NCT05369026

Effect of a Natural Source Supplementation on Muscle Mass

Completed NA Last updated 11 May 2022

What this trial tests

NA trial testing Single leg immobilization in Muscle Disuse Atrophy in 24 participants. Completed in 25 March 2022.

Timeline

1 January 2020

Primary endpoint
25 March 2022

25 March 2022

Quick facts

Lead sponsor	McMaster University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	24
Start date	1 January 2020
Primary completion	25 March 2022
Estimated completion	25 March 2022
Sites	1 location across Canada

Drugs / interventions tested

• Single leg immobilization

Conditions studied

• Muscle Disuse Atrophy — all drugs for Muscle Disuse Atrophy →
• Nutrition, Healthy — all drugs for Nutrition, Healthy →

Sponsor

McMaster University

Who can join

Adults 20 to 25, male only, with Muscle Disuse Atrophy or Nutrition, Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Fortetropin supplementation prevents the rise in circulating myostatin but not disuse-induced muscle atrophy in young men with limb immobilization: A randomized controlled trial.
   Lim C, McKendry J, Giacomin T, Mcleod JC, et al · · 2023 · cited 1× · PMID 37220119 · DOI 10.1371/journal.pone.0286222