Clinical trial NCT01530724: Diet and Body Composition
Official title: Effect of Weight-loss Diet Strategies and Exercise on Dynamics of Body Fat Depots and Metabolic Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: abdominal obesity
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 224
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: body fat composition
timeFrame: 0, 6,18 months
measure: obesity
timeFrame: 0, 6, 18 months
measure: abdominal obesity
timeFrame: 0, 6, 18 months
Secondary outcomes:
measure: Lipid profile
timeFrame: 0, 6, 18 months
measure: Glycemic control
timeFrame: 0, 6, 18 months
measure: Glycemic control
timeFrame: 0, 6, 18 months
measure: Inflammatory state
timeFrame: 0, 6, 18 months
measure: Metabolomic
timeFrame: 0, 6, 18 months
measure: Metabolomic
timeFrame: 0, 6, 18 months
measure: Liver function (blood biomarkers)
timeFrame: 0, 6, 18 months
measure: Genetic signature
timeFrame: baseline
measure: Epigenetics
timeFrame: 0, 6, 18 months
measure: Epigenetics
timeFrame: 0, 6, 18 months
Other outcomes:
Locations:
city: Dimona
country: Israel
facility: nuclear research center Negev
Study officials:
References:
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