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

Sports Nutritional Sciences Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519751
• Other study ID #: 202600
• Status: Completed
• Phase: N/A
• First received: July 23, 2015
• Last updated: August 6, 2015
• Start date: October 2014
• Est. completion date: January 2015

Study information

• Verified date: August 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sports Nutritional Sciences

Intervention

Dietary Supplement:
• D3 Creatine
One dose of D3 Creatine (60mg capsule) given orally on Day 1
• Creatine
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.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Brentford

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between muscle mass obtained by MRI method and D3-Creatine method	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.	Upto 3 months	No