Safety evaluation of high bioavailability curcumin in Healthy Japanese Adults: A Randomized, placebo-controlled, double-blind, parallel-group comparison study

Abstract

Background:  Curcumin is the principal component responsible for the pharmacological action of Curcuma longa. It has been proven to exhibit a diverse range of functions. It has been used in many fields as a spice, coloring agent, cosmetic, and food preservative.Objective: To evaluate the safety of the intake of highly bioavailable curcumin (CR-033P and TS-P1) in humans. Methods: We conducted two trials. The participants were healthy Japanese adults.  Participants of tria1 1 (Long-term intake trial) took CR-033P or TS-P1 for 12 weeks (as curcumin 150 mg/day). Participants of Trial 2 (Excessive intake trial) took TS-P1 for 4 weeks (as curcumin 750 mg/day).  The safety assessment involved monitoring the occurrence of side effects or adverse events, along with the analysis of urinalysis and blood parameters.Results: The safety analysis population of Trial 1 included 33 participants in the CR-033P group, 32 participants TS-P1, and 30 participants in the Placebo group. The safety analysis population of trial 2 included 22 participants in TS-P1 and 20 participants in the Placebo group. In both Trial 1 and Trial 2, few participants were observed to experience adverse events and  however these were not adverse events related to the CR-033P or TS-P1. Results of urinalysis and blood analysis were confirmed to not exhibit medically problematic changes related to the CR-033P or TS-P1.Conclusions: These trials proved the safety of the long-term intake of CR-033P or TS-PI- (as curcumin 150mg/ day) and the safety of the excessive intake of TS- P1 for four weeks (as curcumin 750mg/ day). TS-P1 and CR-033P can be considered a safe curcumin supplement based on these results.     Keywords: Curcumin, bioavailability, safety, high dose, long term dose, Healthy Japanese Adults, BMI, Blood pressure Trial registration: Trial 1: UMIN000046160, Trial 2: UMIN000048797. Foundation:Theravalues Corporation