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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pere Leyes, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00929929
First received: June 29, 2009
Last updated: June 19, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Muscle strength. [ Time Frame: Baseline, 4 weeks, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life. [ Time Frame: Baseline, 4 weeks, 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Functionality [ Time Frame: Baseline, 4 weeks, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Universitat de 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
Study First Received: June 29, 2009
Last Updated: June 19, 2013
Health Authority: Spain: Ministry of Health

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

ClinicalTrials.gov processed this record on August 01, 2014