Preservation of Fat Free Mass During Weight Loss

NCT ID: NCT03102372

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-08

Study Completion Date

2016-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized single blinded, controlled intervention trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Single blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Protein group

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

Group Type EXPERIMENTAL

Whey protein supplementation

Intervention Type DIETARY_SUPPLEMENT

walking program

Intervention Type OTHER

Very Low Calorie Diet

Intervention Type OTHER

Placebo group

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

Group Type PLACEBO_COMPARATOR

walking program

Intervention Type OTHER

Very Low Calorie Diet

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whey protein supplementation

Intervention Type DIETARY_SUPPLEMENT

walking program

Intervention Type OTHER

Very Low Calorie Diet

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Orkla Health

UNKNOWN

Sponsor Role collaborator

Toyota-Fonden

OTHER

Sponsor Role collaborator

Tømmerhandler Vilhelm Bangs Fond

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mette Hansen, Lector

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Section of Sport Science, AU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.