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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT04858412
Status
Recruiting
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Conditions

  • Alcoholic Liver Disease
  • COVID 19 Pneumonia

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • β-hydroxy β-methyl butyrate (HMB) enriched amino acid — DIETARY_SUPPLEMENT
    β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
  • Balanced amino acid — DIETARY_SUPPLEMENT
    Balanced amino acid is the balanced mixture of the various essential amino acids.

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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

Primary Outcome Measure

Change in skeletal muscle mass at Day 0 and Day 90 [ Time Frame: Baseline and Day 90 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Annette Bellar, MSLA
[email protected]
216-445-0688
Alina Tuladhar, MPH
[email protected]
216-445-6268
Srinivasan Dasarathy, MD (PRINCIPAL_INVESTIGATOR)

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