Efficacy Confirmatory Study of Foods Containing Garcinia indica Extract on Liver Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Abstract

Obje ctives: A randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate the impact of foods containing Garcinia indica extract on liver function in healthy participants. Methods: Eighty healthy participants (alanine aminotransferase (ALT) ≤ 50 U/L, aspartate aminotransferase (AST) ≤ 50 U/L, gamma-glutamyl transferase ( γ -GTP) ≤ 100 U/L, and body mass index < 30) were enrolled and randomly divided into two groups: the active group, who consumed food containing G. indica extract (18.0 mg/day of garcinol) for 12 weeks, and the placebo group, who consumed food without G. indica extract for the same duration. The primary outcome—the serum ALT and AST levels—was evaluated along with secondary outcomes, including γ -GTP and a Likert scale questionnaire on stool form. Results: There was a statistically significant difference in the ALT and AST levels ( P < 0.05) between the active group and the placebo group. No adverse events attributable to the test foods were observed during the study period. Furthermore, the initial values of ALT and AST levels of the active group subjects in this study were slightly higher than the national average values reported in the 2019 National Health and Nutrition Survey published by the Ministry of Health, Labour and Welfare in Japan. Conclusions: Overall, these findings indicate that foods containing G. indica extract contributed to a slight reduction in ALT and AST levels, which, although within the normal range, were marginally elevated in healthy participants.