Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training

NCT02679742 | Completed

• 1 other identifier: PSSMAR 2015/6288/I
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

beta hydroxy beta methylbutyrate; older people; muscle mass; muscle strength; post-acute

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Number of hospital readmissions

  From baseline till 12 weeks

• Change from baseline functional status at 12 weeks

  From baseline till 12 weeks

• Absolute functional gain in 12 weeks

  From baseline till 12 weeks

• Relative functional gain in 12 weeks

  From baseline till 12 weeks

• Change from baseline rehabilitation impact indices at 12 weeks

  From baseline till 12 weeks

Study Arms (2)

β-hydroxymethylbutyrate

EXPERIMENTAL

β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program

Dietary Supplement: β-hydroxymethylbutyrate

Placebo

PLACEBO COMPARATOR

Maltodextrin 3 grams once a day combined with a resistance training program

Dietary Supplement: Placebo

Interventions

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

β-hydroxymethylbutyrate

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

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital de l'Esperanza

Barcelona, 09024, Spain

Location

Related Publications (8)

• 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.

  PMID: 27823730 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.

  PMID: 32737844 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.

  PMID: 26051706 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.

  PMID: 24726179 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.

  PMID: 31789867 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.

  PMID: 30312372 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.

  PMID: 31233072 BACKGROUND

• 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.

  PMID: 38171034 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Maria Dolores Sánchez-Rodríguez, PhD, MD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 10, 2016
• Study Start: March 1, 2017
• Primary Completion: February 6, 2021
• Study Completion: February 6, 2021
• Last Updated: February 10, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)