NCT03102372

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2016

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
Last Updated

April 7, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

March 10, 2017

Last Update Submit

April 5, 2017

Conditions

Muscle Loss

Keywords

FFMVLCDexerciseProteinObesity

Outcome Measures

Primary Outcomes (1)

  • Fat Free Mass

    Dual energy X-ray absorptiometry (DXA)

    Change from baseline to after the 4 week intervention period

Secondary Outcomes (7)

  • Nitrogen balance

    Change in nitrogen content from baseline to day 7 and 28 of the intervention period

  • Oral glucose tolerance test

    Change from baseline to after the 4 week 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

  • +2 more secondary outcomes

Study Arms (2)

Protein group

EXPERIMENTAL

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

Dietary Supplement: Whey protein supplementationOther: walking programOther: Very Low Calorie Diet

Placebo group

PLACEBO COMPARATOR

4 weeks of a Very Low Calorie Diet (VLCD) + walking program

Other: walking programOther: Very Low Calorie Diet

Interventions

Whey protein supplementationDIETARY_SUPPLEMENT
Protein group
walking programOTHER
Placebo groupProtein group
Very Low Calorie DietOTHER
Placebo groupProtein group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular AtrophyMotor ActivityObesity

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Mette Hansen, Lector

    Aarhus University, Department for Public Health, Section for Sport Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized single blinded, controlled intervention trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

April 5, 2017

Study Start

January 8, 2016

Primary Completion

April 4, 2016

Study Completion

May 2, 2016

Last Updated

April 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share