Long-term safety study of the highly absorbable curcumin formulation TS-P1 in healthy Japanese adults: a randomized, placebo-controlled, double-blind, parallel-group comparative study

Abstract

Background: Curcumin, a yellow-colored molecule derived from the rhizome of Curcuma longa, has been identified as the bioactive compound responsible for numerous pharmacological activities of turmeric. However, its bioavailability is very low, limiting its potential. We have developed a novel curcumin formulation, TS-P1, which exhibits an 85.2-fold higher bioavailability than raw curcumin. Objective: The aim of this study was to evaluate the safety of long-term intake of highly bioavailable curcumin, TS-P1, in healthy Japanese adults. Methods: We conducted a randomized, placebo-controlled, double-blind, parallel-group comparison study. Ninety healthy Japanese adults were assigned to either the placebo or TS-P1 group and took 150 mg of curcumin or placebo daily for 12 weeks. Physical examinations, blood analysis, urinalysis, and medical examinations were performed every 4 weeks. Results: There were no adverse events attributed to the test foods during the study period. The mean change in body weight and body mass index (BMI) at week 12 from baseline showed a significantly greater reduction in the TS-P1 group. As there was no change in food or calorie intake between the groups during the study period, the observed weight reduction in the TS-P1 group appeared to be due to the pharmacological effect of curcumin through improved bioavailability. Conclusions: These results suggest that long-term intake of highly bioavailable curcumin, TS-P1 containing 150mg of curcumin, is safe. Keyword: Highly bioavailable curcumin; TS-P1: Theracurmin Super; Body index (BMI); Body weight (UMIN ID: UMIN000050377)