New Method Using Deuterium Labelled Creatine to Measure Total Body Skeletal Muscle Mass
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|ClinicalTrials.gov Identifier: NCT02519751|
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : August 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sports Nutritional Sciences||Dietary Supplement: D3 Creatine Dietary Supplement: Creatine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Total Body Skeletal Muscle Mass Estimation by Creatine (Methyl-d3) Dilution in Athletes|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: 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.
Dietary Supplement: D3 Creatine
One dose of D3 Creatine (60mg capsule) given orally on Day 1
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519751
|GSK Investigational Site|
|Brentford, United Kingdom, TW8 9 DA|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|