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

NCT ID: NCT02519751

Last Updated: 2015-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Sports Nutritional Sciences

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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D3 Creatine followed by creatine supplementation

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.

Group Type EXPERIMENTAL

D3 Creatine

Intervention Type DIETARY_SUPPLEMENT

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

Creatine

Intervention Type 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.

Interventions

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D3 Creatine

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Brentford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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202600

Identifier Type: -

Identifier Source: org_study_id

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