Preservation of Fat Free Mass During Weight Loss

Study Overview
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Brief Summary
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In this study, we aimed to examine the effect of whey protein supplementation given before night sleep on Fat Free Mass (FFM) preservation during a 4 wk period on Very Low Caloric Diet (VLCD). Half of the participants underwent a 4 week VLCD and walking program, while the other half underwent a 4 week VLCD, walking program and had an additional protein supplement before each night sleep.

Official Title
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Preservation of Fat Free Mass During Weight Loss

Conditions
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Muscle Loss

Intervention / Treatment
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* Dietary Supplement: Whey protein supplementation
* Other: walking program
* Other: Very Low Calorie Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (kg/m^2) > 28 Age between 18 and 55 years Exclusion Criteria: Participation in regular resistance-, aerobic- or anaerobic training (>1 h/wk within the last 3 month before intervention start) Diabetes Physical disabilities that would hinder completion of the walking program.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized single blinded, controlled intervention trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein group<br>4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep. | Dietary Supplement: Whey protein supplementation<br> <br> Other: walking program<br> <br> Other: Very Low Calorie Diet<br> <br> |
| Placebo Comparator: Placebo group<br>4 weeks of a Very Low Calorie Diet (VLCD) + walking program | Other: walking program<br> <br> Other: Very Low Calorie Diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Free Mass | Dual energy X-ray absorptiometry (DXA) | Change from baseline to after the 4 week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitrogen balance | Three 24 hours urin samples | Change in nitrogen content from baseline to day 7 and 28 of the intervention period | 
| Oral glucose tolerance test | OGTT | Change from baseline to after the 4 week intervention period | 
| Fitness level | Bike test | Change from baseline to after the 4 week intervention period | 
| Blood pressure | Blood pressure at rest | Change from baseline to after the 4 week intervention period | 
| Fat mass | DXA | Change from baseline to after the 4 week intervention period | 
| waist circumference | waist circumference | Change from baseline to after the 4 week intervention period | 
| Performance test | Intermittent running test (YY1R1C) | Change from baseline to after the 4 week intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FFM, VLCD, exercise, Protein, Obesity