Ageing Clinical Trial
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.
Verified date | October 2014 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Nutrition and Dietetics Unit, Hospital Clínic de Barcelona | Barcelona | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Spain,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life | Baseline, 4 weeks, 12 weeks | No | |
Primary | Muscle strength. | Baseline, 4 weeks, 12 weeks | No | |
Secondary | Functionality | Baseline, 4 weeks, 12 weeks | No |
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