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Completed

NCT Number: NCT02519751

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Brentford, TW8 9 DA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

D3 Creatine

Dietary Supplement

One dose of D3 Creatine (60mg capsule) given orally on Day 1

Creatine

Dietary Supplement

Participants will consume an individual dosed level of creatine, based on their estimated muscle mass in doses of 0.03, 0.035, 0.04, 0.045 g.kg.Lean mass/day, increasing on a weekly basis. Final dose of 0.05 g.kg.Lean mass/day is then maintained throughout the study.

Primary outcomes

  1. Correlation between muscle mass obtained by MRI method and D3-Creatine method

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Total Body Skeletal Muscle Mass Estimation by Creatine (Methyl-d3) Dilution in Athletes

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2015
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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