This study evaluates two L-Carnitine-based products on muscle function in healthy older adults (55 to 70 years old). These products are suspected to improve muscle function and possibly promote building of muscle mass. One third of the subjects will be on Carnipure Product 1, one third will be on Carnipure Product 2 and one third will be on placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
42
KGK Synergize Inc.
London, Ontario, Canada
Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 2 versus those administered Placebo
A composite endpoint determined by multiplying the values of Lean Body Mass (as assessed by DXA, kg), and functional muscle strength (as assessed by 6 Minute Walk Test, metres; Lower Body Dynamometry, kg; Upper Body Dynamometry, kg). Percent change from baseline to day 57 will be derived.
Time frame: Baseline and Day 57
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance).
Time frame: Baseline and Day 57
Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance).
Time frame: Baseline and Day 57
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Functional lower body strength will be assessed using the 6 Minute Walk Test to determine the distance walked over 6 minutes (metres).
Time frame: Baseline and Day 57
Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Assessed using the RAND SF-36 questionnaire
Time frame: Baseline and Day 57
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Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Lean Body Mass measured by DXA scan
Time frame: Baseline and Day 57