Preservation of Fat Free Mass During Weight Loss

April 5, 2017 updated by: University of Aarhus

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Protein group
4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
Dietary supplement: Whey protein supplementation
Other: walking program
Other: Very Low Calorie Diet
PLACEBO_COMPARATOR: Placebo group
4 weeks of a Very Low Calorie Diet (VLCD) + walking program
Other: walking program
Other: Very Low Calorie Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat Free Mass
Time Frame: Change from baseline to after the 4 week intervention period
Dual energy X-ray absorptiometry (DXA)
Change from baseline to after the 4 week intervention period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Toyota-Fonden
Orkla Health
Tømmerhandler Vilhelm Bangs Fond

Investigators

  • Principal Investigator: Mette Hansen, Lector, Aarhus University, Department for Public Health, Section for Sport Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2016

Primary Completion (ACTUAL)

April 4, 2016

Study Completion (ACTUAL)

May 2, 2016

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (ACTUAL)

April 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Section of Sport Science, AU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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