Using HMB and amino acids to improve muscle loss in cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of hydroxy methyl butyrate (HMB) and balanced amino acids to address sarcopenia, a common complication in patients with cirrhosis. The study is based on the hypothesis that impaired mTOR signaling contributes to muscle loss in cirrhosis, and that leucine can stimulate mTOR to enhance protein synthesis and reduce autophagy. By administering these interventions, the researchers aim to increase skeletal muscle mass in affected patients. The trial will quantify the effects of these treatments on muscle mass and overall health outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Annette Bellar
• Email: bellara@ccf.org
• Phone: 2164456268

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bile acid and gut microbiota changes in people with hepatitis D starting bulevirtide

  This project will see if starting bulevirtide changes bile acids and gut bacteria in adults with chronic hepatitis D who are already on hepatitis B therapy.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07429864

• Diagnosing lymphohistiocytic hemophagocytosis in intensive care patients with liver disease

  This study will test whether the HScore can accurately detect lymphohistiocytic hemophagocytosis in adults with hepatocellular insufficiency or cirrhosis admitted to intensive care.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07343037

• Echocardiography-guided intensive care for septic shock in people with cirrhosis

  This study will try using bedside ultrasound (POCUS) to guide fluid and blood-pressure treatment in adults with cirrhosis who develop sepsis-related low blood pressure.

  Recruiting Post Graduate Institute of Medical Education and Research, Chandigarh · Chandigarh · NCT07286643

• Understanding social and health needs of people with chronic liver disease in outpatient care

  This project will see how common social needs are and whether adults with chronic liver disease want their outpatient providers to help with them.

  Recruiting Indiana University · Indianapolis, Indiana · NCT07191886

• Non-invasive blood and imaging tests for metabolic liver disease

  This project tests whether blood tests and imaging scans can diagnose and stage metabolic-associated steatohepatitis (MASH) and liver fibrosis in adults with metabolic risk factors.

  Recruiting at 4 sites Foundation for the National Institutes of Health · Miami, Florida and 3 other locations · NCT07122700

• High-protein, plant-dominant diet for people with liver cirrhosis

  This 6-month test compares a high-protein, mostly plant-based diet to a usual low-fat animal-protein diet in adults with decompensated cirrhosis who are awaiting kidney transplant to see which better preserves nutrition and muscle.

  Recruiting at 2 sites Agricultural University of Athens · Athens, Attica and 1 other locations · NCT07028580

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.