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| Name | Class |
|---|---|
| Myos Corporation | UNKNOWN |
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Periods of muscle disuse are commonly experienced in young and elderly individuals as a result of short-term hospitalization or leg casting after injury. Periods of immobilization result in a profound loss of muscle mass and strength. This loss of muscle mass can have negative effects on health and the ability to carry out activities of daily living. Thus, it is very important to try to maintain muscle mass during muscle disuse. Recent research suggests that Fortetropin, which is an all-natural protein-fat complex made from fertilized hen egg yolks, can enhance muscle mass and strength with weightlifting in young men. In this study, we aim to investigate the safety and tolerability of Fortetropin and whether Fortetropin supplementation can reduce or prevent the loss of muscle mass during single-leg immobilization while you are wearing a knee brace. To make this decision, we require a study to compare Fortetropin to a placebo (something that contains the same amount of protein and energy as Fortetropin). The findings from this study will help us understand if Fortetropin supplementation is safe, tolerable, and can be used to slow muscle loss in people who undergo periods of muscle disuse (i.e. surgery, sickness).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fortetropin | Experimental | Foretetropin, which is non-thermal pasteurized, freeze-dried fertilized egg yolk, per day |
|
| Placebo | Placebo Comparator | Cheese powder, which is isonitrogenous, isoenergetic, and macronutrient-matched with Fortetropin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single leg immobilization | Other | 2 weeks of single-leg immobilization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vastus lateralis cross sectional area | Changes in vastus lateralis cross sectional area (CSA) by ultrasonography. | Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42) |
| Single fiber cross sectional area | Fiber type dependent single fiber CSA analyzed by immunohistochemistry | Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42) |
| Fat-and-bone free-mass | Fat-and-bone free-mass using DXA. | Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Myostatin level in plasma | Changes in Myostatin circulation level in plasma. | Baseline (Day 0) and Post-recovery (Day 42) |
| Leg strength | Changes in isometric muscle strength using Biodex |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise Metabolism Research Laboratory, McMaster Univeristy | Hamilton | Ontario | L8S 4K1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37220119 | Derived | Lim C, McKendry J, Giacomin T, Mcleod JC, Ng SY, Currier BS, Coletta G, Phillips SM. Fortetropin supplementation prevents the rise in circulating myostatin but not disuse-induced muscle atrophy in young men with limb immobilization: A randomized controlled trial. PLoS One. 2023 May 23;18(5):e0286222. doi: 10.1371/journal.pone.0286222. eCollection 2023. |
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| ID | Term |
|---|---|
| D020966 | Muscular Disorders, Atrophic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42) |
| Basic metabolic panel and liver enzyme | Changes in Basic metabolic panel and liver enzyme (ALT and AST) in plasma | Baseline (Day 0), post-recovery (Day 42) |
| Myostatin positive satellite cells | Changes in the number of myostatin positive satellite cells. | Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42) |
| Gastrointestinal response to ingestion of the supplement | Assessment of gastrointestinal response to ingestion of the supplement using Likert scale questionnaire. The minimum (best) value is 1 and maximum (worst) value is 10. | Pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42) |