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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929929
First Posted: June 30, 2009
Last Update Posted: October 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pere Leyes, Hospital Clinic of Barcelona
  Purpose
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.

Condition Intervention
Ageing Dietary Supplement: L-leucine. Dietary Supplement: Maltodextrin. Behavioral: Exercise program.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pere Leyes, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Muscle strength. [ Time Frame: Baseline, 4 weeks, 12 weeks ]

Secondary Outcome Measures:
  • Functionality [ Time Frame: Baseline, 4 weeks, 12 weeks ]

Other Outcome Measures:
  • Quality of life [ Time Frame: Baseline, 4 weeks, 12 weeks ]

Enrollment: 30
Study Start Date: December 2009
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Leucine.
Behavioral: Exercise program.
Progressive resistance exercise program 4 days a week, during 12 weeks.
Other Name: Resistance exercise.
Placebo Comparator: Maltodextrin
This arm receives a supplement of maltodextrin along with a progressive resistance exercise program.
Dietary Supplement: Maltodextrin.
10 g of maltodextrin per day, during 12 weeks.
Other Name: Maxijul.
Behavioral: Exercise program.
Progressive resistance exercise program 4 days a week, during 12 weeks.
Other Name: Resistance exercise.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929929


Locations
Spain
Nutrition and Dietetics Unit, Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Maria T Forga, MD Hospital Clínic de Barcelona
Study Chair: Joan Trabal, RD, MS Hospital Clínic de Barcelona
Study Chair: Pere Leyes, MD Hospital Clínic de Barcelona
Study Chair: Andreu Farran, PhD University of Barcelona
  More Information

Additional Information:
Publications:
Responsible Party: Pere Leyes, Specialist, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00929929     History of Changes
Other Study ID Numbers: FRA_LEU-09
First Submitted: June 29, 2009
First Posted: June 30, 2009
Last Update Posted: October 9, 2014
Last Verified: October 2014

Keywords provided by Pere Leyes, Hospital Clinic of Barcelona:
Aging
Functionality
Sarcopenia
Leucine
Progressive resistance exercise