Using HMB and amino acids to improve muscle loss in cirrhosis
HMB Enriched Amino Acids to Reverse Muscle Loss in Cirrhosis
NA · The Cleveland Clinic · NCT05166499
This study is testing if a combination of HMB and amino acids can help people with cirrhosis build muscle and improve their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05166499 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with cirrhosis of the liver and a Child-Pugh score of 5-8.
Not a fit: Patients with recent gastrointestinal bleeding, active infections, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment to reverse muscle loss in patients with cirrhosis, potentially improving their quality of life and outcomes.
How similar studies have performed: While the specific approach of using HMB and amino acids in cirrhosis is novel, preliminary studies suggest potential efficacy in addressing muscle loss.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Annette Bellar
- Email: bellara@ccf.org
- Phone: 2164456268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cirrhosis, Liver