Ageing Clinical Trial
Official title:
Randomized Double-blind, Placebo-controlled, Parallel Design, Pilot Study to Assess the Effect of a Nutritional Supplement With Leucine, Along With a Progressive Resistance Exercise Program, on Muscle Strength and Quality of Life in Elderly People.
The purpose of this study is to determine whether a nutritional supplement with an amino acid called leucine along with resistance exercise are effective in the improvement of muscle strength and quality of life in elderly people.
Physiological aging is accompanied by functional loss and changes in different organs,
including the skeletal muscle, with a progressive reduction in muscle mass. This is called
physiological sarcopenia of the elderly.
In any population of autonomous individuals over 65 years, a proportion between 3% and 32%
depending on age, meets the criteria of the so-called Frailty Syndrome. Frailty is
characterized by a decrease in reserves and resistance to aggression, conferring increased
vulnerability, disability and poor vital prognosis.
A feature of the Frailty Syndrome is the potential reversibility of many of the elements at
the initial stages of frailty. Currently, available treatment for frailty is limited. One of
the tools should be the prevention of sarcopenia, where nutritional treatment and exercise
have a vital role.
Protein synthesis in aged muscle can be improved by increasing leucine concentration above
physiological levels by a higher intake. Regarding exercise, progressive resistance training
is one of the interventions that have shown better results in the increase of mass and
muscle strength in elderly people.
The hypothesis raises the possibility that an intervention consisting of a leucine
supplement along with progressive resistance training, is superior to the same training
program and a placebo in improving muscle strength and quality of life in elderly people.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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