{"title":"高吸收性姜黄素制剂 TS-P1 在日本健康成年人中的长期安全性研究:随机、安慰剂对照、双盲、平行组比较研究","authors":"Hyunjin Lee, Y. Kuwabara, Akiko Hirose, Yuji Makino, Kyohei Hashimoto, Misaki Sakata, Tadashi Watanabe","doi":"10.31989/ffhd.v14i7.1396","DOIUrl":null,"url":null,"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.\nObjective: The aim of this study was to evaluate the safety of long-term intake of highly bioavailable curcumin, TS-P1, in healthy Japanese adults.\nMethods: 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.\nResults: 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.\nConclusions: These results suggest that long-term intake of highly bioavailable curcumin, TS-P1 containing 150mg of curcumin, is safe.\nKeyword: Highly bioavailable curcumin; TS-P1: Theracurmin Super; Body index (BMI); Body weight\n(UMIN ID: UMIN000050377)","PeriodicalId":1,"journal":{"name":"Accounts of Chemical Research","volume":"50 10","pages":""},"PeriodicalIF":16.4000,"publicationDate":"2024-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Hyunjin Lee, Y. Kuwabara, Akiko Hirose, Yuji Makino, Kyohei Hashimoto, Misaki Sakata, Tadashi Watanabe\",\"doi\":\"10.31989/ffhd.v14i7.1396\",\"DOIUrl\":null,\"url\":null,\"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.\\nObjective: The aim of this study was to evaluate the safety of long-term intake of highly bioavailable curcumin, TS-P1, in healthy Japanese adults.\\nMethods: 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.\\nResults: 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.\\nConclusions: These results suggest that long-term intake of highly bioavailable curcumin, TS-P1 containing 150mg of curcumin, is safe.\\nKeyword: Highly bioavailable curcumin; TS-P1: Theracurmin Super; Body index (BMI); Body weight\\n(UMIN ID: UMIN000050377)\",\"PeriodicalId\":1,\"journal\":{\"name\":\"Accounts of Chemical Research\",\"volume\":\"50 10\",\"pages\":\"\"},\"PeriodicalIF\":16.4000,\"publicationDate\":\"2024-07-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Accounts of Chemical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.31989/ffhd.v14i7.1396\",\"RegionNum\":1,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accounts of Chemical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.31989/ffhd.v14i7.1396","RegionNum":1,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
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
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)
期刊介绍:
Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance.
Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.