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Diet and Body Composition (CENTRAL)

This study has been completed.
Information provided by (Responsible Party):
Iris Shai, Ben-Gurion University of the Negev Identifier:
First received: February 8, 2012
Last updated: September 29, 2015
Last verified: September 2015
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
Other: low-fat diet
Other: low-carb diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Care Provider, 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

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

Primary Outcome Measures:
  • body fat composition [ Time Frame: October 2012 - April 2014 ]

Enrollment: 224
Study Start Date: October 2012
Study Completion Date: April 2014
Primary Completion Date: April 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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01530724

nuclear research center Negev
Dimona, Israel
Sponsors and Collaborators
Ben-Gurion University of the Negev
  More Information

Responsible Party: Iris Shai, Iris Shai, RD PhD, Ben-Gurion University of the Negev Identifier: NCT01530724     History of Changes
Other Study ID Numbers: ISF256/09
256/09 ( Other Grant/Funding Number: ISF256/09 )
Study First Received: February 8, 2012
Last Updated: September 29, 2015

Keywords provided by Ben-Gurion University of the Negev:
abdominal obesity processed this record on May 22, 2017