Preservation of Fat Free Mass During Weight Loss

NCT03102372 — Not applicable, Completed, 29 participants, University of Aarhus

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Registry	NCT03102372
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, basic science
Enrollment	29 (Actual)
Sponsor	University of Aarhus (Other); collaborators: Orkla Health, Toyota-Fonden, Tømmerhandler Vilhelm Bangs Fond
Conditions	Muscle Loss
Interventions	Whey protein supplementation, walking program, Very Low Calorie Diet (Dietary supplement, other)
Dates	start 2016-01-08, primary completion 2016-04-04, completion 2016-05-02, first posted 2017-04-05, last updated 2017-04-07

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Protein group	Experimental	Dietary Supplement: Whey protein supplementation; Other: walking program; Other: Very Low Calorie Diet	4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
Placebo group	Placebo comparator	Other: walking program; Other: Very Low Calorie Diet	4 weeks of a Very Low Calorie Diet (VLCD) + walking program

Whey protein supplementation (Dietary supplement)
walking program (Other)
Very Low Calorie Diet (Other)

+Outcome measures

Primary outcomes

Fat Free Mass [Change from baseline to after the 4 week intervention period]: Dual energy X-ray absorptiometry (DXA)

Secondary outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.

+Investigators

Mette Hansen, Lector, Principal investigator, Aarhus University, Department for Public Health, Section for Sport Science

My Notes

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