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

IF 1.3 Q4 FOOD SCIENCE & TECHNOLOGY

Functional Foods in Health and Disease Pub Date : 2023-12-20 DOI:10.31989/ffhd.v13i12.1207

Hyunjin Lee, Y. Kuwabara, Akiko Hirose, Toshihiro Kakinuma, Asami Baba, T. Takara

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引用次数: 0

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

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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

背景：姜黄素是姜黄药理作用的主要成分。它已被证明具有多种功能。它在许多领域被用作香料、着色剂、化妆品和食品防腐剂：目的：评估摄入高生物利用度姜黄素（CR-033P 和 TS-P1）对人体的安全性。方法：我们进行了两项试验：我们进行了两项试验。参与者为健康的日本成年人。试验 1（长期摄入试验）的参与者连续 12 周服用 CR-033P 或 TS-P1（姜黄素 150 毫克/天）。试验 2（过量摄入试验）的参与者连续 4 周服用 TS-P1（姜黄素 750 毫克/天）。安全性评估包括监测副作用或不良事件的发生，以及分析尿液分析和血液参数：试验 1 的安全性分析人群包括 CR-033P 组的 33 名参与者、TS-P1 组的 32 名参与者和安慰剂组的 30 名参与者。试验 2 的安全性分析人群包括 TS-P1 组的 22 名参与者和安慰剂组的 20 名参与者。在试验 1 和试验 2 中，观察到少数参与者出现不良事件，但这些不良事件与 CR-033P 或 TS-P1 无关。尿液分析和血液分析结果证实，CR-033P或TS-P1未显示出有医学问题的变化：这些试验证明，长期服用 CR-033P 或 TS-PI-（姜黄素 150 毫克/天）是安全的，过量服用 TS- P1（姜黄素 750 毫克/天）四周也是安全的。根据这些结果，TS-P1和CR-033P可被视为一种安全的姜黄素补充剂。关键词：姜黄素姜黄素、生物利用率、安全性、高剂量、长期剂量、健康日本成年人、体重指数、血压试验注册：试验 1：UMIN000046160，试验 2：UMIN000048797。基金会：Theravalues 公司

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来源期刊

Functional Foods in Health and Disease FOOD SCIENCE & TECHNOLOGY-

CiteScore

2.20

自引率

20.00%

发文量