Effects of Highly Bioavailable Curcumin Supplementation on Common Cold Symptoms and Immune and Inflammatory Functions in Healthy Japanese Subjects: A Randomized Controlled Study

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 (<i>n</i> = 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.

本研究旨在探究12周持续摄入高生物利用度姜黄素（curcumin，每日150mg的Theracurmin Super[TS-P1]或Theracurmin[CR-033P]）对普通感冒症状、免疫功能及炎症标志物的影响。本研究于2021年11月至2022年5月期间，针对99名健康日本成年人开展了一项随机双盲安慰剂对照试验。通过计算机随机数生成器，将每名受试者随机分配至TS-P1组、CR-033P组或安慰剂组，每组各33例。受试者每日服用分配的4粒受试制剂，干预周期为12周。本研究的主要结局指标为普通感冒症状持续的累计天数。免疫参数、炎症参数、肝功能参数及体格检查结果作为次要结局指标。此外，本研究同步开展了安全性评估。最终共有94名受试者完成本研究；符合方案集（per protocol set）中，安慰剂组纳入30例、TS-P1组32例、CR-033P组33例。数据分析显示，TS-P1组与CR-033P组受试者的普通感冒症状持续累计天数均显著低于安慰剂组。本研究未观察到不良事件发生。每日摄入150mg的高生物利用度姜黄素制剂TS-P1或CR-033P、持续12周，可降低健康日本成年人的普通感冒症状持续天数。