Preservation of Fat Free Mass During Weight Loss
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 29
- Primary Endpoint
- Fat Free Mass
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Masking Description
Single blinded
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Protein group
4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
Intervention: Whey protein supplementation (Dietary Supplement)
Protein group
4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
Intervention: walking program (Other)
Protein group
4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
Intervention: Very Low Calorie Diet (Other)
Placebo group
4 weeks of a Very Low Calorie Diet (VLCD) + walking program
Intervention: walking program (Other)
Placebo group
4 weeks of a Very Low Calorie Diet (VLCD) + walking program
Intervention: Very Low Calorie Diet (Other)
Outcomes
Primary Outcomes
Fat Free Mass
Time Frame: Change from baseline to after the 4 week intervention period
Dual energy X-ray absorptiometry (DXA)
Secondary Outcomes
- Oral glucose tolerance test(Change from baseline to after the 4 week intervention period)
- Nitrogen balance(Change in nitrogen content from baseline to day 7 and 28 of the intervention period)
- Fitness level(Change from baseline to after the 4 week intervention period)
- Blood pressure(Change from baseline to after the 4 week intervention period)
- Fat mass(Change from baseline to after the 4 week intervention period)
- waist circumference(Change from baseline to after the 4 week intervention period)
- Performance test(Change from baseline to after the 4 week intervention period)