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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-Leucine | Experimental | This arm receives a supplement of leucine along with a progressive resistance exercise program. |
|
| Maltodextrin | Placebo Comparator | This arm receives a supplement of maltodextrin along with a progressive resistance exercise program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-leucine. | Dietary Supplement | 10 g of leucine per day, during 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength. | Baseline, 4 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functionality | Baseline, 4 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Baseline, 4 weeks, 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria T Forga, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Joan Trabal, RD, MS | Hospital Clinic of Barcelona | Study Chair |
| Pere Leyes, MD | Hospital Clinic of Barcelona | Study Chair |
| Andreu Farran, PhD | University of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrition and Dietetics Unit, Hospital ClÃnic de Barcelona | Barcelona | Catalonia | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11253156 | Background | 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. |
| Label | URL |
|---|---|
| A brief definition of the Frailty Syndrome. | View source |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007930 | Leucine |
| C008315 | maltodextrin |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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| Maltodextrin. | Dietary Supplement | 10 g of maltodextrin per day, during 12 weeks. |
|
|
| Exercise program. | Behavioral | Progressive resistance exercise program 4 days a week, during 12 weeks. |
|
|
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |