Muscle LossNCT03102372
Preservation of Fat Free Mass During Weight Loss
A study testing Whey protein supplementation, walking program and Very Low Calorie Diet in people with Muscle Loss, run by University of Aarhus.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss
- What is being tested?
- Whey protein supplementation, walking program and Very Low Calorie Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2016to 2 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (kg/m^2) > 28
- Age between 18 and 55 years
Who cannot join
- 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.
About this study
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.
- Conditions
- Muscle Loss
- Being tested
- Whey protein supplementation, walking program, Very Low Calorie Diet
- Keywords
- FFM, VLCD, exercise, Protein, Obesity
- Medical subject headings
- Muscular Atrophy, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplementationDietary supplement
walking programOther
Very Low Calorie DietOther
| Study group | Role | What they receive |
|---|---|---|
| Protein group | Experimental | 4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep. Receives: Dietary Supplement: Whey protein supplementation; Other: walking program; Other: Very Low Calorie Diet |
| Placebo group | Placebo comparator | 4 weeks of a Very Low Calorie Diet (VLCD) + walking program Receives: Other: walking program; Other: Very Low Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Free Mass
Dual energy X-ray absorptiometry (DXA)
Measured: Change from baseline to after the 4 week intervention period
Secondary outcomes (7)
Nitrogen balance
Three 24 hours urin samples
Measured: Change in nitrogen content from baseline to day 7 and 28 of the intervention period
Oral glucose tolerance test
OGTT
Measured: Change from baseline to after the 4 week intervention period
Fitness level
Bike test
Measured: Change from baseline to after the 4 week intervention period
Blood pressure
Blood pressure at rest
Measured: Change from baseline to after the 4 week intervention period
Fat mass
DXA
Measured: Change from baseline to after the 4 week intervention period
waist circumference
waist circumference
Measured: Change from baseline to after the 4 week intervention period
Performance test
Intermittent running test (YY1R1C)
Measured: Change from baseline to after the 4 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start8 Jan 2016
- Primary completion4 Apr 2016
- Study completion2 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized single blinded, controlled intervention trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Orkla Health, Toyota-Fonden, Tømmerhandler Vilhelm Bangs Fond
- Responsible party
- Sponsor
- Investigators
- Mette Hansen, Lector, Principal investigator, Aarhus University, Department for Public Health, Section for Sport Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102372
- Sponsor's protocol ID
- Section of Sport Science, AU
- Status last verified
- Feb 2017
- First submitted
- 10 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Fat Free Mass During Weight Loss
- ClinicalTrials.gov ID
- NCT03102372
- Acronym / sponsor ID
- Section of Sport Science, AU
- Conditions
- Muscle Loss
- Keywords
- FFM, VLCD, exercise, Protein, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Orkla Health, Toyota-Fonden, Tømmerhandler Vilhelm Bangs Fond
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 4 Apr 2016 (actual)
- Study completion
- 2 May 2016 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized single blinded, controlled intervention trial
| Arm | Type | Receives |
|---|---|---|
| Protein group | Experimental | Dietary Supplement: Whey protein supplementation, Other: walking program, Other: Very Low Calorie Diet4 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 Diet4 weeks of a Very Low Calorie Diet (VLCD) + walking program |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (kg/m^2) > 28
- Age between 18 and 55 years
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein supplementation | Dietary supplement | Protein group |
| walking program | Other | Placebo group, Protein group |
| Very Low Calorie Diet | Other | Placebo group, Protein group |
Primary outcome
Fat Free Mass
Time frame: Change from baseline to after the 4 week intervention period
Dual energy X-ray absorptiometry (DXA)
7 secondary outcomes
Nitrogen balance
Time frame: 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
Fitness level
Time frame: Change from baseline to after the 4 week intervention period
Blood pressure
Time frame: Change from baseline to after the 4 week intervention period
Fat mass
Time frame: Change from baseline to after the 4 week intervention period
waist circumference
Time frame: Change from baseline to after the 4 week intervention period
Performance test
Time frame: Change from baseline to after the 4 week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Muscle Loss
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Hansen, Lector principal investigator
Aarhus University, Department for Public Health, Section for Sport Science
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplementation, walking program and Very Low Calorie Diet in people with Muscle Loss, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Free Mass (time frame: Change from baseline to after the 4 week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.