Beta-Hydroxy-Beta-Methylbutyrate Supplementation and Physical Activity in Liver Cirrhosis: a Controlled Trial

NCT03892070 | Unknown DMC

• 1 other identifier: 5038
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is an independent predictor of morbidity and mortality in the cirrhotic patient. Beta-hydroxy-beta-methyl butyrate (HMB) is a leucine metabolite with potential efficacy in increasing protein synthesis, muscle mass, and its functionality. The aim of this randomized controlled study is to evaluate the effect of nutritional supplementation with HMB and physical activity both on muscle mass and on muscle function in cirrhotic patients.

Conditions

Sarcopenia; Cirrhosis, Liver

Keywords

HMB; Physical exercise

Outcome Measures

Primary Outcomes (1)

• Changes in Fat Free Mass Index after 12 weeks of supplementation

  Increase of Fat Free Mass evaluated by BIA

  12 weeks after the enrollment

Secondary Outcomes (5)

• Changes in Fat Free Mass Index after 24 weeks of supplementation

  24 weeks after the enrollment

• Changes in HG Test at 12 and 24 weeks after enrollment

  12 and 24 weeks after enrollment

• Changes in 6MWT Test at 12 and 24 weeks after enrollment

  12 and 24 weeks after enrollment

• Evaluation og Animal Naming and The Psychometric Hepatic Encephalopathy Score (PHES)

  12 and 24 weeks after enrollment

• Evaluation of hospitalization and decompensation episodes

  12 and 24 weeks after enrollment

Study Arms (2)

HMB GROUP

EXPERIMENTAL

HMB Supplementation with 1.5 g of HMB taken twice daily. Supplementation will be provided for 12 weeks

Dietary Supplement: BETA-HYDROXY-BETA-METHYLBUTYRATE (HMB)

PLACEBO GROUP

PLACEBO COMPARATOR

Mannitol 1.5 g twice daily. Supplementation will be provided for 12 weeks

Dietary Supplement: Mannitol

Interventions

BETA-HYDROXY-BETA-METHYLBUTYRATE (HMB) DIETARY_SUPPLEMENT

1.5 g of HMB will be provided for 12 weeks twice daily

HMB GROUP

Mannitol DIETARY_SUPPLEMENT

1.5 g twice daily for 12 weeks

PLACEBO GROUP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all cirrhotics followed in outpatients' clinic 18-70 years

You may not qualify if:

• hepatocellular carcinoma or other neoplastic diseases;
• neuromuscular or skeletal diseases,
• chronic renal failure II-III degree;
• cardiac decompensation with New York Heart Association (NYHA) score ≥ III;
• severe pulmonary dysfunction;
• active alcohol intake in the last 6 months;
• ascites grade moderate-severe

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Gastroenterology Department, Sapienza University of Rome

Rome, 00100, Italy

RECRUITING

Related Publications (5)

• Giusto M, Lattanzi B, Albanese C, Galtieri A, Farcomeni A, Giannelli V, Lucidi C, Di Martino M, Catalano C, Merli M. Sarcopenia in liver cirrhosis: the role of computed tomography scan for the assessment of muscle mass compared with dual-energy X-ray absorptiometry and anthropometry. Eur J Gastroenterol Hepatol. 2015 Mar;27(3):328-34. doi: 10.1097/MEG.0000000000000274.

  PMID: 25569567 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

• Montano-Loza AJ, Meza-Junco J, Prado CM, Lieffers JR, Baracos VE, Bain VG, Sawyer MB. Muscle wasting is associated with mortality in patients with cirrhosis. Clin Gastroenterol Hepatol. 2012 Feb;10(2):166-73, 173.e1. doi: 10.1016/j.cgh.2011.08.028. Epub 2011 Sep 3.

  PMID: 21893129 BACKGROUND

• Molfino A, Gioia G, Rossi Fanelli F, Muscaritoli M. Beta-hydroxy-beta-methylbutyrate supplementation in health and disease: a systematic review of randomized trials. Amino Acids. 2013 Dec;45(6):1273-92. doi: 10.1007/s00726-013-1592-z. Epub 2013 Sep 22.

  PMID: 24057808 BACKGROUND

• Aversa Z, Alamdari N, Castillero E, Muscaritoli M, Rossi Fanelli F, Hasselgren PO. beta-Hydroxy-beta-methylbutyrate (HMB) prevents dexamethasone-induced myotube atrophy. Biochem Biophys Res Commun. 2012 Jul 13;423(4):739-43. doi: 10.1016/j.bbrc.2012.06.029. Epub 2012 Jun 13.

  PMID: 22705301 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Liver Cirrhosis; Motor Activity

Interventions

beta-hydroxyisovaleric acid; Mannitol

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: patients do not know if they are placebo or HMB group. Investigators who perform measurement and patients visit do not know the group of patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: March 1, 2019
• Primary Completion: December 10, 2019
• Study Completion: September 10, 2020
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

IT (1)