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NCT05166499From ClinicalTrials.govRecruiting

HMB Enriched Amino Acids to Reverse Muscle Loss in Cirrhosis

  • Cirrhosis, Liver

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
The Cleveland Clinic
Enrolment target
24
Started
30 November 2021
Main results due
30 December 2028
Study sites
1
Registry updated
28 September 2026

Can you take part?

  • Ages 21 years to 65 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Diagnosis of cirrhosis of the liver
* Child-Pugh score of 5-8

Exclusion Criteria:

* Recent gastrointestinal bleeding (\<3m)
* Active infection
* Overt encephalopathy
* Renal failure on dialysis
* Pedal edema
* Uncontrolled diabetes (HbA1C \> 7.9mg/dL)
* Advanced cardiac, lung, kidney disease
* Metastatic cancer
* Medications that alter muscle protein metabolism
* Pregnancy
* Recent bowel resection or gastric bypass surgery,
* INR \>1.7, platelets \<60,000/ml, serum creatinine \>2mg/dL
* Medications that interfere with blood clotting

What this study is about

In the sponsor’s own words, from the registry.

Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible complication in cirrhosis that increases morbidity and mortality before, during and after liver transplantation. No proven treatments exist for the prevention or reversal of sarcopenia in cirrhosis, primarily because the mechanisms responsible for this are unknown. Based on compelling preliminary studies and those of the co investigator, investigators hypothesize that the mechanism of reduced skeletal muscle mass in cirrhosis is due to a myostatin mediated impaired mTOR (mechanistic target of rapamycin) signaling resulting in reduced protein synthesis and increased autophagy. Investigators further postulate that leucine, a direct stimulant of mTOR, will reverse the impaired mTOR phosphorylation in the skeletal muscle of cirrhotics. The consequent increase in protein synthesis reduced autophagy will result in an increase in skeletal muscle mass. Investigators will test these hypotheses by quantifying the response to acute and long term (3 month) administration of hydroxymethyl butyrate (HMB) enriched essential amino acid compared with an isonitrogenous isocaloric non-essential balanced amino acid mixture (does not stimulate protein synthesis) in cirrhotic patients. Fractional protein synthesis rate (FSR) in skeletal muscle, responses of the molecular regulatory pathways of skeletal muscle protein synthesis, and autophagy flux will be quantified in the acute and long term protocols. Tracer studies using L-\[D5\]-phenylalanine (Phe) as a primed constant infusion (prime 2µmol.kg-1.hr-1; constant 0.05 µmol.kg-1.hr-1) with and L \[ring-D2\] tyrosine, forearm plethysmography, and sequential skeletal muscle biopsies (total of 3 per study subject) will be used to quantify these outcomes. Anthropometric, clinical and body composition measures will be additional outcome measures for the long term intervention. Expression of regulatory signaling proteins, myostatin, IGF-1 (insulin like growth factor) , phospho-Akt, phospho-AMPK (activated protein kinase), phospho-mTOR and phospho-p70s6k will be quantified by Western immunoblots. Autophagy flux will be measured by quantifying expression of the autophagosome proteins.

Study sites(1)

  • Cleveland Clinic

    Cleveland, Ohio, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05166499. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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HMB Enriched Amino Acids to Reverse Muscle Loss in Cirrhosis | Trialion