Study to Assess the Effect of Leucine Along With Resistance Exercise on Muscle Strength and Quality of Life in Elders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ageing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L-Leucine

This arm receives a supplement of leucine along with a progressive resistance exercise program.

Group Type EXPERIMENTAL

L-leucine.

Intervention Type DIETARY_SUPPLEMENT

10 g of leucine per day, during 12 weeks.

Exercise program.

Intervention Type BEHAVIORAL

Progressive resistance exercise program 4 days a week, during 12 weeks.

Maltodextrin

This arm receives a supplement of maltodextrin along with a progressive resistance exercise program.

Group Type PLACEBO_COMPARATOR

Maltodextrin.

Intervention Type DIETARY_SUPPLEMENT

10 g of maltodextrin per day, during 12 weeks.

Exercise program.

Intervention Type BEHAVIORAL

Progressive resistance exercise program 4 days a week, during 12 weeks.

Interventions

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L-leucine.

10 g of leucine per day, during 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin.

10 g of maltodextrin per day, during 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Exercise program.

Progressive resistance exercise program 4 days a week, during 12 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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Leucine. Maxijul. Resistance exercise.

Eligibility Criteria

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Inclusion Criteria

* Over 70 years of age.
* Subjects capable of doing resistance exercise.

Exclusion Criteria

* Hospitalized patients.
* Disabled patients (i.e., not being able to exercise).
* Patients that usually train in resistance exercise.
* Patients with chronic renal failure.
* Patients with a fractured extremity during the last 6 months.
* Patients that follow diets with a protein restriction.
* Patients with oral nutritional support, enteral or parenteral nutrition.
* Patients in a low calorie diet to lose weight.
* Patients using pharmacological treatment with anorexigenic effects, anabolic steroids or corticosteroids.
* Patients with cognitive impairment or major psychiatric disorder.
* Non-signed informed consent.
* Any patient not capable to properly follow the treatment or not considered adequate by the researchers.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes