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OpenTrials
Completed

NCT Number: NCT00929929

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

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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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Dietetics Unit, Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-leucine.

Dietary Supplement

10 g of leucine per day, during 12 weeks.

Other names: Leucine.

Maltodextrin.

Dietary Supplement

10 g of maltodextrin per day, during 12 weeks.

Other names: Maxijul.

Exercise program.

Behavioral

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

Other names: Resistance exercise.

Primary outcomes

  1. Muscle strength.

    Time frame: Baseline, 4 weeks, 12 weeks

Secondary outcomes

  1. Functionality

    Time frame: Baseline, 4 weeks, 12 weeks

Other outcomes

  1. Quality of life

    Time frame: Baseline, 4 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 30, 2009
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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