Safety Evaluation of Theracurmin® in Healthy Japanese Adults―A Randomized, Double—blind, Placebo—controlled Parallel—group Study―

Objectives　We aimed to evaluate the safety in humans of 4-week excessive and 12-week long-term intake of Theracurmin®（highly bioavailable curcumin）through a randomized, placebo-controlled, double-blind, parallel-group study. Methods　We conducted two trials from May to July 2018（trialⅠ, excessive intake trial）or May to October 2018（trialⅡ, long-term intake trial）. For both trials, participants who provided informed consent and met the inclusion criteria were allocated equally but randomly into either the Theracurmin® group（T group, n＝16）or the placebo group（P group, n＝16）, using a computerized random-number generator. In trialⅠ, participants took 10 capsules of either Theracurmin®（approximately 90 mg of curcumin╱capsule）or placebo twice per day with water after breakfast and dinner （five capsules each meal）for 4 weeks. In trialⅡ, participants took two capsules per day of either Theracurmin® or placebo with water after breakfast and dinner （one capsule after each meal）for 12 weeks. The safety evaluation included physical examination, urinalysis, blood analysis, and subjective symptoms. Results　One participant did not have a satisfactory ingestion rate（＜90％）and thus was excluded from the analysis; the remaining 31 participants were analyzed as per protocol（T group n＝15; P group n＝16）in both trialsⅠ and Ⅱ. No adverse effects were reported regarding the test food. Conclusions　These trials proved the safety of 4-week excessive and 12-week long-term intake of Theracurmin®. Trial registration　UMIN-CTR: UMIN000032640（trialⅠ, excessive intake）; UMIN000032641 （trialⅡ, long-term intake） Funding　THERAVALUES CORPORATION