Disuse AtrophyIM-PRONCT01588808
Immobilization and Protein Supplementation (IM-PRO)
A study testing Immobilization in people with Disuse Atrophy and Aging, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In the present study, the effects of 5 days of lower limb immobilization with or without twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be determined. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Disuse Atrophy, Aging
- What is being tested?
- Immobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Feb 2013
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Aged from 18-35 years and from 65-75 years
- 18.5 < BMI < 30 kg/m2
Who cannot join
- Smoking
- Performing regular resistance training in the previous 6 months
- Hypertension (according to WHO criteria) [52] and/or cardiovascular disease
- Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
- Systemic use of antibiotics within 3 weeks prior to the study visit
- Current systemic use of corticosteroids, growth hormone, testosterone, immunosuppressants or insulin
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- Type 2 diabetes mellitus
- Any history of thrombosis
- Any family history (1st grade) of thrombosis
- All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
- Myocardial infarction within the last 3 years
- Use of anti-coagulants
- Any (history of) gastrointestinal disease that interferes with GI function
- Indications related to interaction with the study product:
- Known allergy to milk or milk products
- Known galactosemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Dietary Protein Supplementation and Age on Muscle Mass Loss During Short Term One-legged Knee Immobilization
In the present study, the effects of 5 days of lower limb immobilization with or without twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be determined. A young group will be included to compare the changes in muscle mass and muscle fiber characteristics between young and old men.
- Conditions
- Disuse Atrophy, Aging
- Being tested
- Immobilization
- Keywords
- Immobilization, Protein supplementation
- Medical subject headings
- Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmobilizationBehavioural
Immobilization with protein (elderlY), immobilization without protein (elderly and young)
| Study group | Role | What they receive |
|---|---|---|
| Immobilization with protein (elderly) | Active comparator | Immobilization with twice-daily protein supplementation - in the elderly Receives: Behavioral: Immobilization |
| Immobilization without protein (elderly) | Placebo comparator | Immobilization without twice-daily protein supplementation - in the elderly Receives: Behavioral: Immobilization |
| Immobilization without protein (young) | Active comparator | Immobilization without twice-daily protein supplementation - in the young Receives: Behavioral: Immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass
Measured: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Change in muscle fiber size
Measured: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Secondary outcomes (1)
Change in muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension
Measured: Three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disuse AtrophyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lex Verdijk, Maastricht University Medical Center
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588808
- Sponsor's protocol ID
- MEC 12-3-012
- Acronym
- IM-PRO
- Status last verified
- Jul 2013
- First submitted
- 26 Apr 2012
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dirks ML, Wall BT, Nilwik R, Weerts DH, Verdijk LB, van Loon LJ. Skeletal muscle disuse atrophy is not attenuated by dietary protein supplementation in healthy older men. J Nutr. 2014 Aug;144(8):1196-203. doi: 10.3945/jn.114.194217. Epub 2014 Jun 11.
PubMed 24919692
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Protein Supplementation and Age on Muscle Mass Loss During Short Term One-legged Knee Immobilization
- ClinicalTrials.gov ID
- NCT01588808
- Acronym / sponsor ID
- IM-PRO / MEC 12-3-012
- Conditions
- Disuse Atrophy, Aging
- Keywords
- Immobilization, Protein supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 May 2012 (estimated)
- 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 the present study, the effects of 5 days of lower limb immobilization with or without twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be determined. A young group will be included to compare the changes in muscle mass and muscle fiber characteristics between young and old men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immobilization with protein (elderly) | Active comparator | Behavioral: ImmobilizationImmobilization with twice-daily protein supplementation - in the elderly |
| Immobilization without protein (elderly) | Placebo comparator | Behavioral: ImmobilizationImmobilization without twice-daily protein supplementation - in the elderly |
| Immobilization without protein (young) | Active comparator | Behavioral: ImmobilizationImmobilization without twice-daily protein supplementation - in the young |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- Aged from 18-35 years and from 65-75 years
- 18.5 < BMI < 30 kg/m2
Key exclusion criteria (16 listed)
- Smoking
- Performing regular resistance training in the previous 6 months
- Hypertension (according to WHO criteria) [52] and/or cardiovascular disease
- Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
- Systemic use of antibiotics within 3 weeks prior to the study visit
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 |
|---|---|---|
| ImmobilizationImmobilization with protein (elderlY), immobilization without protein (elderly and young) | Behavioural | Immobilization with protein (elderly), Immobilization without protein (elderly), Immobilization without protein (young) |
Primary outcome
Change in muscle mass
Time frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Change in muscle fiber size
Time frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
1 secondary outcome
Change in muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension
Time frame: Three days before immobilization, and directly after immobilization (day of cast removal; day 6)
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 10 Jul 2013.
- Derived from this study: PubMed 24919692Dirks ML, Wall BT, Nilwik R, Weerts DH, Verdijk LB, van Loon LJ. Skeletal muscle disuse atrophy is not attenuated by dietary protein supplementation in healthy older men. J Nutr. 2014 Aug;144(8):1196-203. doi: 10.3945/jn.114.194217. Epub 2014 Jun 11.
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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.
Luc JC van Loon, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immobilization in people with Disuse Atrophy and Aging, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 16 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 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in muscle mass (time frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588808, which also lists 1 linked publication.
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 10 Jul 2013.