A randomised double blind placebo-controlled clinical trial to evaluate the effects of Liv-Pro- a food supplement for Non-Alcoholic Fatty Liver Disease.

BACKGROUND: Non-alcoholic Fatty Liver Disease (NAFLD) involves excessive fat build-up in the liver unrelated to alcohol use. This study aimed to evaluate the clinical efficacy and safety of Liv-Pro capsules, a formulation combining Osbeckia octandra and Aloe vera, in managing NAFLD. This is the first report of the clinical trial using this combination against NAFLD. METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted with 30 NAFLD patients from February 1, 2021 to March 31, 2023. Participants received either Liv-Pro or a placebo (two capsules once a day) for two months. Medical assessments at baseline, one month, and two months included liver function tests (ALT and AST), abdominal ultrasound scan, serum creatinine analysis, and lipid profile assessment. All patients were advised on lifestyle modifications. RESULTS: Liv-Pro significantly reduced ALT levels after one month (p = 0.049) and two months (p = 0.048) compared to baseline. AST levels also decreased significantly in the first (p = 0.047) and second months (p = 0.046), showing a consistent decline. Liv-Pro reduced total cholesterol, triglycerides, and Low-density lipoprotein (LDL) levels significantly after one and two months (p < 0.05) compared to baseline measurements. Abdominal ultrasound scans showed a significant decrease in hepatic fat content after two months (p = 0.020). Serum creatinine levels remained stable throughout the treatment period. CONCLUSION: Liv-Pro was well-tolerated with no reported side effects, suggesting its potential as a safe and effective therapeutic option for NAFLD. Continuous administration of Liv-Pro is recommended for sustained efficacy.