This study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects.
This is a randomised, double-blind study of the effects of creatine supplementation on muscle energetics and cognitive function, using 31P-MRS and fMRI. 31P-MRS data will be acquired continuously during exercise phase and in the post-exercise metabolic recovery phase. Participants will undergo a fMRI scan of the brain to record changes in the blood oxygen level dependent (BOLD) signal during a series of cognitive tests. In addition, participants will undergo a resting state BOLD scan and a structural MRI scan for localization of brain regions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
30
GSK Investigational Site
London, United Kingdom
PCr Concentration (at rest)
Change in PCr concentration (at rest), as measured by 31P- MRS on the calf. Static MRS will be acquired at rest up to 2 min.
Time frame: Baseline to Day 3, 7 and 14
PCr concentration during recovery
Change in PCr concentration (during recovery) as measured by 31P- MRS on the calf. Dynamic MRS will be acquired with the patient at rest for up to 20 min.
Time frame: Baseline to Day 3, 7, and 14
Change in PCr from rest to recovery
Change in PCr concentration (from rest to recovery) as measured by 31P- MRS on the calf.
Time frame: Baseline to Day 3, 7, and 14
PCr recovery rate (PCr(T1/2))
Measured by 31P-MRS on the leg
Time frame: Baseline to Day 3, 7 and 14
ADP recovery rate (ADP (T1/2))
Measured by 31P-MRS on the leg
Time frame: Baseline to Day 3, 7 and 14
pH at the end of pedal test, or at the time of voluntary cessation (Post-pedal test pH)
Measured by 31P-MRS on the leg
Time frame: Baseline to Day 3, 7 and 14
Lowest pH measured during pedal test or recovery (Minimum pH)
Measured by 31P-MRS on the leg
Time frame: Baseline to Day 3, 7 and 14
BOLD signal in the brain
Change in BOLD signal, as measured by an fMRI scan of the brain. Data may be examined at both a whole-brain and region of interest (ROI) level, with ROIs defined either anatomically or based on clusters derived from the group data.
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Time frame: Baseline to Day 14
Cognitive function
A standard test battery will be used to examine changes in behavioural measures of cognition, including speed of processing (detection task), attention/vigilance (identification task), working memory, visual learning and memory, and reasoning and problem solving. In addition, a visual analogue scales (VAS) will be used to assess subjective mood state.
Time frame: Baseline to Day 14