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

October 8, 2014 updated by: Pere Leyes, Hospital Clinic of Barcelona

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Nutrition and Dietetics Unit, Hospital Clínic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-Leucine
This arm receives a supplement of leucine along with a progressive resistance exercise program.
Dietary supplement: L-leucine.
10 g of leucine per day, during 12 weeks.
Other Names:
  • Leucine.
Behavioral: Exercise program.
Progressive resistance exercise program 4 days a week, during 12 weeks.
Other Names:
  • Resistance exercise.
Placebo Comparator: Maltodextrin
This arm receives a supplement of maltodextrin along with a progressive resistance exercise program.
Behavioral: Exercise program.
Progressive resistance exercise program 4 days a week, during 12 weeks.
Other Names:
  • Resistance exercise.
Dietary supplement: Maltodextrin.
10 g of maltodextrin per day, during 12 weeks.
Other Names:
  • Maxijul.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle strength.
Time Frame: Baseline, 4 weeks, 12 weeks
Baseline, 4 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Functionality
Time Frame: Baseline, 4 weeks, 12 weeks
Baseline, 4 weeks, 12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: Baseline, 4 weeks, 12 weeks
Baseline, 4 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Maria T Forga, MD, Hospital Clinic of Barcelona
  • Study Chair: Joan Trabal, RD, MS, Hospital Clinic of Barcelona
  • Study Chair: Pere Leyes, MD, Hospital Clinic of Barcelona
  • Study Chair: Andreu Farran, PhD, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimate)

June 30, 2009

Study Record Updates

Last Update Posted (Estimate)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FRA_LEU-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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