Effects of Theracurmin® consumption on liver function, fatigue, and sleep: a randomized, double-blind, placebo- controlled, parallel-comparison study | Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Skip to main content Skip to main navigation menu Skip to site footer Open Menu Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Home Food Science Publisher Functional Food Center Current Archives About About the Journal Aims and Scope Contact Editing Services Editorial Team Express Peer Review Graphical Abstract Journal Insights Privacy Statement Submissions Announcements Search Search Register Login Home / Archives / Vol. 11 No. 6 (2021): June 2021 / Research Articles Effects of Theracurmin® consumption on liver function, fatigue, and sleep: a randomized, double-blind, placebo- controlled, parallel-comparison study Authors Yoshitaka Kuwabara Akiko Hirose Hyunjin Lee Daisuke Hashimoto Shin-ichiro Iio Tsuyoshi Takara DOI: https://doi.org/10.31989/ffhd.v11i6.794 Abstract Objective: To evaluate the effects of the eight-week consumption of Theracurmin® on liver function, fatigue, and sleep. Methods: This was a randomized, double-blind, placebo-controlled, parallel-comparison study involving 68 healthy Japanese adults. Subjects were allocated into either the active (Theracurmin®) or placebo group (n = 34 each) using a random number generator. Subjects consumed two capsules per day of either the active or placebo food for eight weeks. The primary outcome was the serum alanine aminotransferase (ALT) levels at eight weeks, whereas the secondary outcomes were the biomarkers of liver function, comparison of the percentages of improvement in liver function based on the decision criteria, OSA sleep inventory MA version (OSA-MA), and visual analog scale of fatigue. Results: Each group included 33 subjects in the full analysis set. ALT levels in the per protocol set analysis, except for subjects drinking quantities of alcohol that increase the risk of lifestyle-related disease onset, showed a significant decrease in ALT compared to the placebo group (P < 0.05). The subjective symptom in the fatigue recovery factor of OSA-MA was significantly improved through the intervention (P < 0.05). The fatigue recovery effect of Theracurmin® was prominent in the subjects aged ≥ 45 years, the age group defined by the Ministry of Health, Labour and Welfare as middle-aged and older persons in the Act on Stabilization of Employment of Elderly. No adverse event was observed. Conclusions: These results suggest that the consumption of Theracurmin® or eight weeks improved liver function and fatigue recovery at awakening in healthy Japanese adults. Trial registration: UMIN-CTR: UMIN000039319. Foundation: Theravalues Corporation Keywords: highly bioavailable curcumin, liver function, alanine aminotransferase (ALT), OSA sleep inventory MA version, fatigue recovery Downloads [Abstract] [Full Article] [Appendix] Published 2021-06-17 Issue Vol. 11 No. 6 (2021): June 2021 Section Research Articles License Authors retain the copyright of their articles and grant the Functional Food Center (FFC) and its journals the right of first publication under the terms of the Creative Commons Attribution 4.0 International License. This license permits unrestricted use, distribution, and reproduction in any medium, including commercial use, provided the original author(s) and source are properly credited. Authors may post and share their published work freely, provided that the original publication in this journal is acknowledged. By submitting to this journal, authors confirm that their manuscripts are original, not under consideration elsewhere, and that they hold the necessary rights to grant this license. The Functional Food Center encourages open scientific exchange and allows derivative and extended works, provided attribution to the original publication is maintained. About the Journal      Editing Services      Graphical Abstract      Journal Insights        Submissions        Editorial Team       Privacy Statement        Contact        Current        Archives   Open Journal Systems Hosting and Support by: OpenJournalSystems.com