Preservation of Fat Free Mass During Weight Loss

Not Applicable

Completed

• Conditions: Muscle Loss
• Interventions: Dietary Supplement: Whey protein supplementation; Other: Very Low Calorie Diet; Other: walking program

• Registration Number: NCT03102372
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-08
• Primary Completion: 2016-04-04
• Study Completion: 2016-05-02
• Status Verified: 2017-02
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-05
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Body Mass Index (kg/m^2) > 28
• Age between 18 and 55 years

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Very Low Calorie Diet	4 weeks of a Very Low Calorie Diet (VLCD) + walking program
Protein group	Whey protein supplementation	4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
Protein group	Very Low Calorie Diet	4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
Protein group	walking program	4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
Placebo group	walking program	4 weeks of a Very Low Calorie Diet (VLCD) + walking program

Primary Outcome Measures

Name	Time	Method
Fat Free Mass	Change from baseline to after the 4 week intervention period	Dual energy X-ray absorptiometry (DXA)

Secondary Outcome Measures

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