Diet and Body Composition (CENTRAL)

This study has been completed.
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: September 29, 2015
Last verified: September 2015
  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:


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

Primary Outcome Measures:
  • body fat composition [ Time Frame: October 2012 - April 2014 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
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: September 29, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by Ben-Gurion University of the Negev:
abdominal obesity

ClinicalTrials.gov processed this record on July 27, 2016