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Drug manufacturing update. Study site will proceed with study in future.
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This study is being done to gather data on whether oral supplementation of CoQ10 is enriched in the blood and muscles in older adults with sarcopenia. This study involves 28 consecutive days of oral CoQ10 supplementation to explore changes in muscle strength, aerobic capacity and physical function with CoQ10 supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older adults with sarcopenia (placebo) | Placebo Comparator |
| |
| Older adults with sarcopenia (drug) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPM31510 | Drug | A total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of skeletal muscle | We will evaluate changes in mitochondrial function (respiration) on permeabilized skeletal muscle fiber bundles obtained from biopsies of the vastus lateralis and blood draws, respectively. Blood and muscle biospecimens will also be obtained for multi-omics analysis. | Following 28 days of treatment |
| Measurement of platelet CoQ10 level | We will evaluate changes in mitochondrial function (respiration) on cells (platelets) obtained from biopsies of the vastus lateralis and blood draws, respectively. Blood and muscle biospecimens will also be obtained for multi-omics analysis. | Following 28 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Coen, PhD | AdventHealth Translational Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Translational Research Institute | Orlando | Florida | 32804 | United States |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Randomized, parallel arm trial in which the supplementation with oral BPM 31510 or placebo will be blind.
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Randomized, parallel arm trial in which the supplementation with oral BPM 31510 or placebo will be blind.
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| Placebo | Other | A total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime. |
|
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |