Hyunjin Lee, Y. Kuwabara, Akiko Hirose, Toshihiro Kakinuma, Asami Baba, T. Takara
{"title":"高生物利用度姜黄素在日本健康成年人中的安全性评估：随机、安慰剂对照、双盲、平行组比较研究","authors":"Hyunjin Lee, Y. Kuwabara, Akiko Hirose, Toshihiro Kakinuma, Asami Baba, T. Takara","doi":"10.31989/ffhd.v13i12.1207","DOIUrl":null,"url":null,"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","PeriodicalId":12623,"journal":{"name":"Functional Foods in Health and Disease","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2023-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety evaluation of high bioavailability curcumin in Healthy Japanese Adults: A Randomized, placebo-controlled, double-blind, parallel-group comparison study\",\"authors\":\"Hyunjin Lee, Y. Kuwabara, Akiko Hirose, Toshihiro Kakinuma, Asami Baba, T. Takara\",\"doi\":\"10.31989/ffhd.v13i12.1207\",\"DOIUrl\":null,\"url\":null,\"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\",\"PeriodicalId\":12623,\"journal\":{\"name\":\"Functional Foods in Health and Disease\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2023-12-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Functional Foods in Health and Disease\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.31989/ffhd.v13i12.1207\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"FOOD SCIENCE & TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Functional Foods in Health and Disease","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.31989/ffhd.v13i12.1207","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
Safety evaluation of high bioavailability curcumin in Healthy Japanese Adults: A Randomized, placebo-controlled, double-blind, parallel-group comparison study
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
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