CEDAR KNOLLS, N.J.—MYOS RENS Technology Inc., an advanced nutrition company, has entered into a research agreement with the department of Kinesiology at McMaster University in Hamilton, Canada. The study will examine the impact of Fortetropin on reducing muscle disuse atrophy in young men. Muscle atrophy due to disuse commonly occurs in response to immobilization, such as the atrophy of the thigh muscles following a period of casting for fracture or following surgery such as knee replacement.
The principal investigator for this clinical study will be Stuart M. Phillips, Ph.D., professor of Kinesiology, Canada Research Chair and director of the Physical Activity Centre of Excellence (PACE) at McMaster University. He will supervise an interdisciplinary team of scientists and physicians. Phillips is a key opinion leader in the field of muscle physiology and sarcopenia, with over 200 peer-reviewed publications to his credit.
In this randomized, double-blind, placebo-controlled clinical study, 24 male subjects will consume either Fortetropin or a macronutrient-matched placebo for 6 weeks. After a 2-week Fortetropin pre-treatment phase, subjects will wear a knee brace for a period of 2 weeks in order to simulate immobilization-induced muscle disuse atrophy. Following the immobilization phase, subjects will remove the knee brace while continuing to consume Fortetropin for an additional 2 weeks (recovery phase).
In order to assess the impact of Fortetropin on muscle atrophy, a series of body composition measurements will be performed during each phase of the study. Muscle biopsy samples will be collected during each phase, and in-depth biochemical analyses will be performed.
“MYOS aims to become one of the leading medical nutrition companies in the area of muscle recovery and rehabilitation. Encouraged by promising results from multiple human and canine clinical studies, we are delighted to work with the respected research group of Professor Phillips at McMaster University,” said Joseph Mannello, CEO of MYOS. “Completing this study is an important part of our commercial strategy to increase our business in a growing market with tremendous opportunity.”
Fortetropin is a proprietary bioactive composition made from fertilized egg yolk. It has the potential to improve muscle health, based on multiple rigorous studies in both canines and humans. This new study will build upon previous research which demonstrated that Fortetropin minimizes muscle atrophy in dogs recovering from leg ligament repair surgery.
“We are excited to work with MYOS on this human clinical trial. Very few nutrition products have been studied to this degree,” added Phillips.
Fortetropin has also been clinically shown to increase muscle size, lean body mass and strength as part of resistance training, and to increase the fractional synthetic rate (FSR) of muscle proteins in older men and women (60-75 years of age). Back in June, MYOS announced positive top-line results from a study conducted at the University of California, Berkeley (UC Berkeley) and the University of Arkansas for Medical Sciences evaluating the impact of Fortetropin on the rate of muscle protein synthesis in older men and women.
In this randomized, double-blind, placebo-controlled clinical study, 20 subjects were assigned to consume either Fortetropin or a placebo for 21 days, along with daily doses of a heavy water tracer. After 21 days, a microbiopsy was collected from each subject and analyzed to determine the FSR of muscle proteins.
For subjects who received Fortetropin, the average FSR in several gene ontologies were significantly higher, compared to the placebo group. The proportion of proteins with an increased FSR in the Fortetropin group (33/38 myofibril proteins, 36/44 cytoplasmic proteins and 15/19 mitochondrial proteins) relative to the placebo group was statistically significant.
“The results from this clinical study evaluating the impact of Fortetropin on muscle protein synthesis rates in older adults are very exciting. Fortetropin clearly has a robust effect on the rate of muscle protein synthesis in older adults. It is rare for a nutrition product to show such a consistent and positive effect. We look forward to continued scientific collaboration with MYOS,” commented principal investigator, William J. Evans, Ph.D., adjunct professor of Human Nutrition at UC Berkeley.
Sarcopenia is commonly observed in many older adults, and is characterized by a decrease in the rate of muscle protein synthesis. Low muscle mass is associated with fall-related injuries which can be devastating to adults over the age of 60 years, particularly if they result in a bone fracture. There are limited options available to address age-related muscle loss. Geriatricians commonly manage this through lifestyle interventions like diet and exercise.
In this study, Fortetropin was shown to improve the average muscle protein synthesis rate, providing the potential to improve muscle health among older adults.
“We believe the results from the UC Berkeley clinical study show that our all-natural ingredient Fortetropin can significantly improve muscle health for older adults,” noted Mannello in a press release. “We are committed to continuing scientific research to demonstrate the efficacy of our advanced nutrition products. This study shows Fortetropin's remarkable potential for managing age-related muscle loss in older adults. The results from this study will form the cornerstone of MYOS’ ‘Healthy Aging’ business unit. We plan to aggressively move forward with additional clinical studies that will focus on this area along with recovery and rehabilitation.”
