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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This study aimed to investigate the effects of 12-week consumption of highly bioavailable curcumin (150 mg/day of Theracurmin Super [TS -P1] or Theracurmin [CR-033P]) on common cold symptoms, immune function, and inflammatory markers. A randomized, double-blind, placebo-controlled study was conducted from November 2021 to May 2022 on 99 healthy Japanese adults. Using a computerized random number generator, each subject was randomly assigned to one of the following three groups: TS -P1, CR-033P, or placebo (n = 33 per group). For 12 weeks, each group consumed the four capsules that were given to them daily. The cumulative number of days for which common cold symptoms persisted was set as the primary outcome. Immunity parameters, inflammatory parameters, liver function parameters, and physical examination results were additional outcomes. A safety assessment was also performed. Ninety-four subjects completed the study, and the per protocol set included 30 subjects in the placebo group, 32 subjects in the TS -P1 group, and 33 subjects in the CR-033P group. The cumulative number of days for which common cold symptoms persisted was significantly lower in the TS -P1 and CR-033P groups than that in the placebo group. No adverse effects were observed. Consumption of highly bioavailable curcumin, TS -P1 or CR-033P (150 mg/day), for 12 weeks reduced the number of days for which common cold symptoms persisted in healthy Japanese adults. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]