Effect of High Protein BCAA-Enriched Oral Nutrition Supplement (ONS) on Malnutrition in Indian Chronic Liver Disease (CLD) Patients: PROTON Study

Abstract

Background: Chronic liver disease (CLD) is a long-term progressive deterioration of liver functions, leading to fibrosis and cirrhosis. Malnutrition and sarcopenia are common in CLD patients, worsening treatment outcomes and survival rates. This study investigates the impact of an oral nutrition supplement (ONS) on malnutrition in CLD patients. Materials and Methods: A multi-centre single-arm, prospective interventional study was conducted with 76 malnourished CLD patients at Gleneagles Global Hospital and Aditya Hospitals, India (approved by institutional ethics committees and CTRI/2023/03/050644). Participants received 2 - 3 servings of scientifically designed high protein Oral Nutritional Supplement (ONS), enriched with BCAAs, and other micronutrients for three months in addition to the daily diet as per ESPEN guidelines. The study assessed changes in nutritional intake, liver enzymes, muscle mass, handgrip strength, and chronic liver disease-related quality of life (CLDQOL). The pre-post data was analyzed using paired t-test at 5% level of significance. Results: Post-supplementation, significant improvements were observed in nutritional intake, serum albumin, and liver enzymes {Aspartate Amino Transferase (AST), Alanine Transaminase (ALT)}. Handgrip strength significantly increased, indicating enhanced muscle function. A change in muscle mass was seen in both Bioelectrical Impedance (BIA) and Dual Energy X-ray Absorptiometry (DEXA) scans although the results were not statistically significant. The overall CLDQOL scores as well as individual domain scores like fatigue, emotional function and worry also showed significant improvement after intervention. The ONS effectively improved protein and BCAA intake, which is crucial for addressing malnutrition in CLD patients. Conclusion: Supplementation with high protein BCAA enriched supplement could help improve nutritional status, muscle strength, liver function parameters and quality of life in Indian patients with chronic liver disease. Further research is needed to explore the long-term effects of ONS on CLD progression and patient outcomes.