Clinical trial NCT00929929: Study to Assess the Effect of Leucine Along With Resistance Exercise on Muscle Strength and Quality of Life in Elders
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ageing
Keywords: Aging
Functionality
Sarcopenia
Leucine
Progressive resistance exercise
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Muscle strength.
timeFrame: Baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Functionality
timeFrame: Baseline, 4 weeks, 12 weeks
Other outcomes:
measure: Quality of life
timeFrame: Baseline, 4 weeks, 12 weeks
Locations:
city: Barcelona
country: Spain
facility: Nutrition and Dietetics Unit, Hospital Clínic de Barcelona
state: Catalonia
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Maria T Forga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Joan Trabal, RD, MS
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: Pere Leyes, MD
role: STUDY_CHAIR
affiliation: University of Barcelona
name: Andreu Farran, PhD
role: STUDY_CHAIR
References:
citation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.