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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03234920
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Manuela Merli, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: BETA-HYDROXY-BETA-METHYLBUTYRATE (HMB) Other: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Beta-hydroxy-beta-methylbutyrate (HMB) Supplementation After Liver Transplantation: Randomized and Controlled Pilot Study
Actual Study Start Date : September 25, 2015
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group 1- Control Group
Placebo The placebo will be 200 ml of fruit juice twice a day. Placebo will be provided for 12 weeks
Other: Placebo
The placebo will be 200 ml of fruit juice given twice daily

Experimental: Group 2 - Treatment group
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)
1.5 g of HMB dissolved in 200 ml of fruit juice will be provided for 12 weeks twice daily




Primary Outcome Measures :
  1. Changes in Fat Free Mass Index 3-4 months after transplantation [ Time Frame: 3-4° months after transplantation ]
    Increase of Fat Free Mass Index-FFMI (FFMI) evaluated by DEXA


Secondary Outcome Measures :
  1. Changes in Fat Free Mass Index 6 and 12 months after transplantation [ Time Frame: 6° and 12° months after transplantation ]
    Increase of Fat Free Mass Index-FFMI (FFMI) evaluated by DEXA

  2. Changes in 6MWT at 3-4, 6 and 12 months after transplantation [ Time Frame: 3°-4°, 6° and 12° months after transplantation ]
    Recovery of muscle mass function evaluated by minute walk test-6MWT

  3. Changes in test-TUGT at 3-4, 6 and 12 months after transplantation [ Time Frame: 3°-4°, 6° and 12° months after transplantation ]
    Recovery of muscle mass function evaluated by Timed Up and Go test-TUGT

  4. Changes in HG Test at 3-4, 6 and 12 months after transplantation [ Time Frame: 3°-4°, 6° and 12° months after transplantation ]
    Recovery of muscle mass function evaluated by Recovery of muscle mass function evaluated by Hand grip Test (HG)

  5. Evaluation of days of hospitalization during the study period [ Time Frame: 3°-4°, 6° and 12° months after transplantation ]
    Days of Hospitalization will be recorded

  6. Evaluation of onset of metabolic syndrome after liver transplantation classified sec. APT III classification [ Time Frame: 3°-4°, 6° and 12° months after transplantation ]
    onset of metabolic syndrome diagnosed by ATP III classification

  7. Incidence of Treatment-Emergent Adverse Events evaluated to analog-visual scale [ Time Frame: 3°-4°, 6° and 12° months after transplantation ]
    Tolerability of supplementation evaluated to analog-visual scale



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Liver transplantation

Exclusion Criteria:

  • 1. Multiple organ transplantation
  • 2. Low compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234920


Locations
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Italy
Gastroenterology Department, Sapienza University of Rome
Rome, Italy, 00100
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Manuela Merli, Prof Sapienza University of Rome

Additional Information:
Publications:
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

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Responsible Party: Manuela Merli, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03234920     History of Changes
Other Study ID Numbers: URomLSHMB
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manuela Merli, University of Roma La Sapienza:
cirrhosis
liver transplantation
HMB

Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms