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A randomized, double-blind, placebo-controlled, parallel study to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance. Treatments compared will be β-hydroxymethylbutyrate (β-HMB) with a resistance training program or placebo with a resistance training program.
Sarcopenia is a geriatric syndrome characterized by the loss of skeletal muscle mass and strength that occurs with advancing age; it is related to frailty, falls, worsening quality of life, and death in chronic and elderly patients. Diagnosis of sarcopenia is based on clinical criteria: presence of low muscle mass and the presence of low muscle function and/or low physical performance. The latest developments indicate that dietary supplementation combined with resistance exercise could be an option to improve muscle mass and function.
The objective of the study is to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance.
Design: A randomized, double-blind, placebo-controlled, parallel study with two intervention groups. The investigators shall compare placebo against an intervention with β-HMB in patients performing a resistance training program after an acute process (post-acute period) during 12 weeks. There will be 16 patients in each arm of the study. Additionally a one year follow up visit will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| β-hydroxymethylbutyrate | Experimental | β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program |
|
| Placebo | Placebo Comparator | Maltodextrin 3 grams once a day combined with a resistance training program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| β-hydroxymethylbutyrate | Dietary Supplement | β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline handgrip strength at 12 weeks | Handgrip strength will be measured by a hand-held dynamometer (JAMAR®, Nottinghamshire, UK) and expressed in Kg | From baseline till 12 weeks |
| Change from baseline physical performance-gait speed- at 12 weeks | Physical performance will be assessed with gait speed in the 4-m walk test | From baseline till 12 weeks |
| Change from baseline physical performance-SPPB- at 12 weeks | Physical performance will be assessed with gait speed in short physical performance battery | From baseline till 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospital readmissions | Admissions in acute care due to medical health issues | From baseline till 12 weeks |
| Change from baseline functional status at 12 weeks | Functional status assessed by the Barthel index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Dolores Sánchez-Rodríguez, PhD, MD | Parc de Salut Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de l'Esperanza | Barcelona | 09024 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27823730 | Background | Sanchez-Rodriguez D, Marco E, Ronquillo-Moreno N, Miralles R, Mojal S, Vazquez-Ibar O, Escalada F, Muniesa JM. The PSSMAR study. Postacute sarcopenia: Supplementation with beta-hydroxyMethylbutyrate after resistance training: Study protocol of a randomized, double-blind controlled trial. Maturitas. 2016 Dec;94:117-124. doi: 10.1016/j.maturitas.2016.08.019. Epub 2016 Sep 9. No abstract available. | |
| 32737844 |
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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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| Placebo | Dietary Supplement | Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks |
|
| From baseline till 12 weeks |
| Absolute functional gain in 12 weeks | Absolute functional gain measured with Barthel scale | From baseline till 12 weeks |
| Relative functional gain in 12 weeks | Relative functional gain measured with Barthel scale | From baseline till 12 weeks |
| Change from baseline rehabilitation impact indices at 12 weeks | Rehabilitation Efficiency Index | From baseline till 12 weeks |
| Number of adverse events | Adverse events will be collected by medical interview during the study | From baseline till 12 weeks |
| Change from baseline lean and fat body mass (muscle mass) at 12 weeks | Lean and fat body mass will be measured by electrical impedance measured in kg and expressed as normal, low or high values according to normality values for the European population | From baseline till 12 weeks |
| Background |
| Reginster JY, Beaudart C, Al-Daghri N, Avouac B, Bauer J, Bere N, Bruyere O, Cerreta F, Cesari M, Rosa MM, Cooper C, Cruz Jentoft AJ, Dennison E, Geerinck A, Gielen E, Landi F, Laslop A, Maggi S, Prieto Yerro MC, Rizzoli R, Sundseth H, Sieber C, Trombetti A, Vellas B, Veronese N, Visser M, Vlaskovska M, Fielding RA. Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults. Aging Clin Exp Res. 2021 Jan;33(1):3-17. doi: 10.1007/s40520-020-01663-4. Epub 2020 Jul 31. |
| 26051706 | Background | Sanchez-Rodriguez D, Marco E, Miralles R, Guillen-Sola A, Vazquez-Ibar O, Escalada F, Muniesa JM. Does gait speed contribute to sarcopenia case-finding in a postacute rehabilitation setting? Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):176-81. doi: 10.1016/j.archger.2015.05.008. Epub 2015 May 29. |
| 24726179 | Background | Sanchez-Rodriguez D, Marco E, Miralles R, Fayos M, Mojal S, Alvarado M, Vazquez-Ibar O, Escalada F, Muniesa JM. Sarcopenia, physical rehabilitation and functional outcomes of patients in a subacute geriatric care unit. Arch Gerontol Geriatr. 2014 Jul-Aug;59(1):39-43. doi: 10.1016/j.archger.2014.02.009. Epub 2014 Mar 1. |
| 31789867 | Background | Sanchez-Rodriguez D, Marco E, Cruz-Jentoft AJ. Defining sarcopenia: some caveats and challenges. Curr Opin Clin Nutr Metab Care. 2020 Mar;23(2):127-132. doi: 10.1097/MCO.0000000000000621. |
| 30312372 | Background | Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. |
| 31233072 | Background | Sanchez-Rodriguez D, Marco E, Davalos-Yerovi V, Lopez-Escobar J, Messaggi-Sartor M, Barrera C, Ronquillo-Moreno N, Vazquez-Ibar O, Calle A, Inzitari M, Piotrowicz K, Duran X, Escalada F, Muniesa JM, Duarte E. Translation and Validation of the Spanish Version of the SARC-F Questionnaire to Assess Sarcopenia in Older People. J Nutr Health Aging. 2019;23(6):518-524. doi: 10.1007/s12603-019-1204-z. |
| 38171034 | Derived | Meza-Valderrama D, Sanchez-Rodriguez D, Messaggi-Sartor M, Munoz-Redondo E, Morgado-Perez A, Tejero-Sanchez M, De Jaime-Gil E, Leiva-Banuelos N, Marco E. Supplementation with beta-hydroxy-beta-methylbutyrate after resistance training in post-acute care patients with sarcopenia: A randomized, double-blind placebo-controlled trial. Arch Gerontol Geriatr. 2024 Apr;119:105323. doi: 10.1016/j.archger.2023.105323. Epub 2023 Dec 27. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |