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

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ClinicalTrials.gov Identifier: NCT03892070
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 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 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.


Condition or disease Intervention/treatment Phase
Sarcopenia Cirrhosis, Liver Dietary Supplement: BETA-HYDROXY-BETA-METHYLBUTYRATE (HMB) Dietary Supplement: Mannitol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Beta-Hydroxy-Beta-Methylbutyrate Supplementation and Physical Activity in Liver Cirrhosis: a Controlled Trial
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : September 10, 2020


Arm Intervention/treatment
Experimental: HMB GROUP
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)
1.5 g of HMB will be provided for 12 weeks twice daily

Placebo Comparator: PLACEBO GROUP
Mannitol 1.5 g twice daily. Supplementation will be provided for 12 weeks
Dietary Supplement: Mannitol
1.5 g twice daily for 12 weeks




Primary Outcome Measures :
  1. Changes in Fat Free Mass Index after 12 weeks of supplementation [ Time Frame: 12 weeks after the enrollment ]
    Increase of Fat Free Mass evaluated by BIA


Secondary Outcome Measures :
  1. Changes in Fat Free Mass Index after 24 weeks of supplementation [ Time Frame: 24 weeks after the enrollment ]
    Increase of Fat Free Mass evaluated by BIA

  2. Changes in HG Test at 12 and 24 weeks after enrollment [ Time Frame: 12 and 24 weeks after enrollment ]
    Recovery of muscle mass function evaluated by Recovery of muscle mass function evaluated by Hand grip Test (HG)

  3. Changes in 6MWT Test at 12 and 24 weeks after enrollment [ Time Frame: 12 and 24 weeks after enrollment ]
    Recovery of muscle mass function evaluated by 6 minute walk test-6MWT

  4. Evaluation og Animal Naming and The Psychometric Hepatic Encephalopathy Score (PHES) [ Time Frame: 12 and 24 weeks after enrollment ]
    evaluation of minimal hepatic encephalopathy

  5. Evaluation of hospitalization and decompensation episodes [ Time Frame: 12 and 24 weeks after enrollment ]
    episodes of decompensation during th study



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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT03892070


Locations
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Italy
Gastroenterology Department, Sapienza University of Rome Recruiting
Rome, Italy, 00100
Contact: Manuela Merli    +39 06 49972002    manuela.merli@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza

Publications:

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Responsible Party: Manuela Merli, Associate Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03892070     History of Changes
Other Study ID Numbers: 5038
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 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:
HMB
Physical exercise

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Sarcopenia
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs