Clinical trial NCT02679742: Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training
Official title: The PSSMAR Study (Postacute Sarcopenia, Supplementation With β-hydroxyMethylbutyrate After Resistance Training)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: beta hydroxy beta methylbutyrate
older people
muscle mass
muscle strength
post-acute
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* male or female ≥60 years old
* sarcopenia diagnosis and case-finding criteria following European Working Group On Sarcopenia in Older People (EWGSOP)
* being discharged from post-acute care geriatric unit for rehabilitation treatment
* ambulatory prior to the recent acute process
* cognitive situation that let them to understand and follow an active physical rehabilitation program (Mini-Mental Status Examination ≥21/30)
* voluntary participation and being able and willing to provide an informed consent

Exclusion Criteria:

* potential participants will be excluded if they have active malignancy (exception basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix)
* major lower limb surgery over the past 6 months (knee or hip arthroplasty)
* contraindication for resistance training
* performed regular exercise in the last 6 months
* use of any medications interfering with the nutritional intervention
* serious clinical conditions that compromises and endanger the patient's life
* contraindication, intolerance or allergy to β-hydroxymethylbutyrate

Primary outcomes:
measure: Change from baseline handgrip strength at 12 weeks
timeFrame: From baseline till 12 weeks
measure: Change from baseline physical performance-gait speed- at 12 weeks
timeFrame: From baseline till 12 weeks
measure: Change from baseline physical performance-SPPB- at 12 weeks
timeFrame: From baseline till 12 weeks
Secondary outcomes:
measure: Number of hospital readmissions
timeFrame: From baseline till 12 weeks
measure: Change from baseline functional status at 12 weeks
timeFrame: From baseline till 12 weeks
measure: Absolute functional gain in 12 weeks
timeFrame: From baseline till 12 weeks
measure: Relative functional gain in 12 weeks
timeFrame: From baseline till 12 weeks
measure: Change from baseline rehabilitation impact indices at 12 weeks
timeFrame: From baseline till 12 weeks
measure: Number of adverse events
timeFrame: From baseline till 12 weeks
measure: Change from baseline lean and fat body mass (muscle mass) at 12 weeks
timeFrame: From baseline till 12 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de l'Esperanza
Study officials:
affiliation: Parc de Salut Mar
name: Maria Dolores Sánchez-Rodríguez, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.