Long-term safety and efficacy of a highly purified plant-based nutraceutical for improving clinical parameters of liver function in healthy participants: a randomized, double-blind, placebo-controlled clinical trial.

2026-01-23
Frontiers in nutrition 12
- Ghanashyam Patel
- Saumin Shah
- Christopher R D'Adamo

PubMed: 41659807
DOI: 10.3389/fnut.2025.1721748

Study Design

Type: Clinical Trial
Sample size: n = 130
Population: 130 healthy adults
Methods: Randomized, placebo-controlled clinical trial, 60 mL twice daily for 180 days
Duration: 180 days
Funding: Unclear

Background

Liver function is foundational to human health. While numerous herbal extracts have individually been shown to improve liver function, there are relatively few studies on combinations of herbal ingredients that may have synergistic effects. In addition, capsule fatigue is a common problem when aiming to incorporate multiple ingredients to support liver health. With these gaps in mind, the goal of this study was to evaluate the safety and efficacy of a highly purified plant-based nutraceutical containing organic herbal extracts of turmeric, dandelion, milk thistle, and ginger on liver function parameters.

Methods

A randomized, placebo-controlled clinical trial was conducted to evaluate the efficacy of this nutraceutical liquid formula. Healthy adults were randomized 1:1 to receive the nutraceutical product or placebo (both 60 mL) twice daily for 180 days. The primary endpoint was change in liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alanine phosphatase [ALP], gamma-glutamyl transferase [GGT]) from baseline to end of study. Safety was also evaluated. The primary endpoint was compared between study arms via analysis of covariance.

Results

In total, 130 participants enrolled in the trial; 65 were randomized to each group. Mean improvements in ALT, AST, ALP, and GGT were significantly greater with the nutraceutical product than placebo (p ≤ 0.001). No adverse events were reported.

Discussion

Supplementation with this liquid nutraceutical formula improved the liver enzyme profile of healthy individuals, suggesting that it may mitigate a trend toward higher liver enzyme levels over time in a convenient manner that fosters compliance.

Clinical trial registration

https://ctri.nic.in/Clinicaltrials/login.php, CTRI/2023/06/054492.

Research Insights

Thistle→Reduced Alanine Aminotransferase Level
Mean improvements in ALT, AST, ALP, and GGT were significantly greater with the nutraceutical product than placebo (p ≤ 0.001).
Effect
Beneficial
Effect size
Moderate
Thistle→Reduced Alkaline Phosphatase Level
Mean improvements in ALT, AST, ALP, and GGT were significantly greater with the nutraceutical product than placebo (p ≤ 0.001).
Effect
Beneficial
Effect size
Moderate
Thistle→Reduced Aspartate Aminotransferase Levels
Mean improvements in ALT, AST, ALP, and GGT were significantly greater with the nutraceutical product than placebo (p ≤ 0.001).
Effect
Beneficial
Effect size
Moderate
Thistle→Reduced Gamma-Glutamyl Transferase Levels
Mean improvements in ALT, AST, ALP, and GGT were significantly greater with the nutraceutical product than placebo (p ≤ 0.001).
Effect
Beneficial
Effect size
Moderate