New Method Using Deuterium Labelled Creatine to Measure Total Body Skeletal Muscle Mass

Not Applicable

Completed

• Conditions: Sports Nutritional Sciences
• Interventions: Dietary Supplement: D3 Creatine; Dietary Supplement: Creatine

• Registration Number: NCT02519751
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Creatine (methyl-d3) dilution (D3-creatine) is a novel technique for the estimation of muscle mass. The method uses a dose of deuterium-labelled creatine to determine total skeletal muscle mass via estimation of total body creatine pool size.The aim of this study is to compare estimates of total body skeletal muscle mass by D3-creatine dilution method and whole body Magnetic Resonance Imaging (MRI) in an athletic population.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-07-23
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-06
• Last Update Submitted: 2015-08-06
• Study First Posted: 2015-08-11
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Trained and competing elite canoe athletes will be recruited, who represent Great Britain Canoeing

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Exclusion Criteria

• Pregnant and lactating women
• Intolerance or hypersensitivity to Creatine supplementation
• Athletes with disabilities which affect their total body muscle mass
• If creatine was taken in a supplemented form, rather than dietary intake, more regularly than once a week within 6-weeks of assessment commencing
• Contraindication to an MRI scan

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D3 Creatine followed by creatine supplementation	D3 Creatine	Every participant will be orally administered with 60mg of D3 Creatine in a fasted state in a non-gelatin capsule. Creatine supplemented throughout the study will be administered in the following doses-0.03, 0.035, 0.04, 0.045 g.kg.Lean mass/day, increasing on weekly basis. Final dose of 0.05 g.kg.Lean mass/day is then maintained throughout the study.
D3 Creatine followed by creatine supplementation	Creatine	Every participant will be orally administered with 60mg of D3 Creatine in a fasted state in a non-gelatin capsule. Creatine supplemented throughout the study will be administered in the following doses-0.03, 0.035, 0.04, 0.045 g.kg.Lean mass/day, increasing on weekly basis. Final dose of 0.05 g.kg.Lean mass/day is then maintained throughout the study.

Primary Outcome Measures

Name	Time	Method
Correlation between muscle mass obtained by MRI method and D3-Creatine method	Upto 3 months	MRI scan of the participants will be done at Day 1 and end of study (i.e.Day 90).D3-Creatine capsule will be given orally at Day 1 and urine samples collected at 0-4h and 4-24h every day from Day 1 to Day 4.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Brentford, United Kingdom