- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06832423
CAN CREATINE SUPPLEMENTATION IMPROVE PERFORMANCE in ROCK CLIMBERS?
Why? Bouldering is a form of rock climbing that comprises short rock climbs of approximately three metres in height. Approximately 35,000 people participate in bouldering the UK, 200 of whom do so competitively. Bouldering requires a high strength to body weight ratio. Creatine is widely used in other sports as a nutritional supplement to increase muscle mass, strength and exercise tolerance. Whether Creatine can enhance performance of elite boulderers and in other disciplines of climbing is not known. Answering this question is important to identify safe and legal performance enhancing aids to enable recreational and competitive boulderers and climbers to maximise their personal and competitive potential.
What? This study will investigate a nutritional supplement, Creatine monohydrate (the "active supplement"), and compare its efficacy to a nondistinguishable and similar calorie content supplement, fructose (the "placebo"). Who? Elite boulderers from the Great Britain (GB) Bouldering Team will be invited to take part. If recruitment is slow, highly accomplished climbers from the North Wales region will also be invited.
Where? The study data collection visits will be completed at Bangor University. The supplementation will be completed by the participants at home.
How? The study will utilise a randomised placebo controlled trial design. Randomised means that participants will be allocated to receive the active supplement OR the placebo by chance. The study will last 18 weeks. Participants will visit the University for familiarisation (week 4) and again at baseline (week 0). The tests will include assessment of body weight, a whole body xray scan to determine skeletal muscle mass (at week 0 and 13 only), tests of upper body and core muscle strength, and a test of climbing-specific performance during a simulated bouldering competition.
Then, depending on group allocation, 5 g of the active supplement or placebo will be consumed four times per day for five days (the "loading phase"). Thereafter the dose will be reduced to 3 g once per day for twelve weeks (the "maintenance phase"). The supplement and the placebo will be mixed with flavoured water and consumed at meal and snack times.
Finally, at study cessation (week 13), the University visit will be repeated. The research is being funded by Bangor University. The creatinine and placebo supplements are being supplied by a nutritional company that has no influence over the publication of the results.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gwynedd
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Bangor, Gwynedd, United Kingdom, LL57 2PZ
- Bangor University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- membership of the GB Bouldering Team or climbing at grade above F6c
Exclusion Criteria:
- evident or previously diagnosed kidney damage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Creatine
5g of the active supplement (creatine monohydrate) will be consumed four times per day for five days (the "loading phase").
Thereafter the dose will be reduced to 3 g once per day for twelve weeks (the "maintenance phase").
|
Powder mixed with flavoured water
|
|
Placebo Comparator: Placebo
5g of the placebo supplement (fructose supplement providing the same calorie content as the creatine) will be consumed four times per day for five days (the "loading phase").
Thereafter the dose will be reduced to 3 g once per day for twelve weeks (the "maintenance phase").
|
Powder mixed with flavoured water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ALM
Time Frame: 12 weeks
|
Appendicular lean mass change (kg)
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- creatine01
- 15/WA/0438 (Other Identifier: Wales Research Ethics Committee 5)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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