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| Name | Class |
|---|---|
| Lonza Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carnipure Product 1 | Experimental | Carnitine-based product 1, subjects will take one dose once daily for 56 days. |
|
| Carnipure Product 2 | Experimental | Carnitine-based product 2, subjects will take one dose once daily for 56 days. |
|
| Placebo | Placebo Comparator | Placebo, subjects will take one dose once daily for 56 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carnipure Product 1 | Dietary Supplement |
| ||
| Carnipure Product 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 2 versus Placebo | Assessed by laboratory analysis of muscle biopsy samples collected at baseline (pre-strength testing) and Day 57 (pre and post-strength testing) | Baseline and Day 57 |
| Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 versus those administered Placebo |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| Dietary Supplement |
|
| Placebo | Other | Placebo |
|
Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance). |
| 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). | 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 | Baseline and Day 57 |
| 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 | Baseline and Day 57 |
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. |
| Baseline and Day 57 |
| Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 versus those administered Carnipure Product 2 | 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. | Baseline and Day 57 |
| Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo | Lean Body Mass measured by DXA scan | Baseline and Day 57 |
| Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 | Lean Body Mass measured by DXA scan | Baseline and Day 57 |
| Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo | Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance). | Baseline to Day 57 |
| Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 | Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance). | Baseline and Day 57 |
| Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo | Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance). | Baseline and Day 57 |
| Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 | Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance). | Baseline and Day 57 |
| Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 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). | Baseline and Day 57 |
| Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 | Functional lower body strength will be assessed using the 6 Minute Walk Test to determine the distance walked over 6 minutes (metres). | Baseline and Day 57 |
| Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo | Assessed using the RAND SF-36 questionnaire | Baseline and Day 57 |
| Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 | Assessed using the RAND SF-36 questionnaire | Baseline and Day 57 |
| Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Placebo | Assessed by laboratory analysis of muscle biopsy samples collected at baseline (pre-strength testing) and Day 57 (pre and post-strength testing) | Baseline and Day 57 |
| Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Carnipure Product 2 | Assessed by laboratory analysis of muscle biopsy samples collected at baseline (pre-strength testing) and Day 57 (pre and post-strength testing) | Baseline and Day 57 |
| Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo | Blood pressure, heart rate, BMI, electrocardiogram | Screening to Day 57 |
| Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo | Blood pressure, heart rate, BMI, electrocardiogram | Screening to Day 57 |
| Changes in vital signs from screening to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 | Blood pressure, heart rate, BMI, electrocardiogram | Screening to Day 57 |
| Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo | CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin | Screening and Day 57 |
| Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo | CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin | Screening and Day 57 |
| Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 | CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin | Screening and Day 57 |
| Number of adverse events experienced in subjects administered Carnipure Product 2 versus those administered Placebo | 57 days |
| Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Placebo | 57 days |
| Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 | 57 days |