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Diet and Body Composition (CENTRAL)

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ClinicalTrials.gov Identifier: NCT01530724
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Iris Shai, Ben-Gurion University of the Negev

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Other: Weight-loss diet strategy (+) exercise (PA) Other: weight loss (-) exercise (PA) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (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
Study Start Date : October 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: low fat diet
Weight-loss diet strategy
 Other: Weight-loss diet strategy (+) exercise (PA)
Weight-loss diet strategy with a free gym membership; monthly 60-minute educational workshops; 3 sessions of workout per week of mostly aerobic training

Other: weight loss (-) exercise (PA)
Weight-loss diet strategy without exercise
Experimental: low carb diet
Weight-loss diet strategy
 Other: Weight-loss diet strategy (+) exercise (PA)
Weight-loss diet strategy with a free gym membership; monthly 60-minute educational workshops; 3 sessions of workout per week of mostly aerobic training

Other: weight loss (-) exercise (PA)
Weight-loss diet strategy without exercise


Outcome Measures
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Primary Outcome Measures :
  1. body fat composition [ Time Frame: 0, 6,18 months ]
    changes in body fat (MRI)

  2. obesity [ Time Frame: 0, 6, 18 months ]
    changes in weight

  3. abdominal obesity [ Time Frame: 0, 6, 18 months ]
    changes in waist circumference


Secondary Outcome Measures :
  1. Lipid profile [ Time Frame: 0, 6, 18 months ]
    Changes in lipid biomarkers: total cholesterol (mg/dL), triglycerides (mg/dL), HDLc (mg/dL), LDLc (mg/dL) (blood draw)

  2. Glycemic control [ Time Frame: 0, 6, 18 months ]
    Changes in fasting glucose (mg/dL) (blood draw)

  3. Glycemic control [ Time Frame: 0, 6, 18 months ]
    Changes in insulin (μIU/mL) (blood draw)

  4. Inflammatory state [ Time Frame: 0, 6, 18 months ]
    Changes hsCRP (mg/L) (blood draw)

  5. Metabolomic [ Time Frame: 0, 6, 18 months ]
    Changes in sub-lipids (blood draw)

  6. Metabolomic [ Time Frame: 0, 6, 18 months ]
    Changes in sub-proteins ( blood draw)

  7. Liver function (blood biomarkers) [ Time Frame: 0, 6, 18 months ]
    Changes in ALT (U/l), AST (U/l), ALKP (U/I), GGT (U/l) (blood draw)

  8. Genetic signature [ Time Frame: baseline ]
    SNPs (variants) associated with fat distribution and visceral fat (blood draw)

  9. Epigenetics [ Time Frame: 0, 6, 18 months ]
    changes in genes' methylation (blood draw)

  10. Epigenetics [ Time Frame: 0, 6, 18 months ]
    changes in mRNAs (blood draw)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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 and high-density-lipoprotein cholesterol [HDL-c] <40 mg/dL for men and <50 mg/dL for women

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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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): NCT01530724


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

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

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Responsible Party: Iris Shai, Iris Shai, RD PhD, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT01530724    
Other Study ID Numbers: ISF256/09
256/09 ( Other Grant/Funding Number: ISF256/09 )
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Keywords provided by Iris Shai, Ben-Gurion University of the Negev:
abdominal obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight