Immunotec receives NHPD/Health Canada authorization to begin a study on the effect of the cysteine-rich whey protein isolate (immunocal) in combination with physical exercise on muscle function, body composition and inflammatory cytokine levels in elderly persons: a randomized, double-blind study.
Immunotec Inc. has announced that the Natural Health Products Directorate (NHPD) - a division of Health Canada responsible for evaluating the safety, efficacy and quality of natural health products (NHPs) - granted authorization for Immunotec to conduct a clinical trial of IMMUNOCAL in elderly persons.
Aging is typically associated with a decrease in skeletal muscle mass and muscle function, which contributes decisively to disability in old age and to a loss of quality of life.
Resistance training exercise can increase muscle strength, function and mass in older adults.
The primary aim of this study is to determine whether taking a cysteine-rich whey protein isolate (IMMUNOCAL) compared to casein (a milk protein used as control, which contains little cysteine) may optimize the quality of life in the elderly.
The consumption of these proteins will be evaluated in association with resistance training to determine if the combination of Immunocal with exercise will provide significant gains in muscle strength, muscle mass and cognitive functions, compared to the same training program combined with taking casein, the control protein.
Benefits in these fields can be translated to improved quality of life for elderly persons.
The Principal Investigator, Dr. Remi Rabasa-Lhoret, MD, PhD, Associate Research Professor and Metabolic Unit Laboratory Director, Institut de recherches cliniques de Montreal (IRCM) and his research team are very enthusiastic about the prospects of the trial.
"Immunotec should be commended for initiating and supporting this very important research study of its lead product "Immunocal" in aging. It is rare to see companies in this field conducting double blind randomized studies with a control group. The focus of the study is highly relevant for people over the age of 65. Assessing the combined effects of exercise and supplementation with cysteine-rich whey protein isolate (IMMUNOCAL) as well as the potential impact on important functions, such as muscle strength and cognition may provide significant benefits," said Dr. Rabasa-Lhoret.
"NHPD, Health Canada's clearance of the clinical application for our Immunocal trial adds to our significant accomplishments and continued commitment in research," said Mr. James Northrop, President and CEO of Immunotec Inc.
"This marks the first, controlled clinical study of Immunocal in an elderly population. Furthermore, we are delighted with the fact that this study will be run at IRCM - a research center in the province of Quebec with an excellent reputation in Canada and internationally."
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