver function (LT 3 fold level of ALT and AST enzymes)
Active cancer
Individuals who cannot start physical activity in the gym
Individuals that are highly physically active (more than 4 hours/week)
Active in other nutritional trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530724

Contacts

Contact: Iris Shai, PhD

++972-8-6477443

irish@bgu.ac.il

Locations

Israel
nuclear research center Negev	Recruiting
Dimona, Israel
Principal Investigator: Dan Schwarzfuchs, MD

Sponsors and Collaborators

Ben-Gurion University of the Negev

More Information

Publications:

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.

Responsible Party:	Iris Shai, Iris Shai, RD PhD, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier:	NCT01530724 History of Changes
Other Study ID Numbers:	ISF256/09, 256/09
Study First Received:	February 8, 2012
Last Updated:	February 11, 2012
Health Authority:	Israel: Ministry of Health

Keywords provided by Ben-Gurion University of the Negev:

abdominal obesity

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013

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