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A 12-week, randomized, double-blind study to evaluate the efficacy and safety of liver function after using fermented
Su-Jin Jung1,2, Ji-Hyun Hwang1, Soo-Hyun Park1
1Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.
Background:
Recently, clinical research has suggested that red ginseng components play a role in liver protection and combating fatigue. However, fermented ginseng has not been analyzed for liver-protective or anti-fatigue effects.
Objective:
This study evaluates the positive effects of fermented ginseng powder (GBCK25) on liver function.
Methods:
Ninety participants with elevated alanine aminotransferase levels (35 ≤ ALT ≤1 05 IU/L) were randomized to one of three groups. The participants were treated with GBCK25 tablets at a dose of 500 mg/day (high dose), 125 mg/day (low dose), or placebo group daily for 12 weeks. The primary outcomes included changes in ALT and gamma-glutamyl transferase (GGT) levels. The secondary outcomes included changes in aspartate amino-transferase (AST), high-sensitivity C-reactive protein (hs-CRP), multidimensional fatigue scale, lipid profile, and antioxidant markers.
Results:
In male subjects, after 12 weeks of low-dose GBCK25 (125 mg) supplementation, the GGT (P = 0.036) and hs-CRP (P = 0.021) levels decreased significantly more than those in the placebo group. High-dose GBCK25 (500 mg) supplementation significantly decreased the fatigue score compared with the placebo group. There were no clinically significant differences between the groups when studying any safety parameter.
Conclusion:
Our results suggest that GBCK25 supplementation has beneficial effects on liver function.
Trial Registration:
This study was registered at Clinical Trials.gov (NCT03260543).
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