Jung Su-Jin, Baek Hyang-Im, Park Eun-Ock, Ha Ki-Chan, Park Deuk-Seon, Chae Soo-Wan, Lee Seung-Ok
Clinical Trial Center for Functional Foods, Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju 54907, Republic of Korea.
Clinical Trial Center for K-FOOD Microbiome, Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju 54907, Republic of Korea.
Food Funct. 2025 Mar 3;16(5):1708-1719. doi: 10.1039/d4fo03361b.
The human immune system plays a crucial role in defending the body against various infections, viruses, and external substances, contributing to overall well-being. However, an imbalance in the immune system can lead to increased susceptibility to infections, impacting overall health. Preclinical investigations suggest the potential application of L. and seed complex extract (PPCE) as a potent biological response modifier in terms of immunity. However, the safety and efficacy of PPCE in boosting immune function have not been investigated clinically. The present study aims to evaluate the safety and efficacy of PPCE on the immune system in healthy adults. An 8-week randomized, double-blinded, placebo-controlled cross-over clinical trial was adopted for the study. Study participants were administered either 1080 mg day of a PPCE supplement or a placebo. The study assessed the Natural Killer (NK) cell activity as the primary outcome measure. Serum concentrations of cytokines (IL-6, IL-12, IFN-γ, TNF-α) and a questionnaire-based assessment of upper airway infection were the secondary outcomes. At the end of the 8 weeks, NK cell activity significantly improved in the PPCE group compared to the placebo group ( < 0.05). Similarly, the concentrations of IFN-γ and IL-12 significantly increased ( < 0.05). However, there were no significant differences between the two groups in the cytokines IL-6 and TNF-α. Additionally, no adverse effects were observed during the trial. These findings suggest that PPCE supplementation is safe and potentially benefits immune stimulation by enhancing NK cell activity and inducing the production of Th-1 type cell-stimulating cytokines like IL-12 in healthy individuals.
人体免疫系统在保护身体抵御各种感染、病毒和外部物质方面发挥着关键作用，有助于整体健康。然而，免疫系统失衡会导致感染易感性增加，影响整体健康。临床前研究表明，枸杞和葡萄籽复合提取物（PPCE）作为一种强大的生物反应调节剂在免疫方面具有潜在应用价值。然而，PPCE在增强免疫功能方面的安全性和有效性尚未进行临床研究。本研究旨在评估PPCE对健康成年人免疫系统的安全性和有效性。该研究采用了一项为期8周的随机、双盲、安慰剂对照交叉临床试验。研究参与者被给予每日1080毫克的PPCE补充剂或安慰剂。该研究将自然杀伤（NK）细胞活性作为主要结局指标进行评估。细胞因子（IL-6、IL-12、IFN-γ、TNF-α）的血清浓度以及基于问卷的上呼吸道感染评估为次要结局。在8周结束时，与安慰剂组相比，PPCE组的NK细胞活性显著改善（P<0.05）。同样，IFN-γ和IL-12的浓度显著升高（P<0.05）。然而，两组在细胞因子IL-6和TNF-α方面没有显著差异。此外，在试验期间未观察到不良反应。这些发现表明，补充PPCE是安全的，并且可能通过增强健康个体的NK细胞活性和诱导产生如IL-12等Th-1型细胞刺激细胞因子而对免疫刺激有益。
