NCT06832423

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
Last Updated

February 18, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

February 13, 2025

Last Update Submit

February 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • ALM

    Appendicular lean mass change (kg)

    12 weeks

Study Arms (2)

Creatine

EXPERIMENTAL

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").

Dietary Supplement: Creatine monohydrate

Placebo

PLACEBO COMPARATOR

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").

Dietary Supplement: Placebo

Interventions

Creatine monohydrateDIETARY_SUPPLEMENT

Powder mixed with flavoured water

Creatine
PlaceboDIETARY_SUPPLEMENT

Powder mixed with flavoured water

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • membership of the GB Bouldering Team or climbing at grade above F6c

You may not qualify if:

  • evident or previously diagnosed kidney damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangor University

Bangor, Gwynedd, LL57 2PZ, United Kingdom

Location

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 18, 2025

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

February 18, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations