Improvement in autonomic balance through 12-week supplementation of a novel curcumin formulation in healthy Japanese adults: A randomized, placebo-controlled study

Background: Curcumin has several health benefits due to its potent antioxidant and anti-inflammatory properties, but its bioavailability is very low, limiting its potential. We have developed a novel curcumin formulation, TS-P1, which has an 85.2-fold higher bioavailability of curcumin than raw curcumin. Objective: To investigate the efficacy of TS-P1 on fatigue, mood status, and autonomic function. Methods: Ninety healthy Japanese adults were randomized to the placebo or TS-P1 group and took either the placebo or TS-P1 containing 150 mg of curcumin for 12 weeks. Visual Analogue Scale for Fatigue (VAS-F) scores, Profile of Mood States Questionnaire second edition (POMS2) scores, and autonomic functions were measured every 4 weeks. Results: Both groups showed an improvement in the VAS-F over the study period, but there was no significant difference between the placebo and TS-P1 groups. However, the mean change from baseline in the anger and depression scores of the POMS2, particularly in those aged 40 and over, in the TS-P1 group showed a greater range of decline at week 12. The mean change from baseline in LnLF and LF/HF also decreased in the TS-P1 group. Blood pressure also decreased in the TS-P1 group. Conclusions: These data suggest that TS-P1 induced a parasympathetic dominant state, and that curcumin has an important role in the regulation of autonomic balance. 12 weeks of supplementation of TS-P1 is expected to improve both mood status and vascular function. Trial registration: UMIN000050377 Foundation: Theravalues Corporation Keywords: curcumin; TS-P1: Theracurmin Super; mood status; autonomic balance, parasympathetic dominance; vascular function