Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation

NCT03234920 | Completed DMC

• 1 other identifier: URomLSHMB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is an independent predictor of morbidity and mortality in cirrhotic patient before and after liver transplantation. 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 a nutritional supplementation with HMB after liver transplantation both on muscle mass and on muscle function.

Conditions

Sarcopenia

Keywords

cirrhosis; liver transplantation; HMB

Outcome Measures

Primary Outcomes (1)

• Changes in Fat Free Mass Index 3-4 months after transplantation

  Increase of Fat Free Mass Index-FFMI (FFMI) evaluated by DEXA

  3-4° months after transplantation

Secondary Outcomes (7)

• Changes in Fat Free Mass Index 6 and 12 months after transplantation

  6° and 12° months after transplantation

• Changes in 6MWT at 3-4, 6 and 12 months after transplantation

  3°-4°, 6° and 12° months after transplantation

• Changes in test-TUGT at 3-4, 6 and 12 months after transplantation

  3°-4°, 6° and 12° months after transplantation

• Changes in HG Test at 3-4, 6 and 12 months after transplantation

  3°-4°, 6° and 12° months after transplantation

• Evaluation of days of hospitalization during the study period

  3°-4°, 6° and 12° months after transplantation

Study Arms (2)

Group 1- Control Group

PLACEBO COMPARATOR

Placebo The placebo will be 200 ml of fruit juice twice a day. Placebo will be provided for 12 weeks

Other: Placebo

Group 2 - Treatment group

EXPERIMENTAL

HMB Supplementation with 1.5 g of HMB dissolved in 200 ml of fruit juice and taken twice daily. Supplementation will be provided for 12 weeks

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

Interventions

BETA-HYDROXY-BETA-METHYLBUTYRATE (HMB) DIETARY_SUPPLEMENT

1.5 g of HMB dissolved in 200 ml of fruit juice will be provided for 12 weeks twice daily

Group 2 - Treatment group

Placebo OTHER

The placebo will be 200 ml of fruit juice given twice daily

Group 1- Control Group

Eligibility Criteria

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

You may qualify if:

• \. Liver transplantation

You may not qualify if:

• \. Multiple organ transplantation
• \. Low compliance

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Gastroenterology Department, Sapienza University of Rome

Rome, 00100, Italy

Location

Related Publications (7)

• Dasarathy S. Consilience in sarcopenia of cirrhosis. J Cachexia Sarcopenia Muscle. 2012 Dec;3(4):225-37. doi: 10.1007/s13539-012-0069-3. Epub 2012 May 31.

  PMID: 22648736 BACKGROUND

• Merli M, Giusto M, Riggio O, et al. Improvement of nutritional status in malnourished cirrhotic patients one year after liver transplantation. eESPEN 2011 (2011) e1-e6

  BACKGROUND

• 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

• Tsien C, Garber A, Narayanan A, Shah SN, Barnes D, Eghtesad B, Fung J, McCullough AJ, Dasarathy S. Post-liver transplantation sarcopenia in cirrhosis: a prospective evaluation. J Gastroenterol Hepatol. 2014 Jun;29(6):1250-7. doi: 10.1111/jgh.12524.

  PMID: 24443785 BACKGROUND

• Aversa Z, Bonetto A, Costelli P, Minero VG, Penna F, Baccino FM, Lucia S, Rossi Fanelli F, Muscaritoli M. beta-hydroxy-beta-methylbutyrate (HMB) attenuates muscle and body weight loss in experimental cancer cachexia. Int J Oncol. 2011 Mar;38(3):713-20. doi: 10.3892/ijo.2010.885. Epub 2010 Dec 23.

  PMID: 21184031 BACKGROUND

• Gerlinger-Romero F, Guimaraes-Ferreira L, Giannocco G, Nunes MT. Chronic supplementation of beta-hydroxy-beta methylbutyrate (HMbeta) increases the activity of the GH/IGF-I axis and induces hyperinsulinemia in rats. Growth Horm IGF Res. 2011 Apr;21(2):57-62. doi: 10.1016/j.ghir.2010.12.006. Epub 2011 Jan 14.

  PMID: 21237681 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; Fibrosis

Interventions

beta-hydroxyisovaleric acid

Condition Hierarchy (Ancestors)

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

Study Officials

• Manuela Merli, Prof

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: August 1, 2017
• Study Start: September 25, 2015
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

IT (1)