Effects of Theracurmin® consumption on liver function, fatigue, and sleep: a randomized, double-blind, placebo- controlled, parallel-comparison study
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
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