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

NCT02519751 | Completed

• 1 other identifier: 202600
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sports Nutritional Sciences

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

D3 Creatine followed by creatine supplementation

EXPERIMENTAL

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.

Dietary Supplement: D3 Creatine; Dietary Supplement: Creatine

Interventions

D3 Creatine DIETARY_SUPPLEMENT

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

D3 Creatine followed by creatine supplementation

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.

D3 Creatine followed by creatine supplementation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Brentford, TW8 9 DA, United Kingdom

Location

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: August 11, 2015
• Study Start: October 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

GB (1)