Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1, Canada
NCT Number: NCT05369026
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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Notify Me20 year–25 year
Male
Interventional
Not applicable
Hamilton, Ontario, L8S 4K1, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 weeks of single-leg immobilization
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Changes in vastus lateralis cross sectional area (CSA) by ultrasonography.
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Fiber type dependent single fiber CSA analyzed by immunohistochemistry
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Fat-and-bone free-mass using DXA.
Time frame: Baseline (Day 0) and Post-recovery (Day 42)
Changes in Myostatin circulation level in plasma.
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Changes in isometric muscle strength using Biodex
Time frame: Baseline (Day 0), post-recovery (Day 42)
Changes in Basic metabolic panel and liver enzyme (ALT and AST) in plasma
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Changes in the number of myostatin positive satellite cells.
Time frame: Pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
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.
McMaster University
Other
Effect of Fortetropin Supplementation in Young Men During Muscle Disuse
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