- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01894737
The Effect of Creatine on Muscle Loss (CML)
August 28, 2015 updated by: Maastricht University Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6200MD
- Maastricht University Medical Centre+
-
-
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 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Aged from 18-35 years
- 18.5 < BMI < 30 kg/m2
Exclusion Criteria:
- (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
- 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)
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: immobilisation and placebo
Seven days of one-legged knee immobilisation with placebo supplementation
|
Seven days of one-legged knee immobilisation with placebo supplementation
|
|
Experimental: immobilisation and creatine
Seven days of one-legged knee immobilisation with creatine supplementation
|
Seven days of one-legged knee immobilisation with creatine supplementation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Before and after 1 week of immobilisation, and after 1 week of recovery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in muscle fiber type specific CSA
Time Frame: Before and after 1 week of immobilisation, and after 1 week of recovery
|
immediately before and after 1 week of immobilization, and after 1 week of natural recovery
|
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
|
immediately before and after 1 week of immobilization, and after 1 week of natural recovery, one-repetition maximum (1RM) muscle strength will be assessed
|
before and after 1 week of immobilisation, and after 1 week of recovery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Dirks 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.
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
October 1, 2013
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
July 1, 2013
First Submitted That Met QC Criteria
July 9, 2013
First Posted (Estimate)
July 10, 2013
Study Record Updates
Last Update Posted (Estimate)
August 31, 2015
Last Update Submitted That Met QC Criteria
August 28, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- METC 13-3-023
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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