Diet and Body Composition

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Weight-loss Diet Strategies and Exercise on Dynamics of Body Fat Depots and Metabolic Rate

Conditions
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Obesity

Intervention / Treatment
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* Other: Weight-loss diet strategy (+) exercise (PA)
* Other: weight loss (-) exercise (PA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low fat diet<br>Weight-loss diet strategy | Other: Weight-loss diet strategy (+) exercise (PA)<br>* Weight-loss diet strategy with a free gym membership; monthly 60-minute educational workshops; 3 sessions of workout per week of mostly aerobic training<br>Other: weight loss (-) exercise (PA)<br>* Weight-loss diet strategy without exercise<br>|
| Experimental: low carb diet<br>Weight-loss diet strategy | Other: Weight-loss diet strategy (+) exercise (PA)<br>* Weight-loss diet strategy with a free gym membership; monthly 60-minute educational workshops; 3 sessions of workout per week of mostly aerobic training<br>Other: weight loss (-) exercise (PA)<br>* Weight-loss diet strategy without exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body fat composition | changes in body fat (MRI) | 0, 6,18 months | 
| obesity | changes in weight | 0, 6, 18 months | 
| abdominal obesity | changes in waist circumference | 0, 6, 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | Changes in lipid biomarkers: total cholesterol (mg/dL), triglycerides (mg/dL), HDLc (mg/dL), LDLc (mg/dL) (blood draw) | 0, 6, 18 months | 
| Glycemic control | Changes in fasting glucose (mg/dL) (blood draw) | 0, 6, 18 months | 
| Glycemic control | Changes in insulin (μIU/mL) (blood draw) | 0, 6, 18 months | 
| Inflammatory state | Changes hsCRP (mg/L) (blood draw) | 0, 6, 18 months | 
| Metabolomic | Changes in sub-lipids (blood draw) | 0, 6, 18 months | 
| Metabolomic | Changes in sub-proteins ( blood draw) | 0, 6, 18 months | 
| Liver function (blood biomarkers) | Changes in ALT (U/l), AST (U/l), ALKP (U/I), GGT (U/l) (blood draw) | 0, 6, 18 months | 
| Genetic signature | SNPs (variants) associated with fat distribution and visceral fat (blood draw) | baseline | 
| Epigenetics | changes in genes' methylation (blood draw) | 0, 6, 18 months | 
| Epigenetics | changes in mRNAs (blood draw) | 0, 6, 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal obesity