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Search / Trial NCT04246918

Effect of BCAA Supplementation on Muscle Mass, Muscle Quality and Molecular Markers of Muscle Regeneration in CLD Patients

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Jan 28, 2020

Trial Information

Current as of May 29, 2025

Completed

Keywords

Chronic Liver Disease Sarcopenia Myostatin Health Related Quality Of Life Muscle Histology

ClinConnect Summary

Reduction in muscle mass (sarcopenia) is well documented in patients with chronic liver disease (CLD)leading to increased morbidity, mortality and poor quality of life. An equilibrium is maintained between the synthesis and degradation of muscles to maintain the muscle mass. However, an imbalance between the synthesis and degradation leads to loss of muscle mass. Various factors like alteration in dietary intake, hyper-metabolism, changes in amino acid profile, decreased physical activity, endotoxemia, hyperammonemia, increased myostatin levels have been postulated in the pathogenesis of mu...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with decompensated cirrhosis (CTP 7-9)
  • Adult patients Age 18-60 years
  • Patients with corrected BMI in the range \<22.9
  • Those who give consent for muscle biopsy
  • INR \<1.5 or 1.5-2.5 after correction with Vitamin K
  • Platelets \> 80000
  • All etiologies
  • Exclusion Criteria:
  • Presence of overt hepatic encephalopathy
  • Patients with co-morbidities e.g. acquired immunodeficiency syndrome, HCC, Other cancer, Diabetes Mellitus, chronic kidney disease, congestive heart disease , chronic respiratory disease
  • Patients with alcohol intake in past 3 months
  • Patients with TIPS
  • Patients on steroids
  • INR \>2.5
  • Refusal to participate in the trial

About Institute Of Liver And Biliary Sciences, India

The Institute of Liver and Biliary Sciences (ILBS) in India is a premier research and healthcare institution dedicated to the advancement of knowledge and treatment in liver, biliary, and related diseases. As a clinical trial sponsor, ILBS is committed to conducting innovative and ethically-driven research to improve patient outcomes and enhance therapeutic options in hepatology. The institute fosters collaboration among multidisciplinary teams of clinicians, researchers, and healthcare professionals, ensuring rigorous scientific methodologies and adherence to regulatory standards. Through its focus on translational research, ILBS aims to bridge the gap between laboratory discoveries and clinical applications, ultimately contributing to the global understanding and management of liver diseases.

Locations

New Delhi, Delhi, India

Patients applied

0 patients applied

Trial Officials

Puja Bhatia, MSc

Principal Investigator

Institute of Liver and Biliary Sciences

Jaya Benjamin, PhD

Study Director

Institute of Liver and Biliary Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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