CClinicalTrials.gg
RecruitingNCT04858412Updated Sep 25, 2026

Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19

An interventional study of β-hydroxy β-methyl butyrate (HMB) enriched amino acid and Balanced amino acid in Alcoholic Liver Disease and COVID 19 Pneumonia, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

Patients with COVID-19 and comorbidities including alcohol associated liver disease (ALD) are at risk for severe illness and abrupt or sudden clinical deterioration with ventilatory failure. â-hydroxy â-methyl butyrate (HMB), a non-nitrogenous leucine metabolite with anabolic properties, increases muscle mass and contractile function and enhances immune function. We aim to study the natural course of COVID-19 in patients with ALD and test whether HMB can affect ventilatory deterioration and improve short and long-term morbidity, mortality, and recovery from critical illness in symptomatic COVID-19 patients with ALD.

02

Conditions studied

  • Alcoholic Liver Disease
  • COVID 19 Pneumonia
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

A. Cases: Patients with ALD and COVID-19 pneumonia:

  1. Clinical, imaging, laboratory, and/or histological diagnosis of alcoholic cirrhosis and/or alcoholic hepatitis
  2. Child Pugh score 5-8, serum creatinine \<3, Model for End Stage Liver Disease score (MELD) \<25
  3. Diagnosis of COVID-19 pneumonia as defined by the WHO criteria: confirmed SARS-CoV-2 infection by PCR, evidence of bilateral pulmonary infiltrates on chest radiograph (CXR) or computed tomography (CT) and SpO2 \<93% or on oxygen supplement
  4. Age of 21 years or older

B. Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia:

  1. Diagnosis of COVID-19 pneumonia as defined by the WHO criteria: confirmed SARS-CoV-2 infection by PCR, evidence of bilateral pulmonary infiltrates on chest radiograph (CXR) or computed tomography (CT) and SpO2 \<93% or on oxygen supplement
  2. Age of 21 years or older

Exclusion Criteria: (Both Cases and Controls)

  1. Patients requiring active ventilator support
  2. Anticoagulant/antiplatelet therapy (for those in the biopsy arm, see Randomization schema. If clinically feasible, patients will be asked to hold their anticoagulants for the muscle biopsy after physician review),
  3. Recent gastrointestinal bleeding (\<3 months)
  4. Advanced organ diseases: congestive heart failure (NYHA class 3 and 4), chronic obstructive pulmonary diseases (COPD) (GOLD stage 3 and 4), chronic kidney disease (Cr>3), metastatic malignancy
  5. Medications that alter muscle protein metabolism except systemic corticosteroids
  6. Pregnancy
  7. Unwillingness/ Inability to sign informed consent
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    HMB enriched amino acid arm

    The patients randomized to the HMB enriched amino acid (HMB/EAA) arm will be given HMB/EAA for 90 days.

    Dietary Supplement: β-hydroxy β-methyl butyrate (HMB) enriched amino acid

  • Placebo comparator
    Balanced amino acid arm

    The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days.

    Dietary Supplement: Balanced amino acid

Interventions

  • Dietary supplementβ-hydroxy β-methyl butyrate (HMB) enriched amino acid

    β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.

  • Dietary supplementBalanced amino acid

    Balanced amino acid is the balanced mixture of the various essential amino acids.

05

What researchers measure

Primary outcomes

  1. Change in skeletal muscle mass at Day 0 and Day 90

    Time frame: Baseline and Day 90

  2. Number of hospital admissions between Day 0 and Day 90

    Time frame: Baseline and Day 90

06

Study locations

1 of 1 sites recruiting
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
    • Annette Bellar, MSLA · Contact · bellara@ccf.org · 216-445-0688
    • Alina Tuladhar, MPH · Contact · tuladha@ccf.org · 216-445-6268
    • Srinivasan Dasarathy, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04858412
Lead sponsor
The Cleveland Clinic
Responsible party
Srinivasan Dasarathy (Staff, The Cleveland Clinic) — Principal investigator
First posted
Apr 26, 2021
Start date
Apr 1, 2021
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Annette Bellar, MSLA
Contact
bellara@ccf.org
216-445-0688
Alina Tuladhar, MPH
Contact
tuladha@ccf.org
216-445-6268
Srinivasan Dasarathy, MD
principal investigator · Staff

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion