Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training

Sarcopenia Clinical Trial

— PSSMAR  

Official title:

The PSSMAR Study (Postacute Sarcopenia, Supplementation With β-hydroxyMethylbutyrate After Resistance Training)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679742
• Other study ID #: PSSMAR 2015/6288/I
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: February 6, 2021

Study information

• Verified date: April 2020
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 6, 2021
• Est. primary completion date: February 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 ß-hydroxymethylbutyrate

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• ß-hydroxymethylbutyrate
ß-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks
• Placebo
Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks

Locations

Country	Name	City	State
Spain	Hospital de l'Esperanza	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère 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. Erratum in: Age Ageing. 2019 Jul 1;48(4):601. — View Citation

Reginster JY, Beaudart C, Al-Daghri N, Avouac B, Bauer J, Bere N, Bruyère 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. 2020 Jul 31. doi: 10.1007/s40520-020-01663-4. [Epub ahead of print] Review. — View 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. — View Citation

Sánchez-Rodríguez D, Marco E, Dávalos-Yerovi V, López-Escobar J, Messaggi-Sartor M, Barrera C, Ronquillo-Moreno N, Vázquez-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. — View Citation

Sánchez-Rodríguez D, Marco E, Miralles R, Fayos M, Mojal S, Alvarado M, Vázquez-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. — View Citation

Sánchez-Rodríguez D, Marco E, Miralles R, Guillén-Solà A, Vázquez-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. — View Citation

Sánchez-Rodríguez D, Marco E, Ronquillo-Moreno N, Miralles R, Mojal S, Vázquez-Ibar O, Escalada F, Muniesa JM. The PSSMAR study. Postacute sarcopenia: Supplementation with ß-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of hospital readmissions	Admissions in acute care due to medical health issues	From baseline till 12 weeks
Secondary	Change from baseline functional status at 12 weeks	Functional status assessed by the Barthel index	From baseline till 12 weeks
Secondary	Absolute functional gain in 12 weeks	Absolute functional gain measured with Barthel scale	From baseline till 12 weeks
Secondary	Relative functional gain in 12 weeks	Relative functional gain measured with Barthel scale	From baseline till 12 weeks
Secondary	Change from baseline rehabilitation impact indices at 12 weeks	Rehabilitation Efficiency Index	From baseline till 12 weeks
Secondary	Number of adverse events	Adverse events will be collected by medical interview during the study	From baseline till 12 weeks
Secondary	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