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The primary objective of this trial is to evaluate the effect of oral administration of an Astaxanthin formulation compared to placebo after one month alone and after an additional 3 months of exercise training on mitochondrial and skeletal muscle function in elderly subjects with evidence of mitochondrial dysfunction/sarcopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Astaxanthin and exercise | Experimental | Astaxanthin formulation intake for one month followed by a 3-month exercise training program with astaxanthin formulation intake. |
|
| Placebo and exercise | Placebo Comparator | Placebo intake for one month followed by 3-month exercise training with placebo intake. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astaxanthin formulation | Other | Astaxanthin formulation containing AstaReal® astaxanthin (Haematococcus pluvialis algae extract), tocotrienol, and zinc will be orally administered starting on Day 1 until Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal muscle strength and performance measured by 31P-magnetic resonance spectroscopy (31p MRS) | Skeletal muscle strength and performance will be evaluated by changes from baseline in muscle work rate calculated from the results of the leg muscle fatigue protocol testing: Baseline-Day 30-Day 120. | Day 30 - Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle energetics | Muscle energetics and size measured by 31p MRS: Baseline | Day 30-Day 120 |
| Hand grip strength | Hand grip strength | Day 30-Day120 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center Prevention Center | Seattle | Washington | 98109 | United States | ||
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Parallel assignment
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|
| Placebo | Other | Placebo will be orally administered starting on Day 1 until Day 120. |
|
| Exercise training | Other | The subjects will undergo interval treadmill incline protocol (target 85% HR max, 3 times a week for 40 to 60 minutes) starting on Day 31 until Day 120. |
|
| 6-minute walk test | 6-minute walk test | Day 30-Day 120 |
| Safety Measures | Safety as assessed by measures such as adverse events | Baseline-Day 30-Day 120 |
| University of Washington Medical Center |
| Seattle |
| Washington |
| 98195 |
| United States |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |