Muscle LossCMLNCT01894737
The Effect of Creatine on Muscle Loss
A study testing Creatine supplementation in people with Muscle Loss, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The primary aim of this study is to determine the effect of creatine supplementation on muscle mass loss during short-term immobilisation in healthy, young people. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss
- What is being tested?
- Creatine supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Apr 2015
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged from 18-35 years
- 18.5 < BMI < 30 kg/m2
Who cannot join
- (Family) history of thrombosis
- Smoking
- Recent surgery
- Performing regular resistance training more than once per week in the past year
- Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
- Current systemic use of corticosteroids, growth hormone, testosterone, immunosuppressants or insulin
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- All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis)
- Use of anti-coagulants
- Pre-existing renal disease or those with a potential risk for renal dysfunction (diabetes, hypertension, reduced glomerular filtration rate)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre+
Maastricht, Limburg, 6200MD
About this study
Official title: The Effect of Creatine Supplementation on Muscle Loss During Immobilisation
The primary aim of this study is to determine the effect of creatine supplementation on muscle mass loss during short-term immobilisation in healthy, young people.
Read the detailed description
Seven days of one-legged knee immobilisation in young subjects with creatine or Placebo supplementation. A randomly selected leg is immobilized for seven days. Muscle mass and strength will be determined and muscle biopsies will be collected before and immediately after immobilisation. A week after the cast is removed we will assess any differences in recovery between intervention groups.
- Conditions
- Muscle Loss
- Being tested
- Placebo supplementation, Creatine supplementation
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo supplementationOther
Seven days of one-legged knee immobilisation with placebo supplementation
Creatine supplementationOther
Seven days of one-legged knee immobilisation with creatine supplementation.
| Study group | Role | What they receive |
|---|---|---|
| immobilisation and placebo | Placebo comparator | Seven days of one-legged knee immobilisation with placebo supplementation Receives: Other: Placebo supplementation |
| immobilisation and creatine | Experimental | Seven days of one-legged knee immobilisation with creatine supplementation Receives: Other: Creatine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in quadriceps muscle cross-sectional area (CSA)
immediately before and after 1 week of immobilisation, and after 1 week recovery, quadriceps CSA will be assessed
Measured: Before and after 1 week of immobilisation, and after 1 week of recovery
Secondary outcomes (2)
change in muscle fiber type specific CSA
immediately before and after 1 week of immobilization, and after 1 week of natural recovery
Measured: Before and after 1 week of immobilisation, and after 1 week of recovery
change in muscle strength
immediately before and after 1 week of immobilization, and after 1 week of natural recovery, one-repetition maximum (1RM) muscle strength will be assessed
Measured: before and after 1 week of immobilisation, and after 1 week of recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894737
- Sponsor's protocol ID
- METC 13-3-023
- Acronym
- CML
- Status last verified
- Aug 2015
- First submitted
- 1 Jul 2013
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Backx EMP, Hangelbroek R, Snijders T, Verscheijden ML, Verdijk LB, de Groot LCPGM, van Loon LJC. Creatine Loading Does Not Preserve Muscle Mass or Strength During Leg Immobilization in Healthy, Young Males: A Randomized Controlled Trial. Sports Med. 2017 Aug;47(8):1661-1671. doi: 10.1007/s40279-016-0670-2.
PubMed 28054322Dirks ML, Backx EM, Wall BT, Verdijk LB, van Loon LJ. May bed rest cause greater muscle loss than limb immobilization? Acta Physiol (Oxf). 2016 Sep;218(1):10-2. doi: 10.1111/apha.12699. Epub 2016 May 20. No abstract available.
PubMed 27124248
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Creatine Supplementation on Muscle Loss During Immobilisation
- ClinicalTrials.gov ID
- NCT01894737
- Acronym / sponsor ID
- CML / METC 13-3-023
- Conditions
- Muscle Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Jul 2013 (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.
The primary aim of this study is to determine the effect of creatine supplementation on muscle mass loss during short-term immobilisation in healthy, young people.
Detailed description
Seven days of one-legged knee immobilisation in young subjects with creatine or Placebo supplementation. A randomly selected leg is immobilized for seven days. Muscle mass and strength will be determined and muscle biopsies will be collected before and immediately after immobilisation. A week after the cast is removed we will assess any differences in recovery between intervention groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immobilisation and placebo | Placebo comparator | Other: Placebo supplementationSeven days of one-legged knee immobilisation with placebo supplementation |
| immobilisation and creatine | Experimental | Other: Creatine supplementationSeven days of one-legged knee immobilisation with creatine supplementation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Aged from 18-35 years
- 18.5 < BMI < 30 kg/m2
Key exclusion criteria (9 listed)
- (Family) history of thrombosis
- Smoking
- Recent surgery
- Performing regular resistance training more than once per week in the past year
- Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
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 |
|---|---|---|
| Placebo supplementationSeven days of one-legged knee immobilisation with placebo supplementation | Other | immobilisation and placebo |
| Creatine supplementationSeven days of one-legged knee immobilisation with creatine supplementation. | Other | immobilisation and creatine |
Primary outcome
change in quadriceps muscle cross-sectional area (CSA)
Time frame: Before and after 1 week of immobilisation, and after 1 week of recovery
immediately before and after 1 week of immobilisation, and after 1 week recovery, quadriceps CSA will be assessed
2 secondary outcomes
change in muscle fiber type specific CSA
Time frame: Before and after 1 week of immobilisation, and after 1 week of recovery
change in muscle strength
Time frame: before and after 1 week of immobilisation, and after 1 week of recovery
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 31 Aug 2015.
- Derived from this study: PubMed 28054322Backx EMP, Hangelbroek R, Snijders T, Verscheijden ML, Verdijk LB, de Groot LCPGM, van Loon LJC. Creatine Loading Does Not Preserve Muscle Mass or Strength During Leg Immobilization in Healthy, Young Males: A Randomized Controlled Trial. Sports Med. 2017 Aug;47(8):1661-1671. doi: 10.1007/s40279-016-0670-2.
- Derived from this study: PubMed 27124248Dirks ML, Backx EM, Wall BT, Verdijk LB, van Loon LJ. May bed rest cause greater muscle loss than limb immobilization? Acta Physiol (Oxf). 2016 Sep;218(1):10-2. doi: 10.1111/apha.12699. Epub 2016 May 20. No abstract available.
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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 van Loon, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine supplementation in people with Muscle Loss, 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 9 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 31 Aug 2015. 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 quadriceps muscle cross-sectional area (CSA) (time frame: Before and after 1 week of immobilisation, and after 1 week of recovery). 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 NCT01894737, which also lists 2 linked publications.
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 31 Aug 2015.