Evaluation of a Single Daily Dose of a Plant-Based Nutraceutical for Subclinical Changes in Liver Function in Healthy Adults: An Exploratory, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Background There is growing interest in supplements to support liver health. Previous clinical trials evaluating an organic liquid nutraceutical formulation containing a mix of turmeric, dandelion, ginger, and milk thistle demonstrated favorable modulation of liver function markers in both healthy adults and those with fatty liver disease. Objective To evaluate the efficacy and safety of once daily supplementation of the liquid nutraceutical formulation on liver function in healthy adults. Methods This randomized, double-blind, placebo-controlled, clinical study enrolled healthy adults (18 to 60 years) with normal liver function. Participants were randomized 1:1 to receive the test product or placebo once daily, provided as a 60 mL oral solution, for 90 days. The primary outcome was change in liver enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT]) from baseline to end of treatment and was compared between study arms utilizing analysis of covariance. Results 108 participants enrolled and were randomized (n=54 per group). The mean ± standard deviation change from baseline for the test product and placebo groups were –3.5 ± 4.3 IU/L and +2.5 ± 7.4 IU/L for ALT (p <0.001), –2.7 ± 4.1 IU/L and +2.5 ±7.4 IU/L for AST (p <0.001), –7.6 ± 17.1 U/L and +6.2 ± 16.7 U/L for ALP (p <0.001), and –6.1 ± 10.9 IU/mL and +4.0 ± 6.8 IU/mL for GGT (p <0.001). No adverse events were reported. Conclusion Once daily supplementation with this liquid nutraceutical formulation was safe, feasible, and significantly improved markers of liver function in healthy adults. The lower levels of ALT, AST, and GGT within the normal range noted in this study may be associated with clinical benefit. The findings at this single daily dose may support compliance among those aiming to support their liver health.