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Preservation of Fat Free Mass During Weight Loss

Preservation of Fat Free Mass During Weight Loss

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03102372
Enrollment
29
Registered
2017-04-05
Start date
2016-01-08
Completion date
2016-05-02
Last updated
2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Loss

Keywords

FFM, VLCD, exercise, Protein, Obesity

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.

Interventions

Sponsors

Orkla Health
CollaboratorUNKNOWN
Toyota-Fonden
CollaboratorOTHER
Tømmerhandler Vilhelm Bangs Fond
CollaboratorUNKNOWN
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Single blinded

Intervention model description

Randomized single blinded, controlled intervention trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Fat Free MassChange from baseline to after the 4 week intervention periodDual energy X-ray absorptiometry (DXA)

Secondary

MeasureTime frameDescription
Oral glucose tolerance testChange from baseline to after the 4 week intervention periodOGTT
Fitness levelChange from baseline to after the 4 week intervention periodBike test
Blood pressureChange from baseline to after the 4 week intervention periodBlood pressure at rest
Nitrogen balanceChange in nitrogen content from baseline to day 7 and 28 of the intervention periodThree 24 hours urin samples
waist circumferenceChange from baseline to after the 4 week intervention periodwaist circumference
Performance testChange from baseline to after the 4 week intervention periodIntermittent running test (YY1R1C)
Fat massChange from baseline to after the 4 week intervention periodDXA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026