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| Name | Class |
|---|---|
| Axcella Health, Inc | INDUSTRY |
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This is a safety and tolerability study investigating the effect of an amino acid formulation in healthy volunteers during and after limb immobilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino Acid | Experimental | Subjects in this arm will receive amino acid supplementation (23.7g) 3 times daily for 28 days. Amino acids will be provided in powder form to be dissolved in 8oz of water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period. |
|
| Placebo | Placebo Comparator | Subjects in this arm will receive placebo 3 times daily for 28 days. Placebo will consist of 23.7g of excipient-matched placebo in water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino Acid | Dietary Supplement | 23.7 g amino acid 3 times daily for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle atrophy | To determine the impact of an amino acid formulation on muscle atrophy after 7 days of amino acid supplementation followed by 7 days of single leg immobilization and 14 days of recovery post-immobilization muscle atrophy will be assessed utilizing percutaneous muscle biopsy to quantify fibre size in the vastus lateralis. | day 0, day 8, day 15 and day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle strength | Strength will be measured using a Biodex. | day 0, day 8, day 15 and day 28 |
| Change in muscle size | Muscle size will be assessed via MRI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart M Phillips, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Univeristy | Hamilton | Ontario | L8S4K1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31355205 | Derived | Holloway TM, McGlory C, McKellar S, Morgan A, Hamill M, Afeyan R, Comb W, Confer S, Zhao P, Hinton M, Kubassova O, Chakravarthy MV, Phillips SM. A Novel Amino Acid Composition Ameliorates Short-Term Muscle Disuse Atrophy in Healthy Young Men. Front Nutr. 2019 Jul 10;6:105. doi: 10.3389/fnut.2019.00105. eCollection 2019. |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D000596 | Amino Acids |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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2 groups of 10 each will be randomized to receive amino acid supplementation or placebo for 28 days during which they will have one leg immobilized by a removable brace.
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Sachets with the supplement will be blinded to the participant, and research assistants. Outcomes assessors will be blinded to condition as well.
| Breg Brace single-leg immobilization |
| Device |
7 days of single leg immobilization; randomized to leg; knee brace will be worn in a fixed flexion position at 140°. |
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| Placebo | Other | Excipient-matched placebo 3 times daily for 28 days |
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| day 0, day 8, day 15 and day 28 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |