Last updated: 11/03/2018 22:24:12
New method using deuterium labelled creatine to measure total body skeletal muscle mass
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Total body skeletal muscle mass estimation by creatine (methyl-d3) dilution in athletes
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Correlation between muscle mass obtained by MRI method and D3-Creatine method
Timeframe: Upto 3 months
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
20
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sports Nutritional Sciences
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2014 to January 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 40 years
Accepts healthy volunteers
Yes
- Trained and competing elite canoe athletes will be recruited, who represent Great Britain Canoeing
- Pregnant and lactating women
- Intolerance or hypersensitivity to Creatine supplementation
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2015-30-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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