METHODS: Eighty participants aged 19-64 yrs old with a white blood cell count of 4,000-10,000 cells/µL, symptoms of upper respiratory infection at least once within the previous 12 mon, and perceived stress scale (PSS) over 14 were included. Participants were randomly assigned to take either 1,000 mg/day OPE or a placebo for 8 weeks.
RESULTS: Compliance were 87.4 ± 8.6% and 86.9 ± 79.0% in OPE and placebo groups. Compared to the placebo, OPE supplementation improved \"Hoarseness\" (P = 0.038) of the Wisconsin Upper Respiratory Symptom Survey (WURSS)-21 symptom, and stress scores (P = 0.001; 0.021) of PSS. Supplementation of OPE had no significant effect on NK cell activity and concentrations of cytokines such as interleukin (IL)-2, IL-6, IL-12, IL-1β, interferon-γ, and tumor necrosis factor-α. At baseline, the WURSS-21 symptom and PSS score (P = 0.024; 0.026) were higher in the OPE group than the placebo group. Among participants with higher than median WURSS-21 symptom score, OPE supplementation increased NK cell activity (P = 0.038). Supplementation of OPE had no significant effects on safety measurements and adverse events.
CONCLUSIONS: The present study suggested that OPE supplementation improves NK cell activity in participants with moderate upper respiratory symptoms without any significant adverse effects.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT05666752.
方法:80名年龄在19-64岁的参与者,白细胞计数为4,000-10,000个细胞/μL,在过去的12个月内至少有一次上呼吸道感染的症状,包括14岁以上的感知压力量表(PSS)。参与者被随机分配服用1000毫克/天的OPE或安慰剂8周。
结果:OPE组和安慰剂组的依从性分别为87.4±8.6%和86.9±79.0%。与安慰剂相比,补充OPE改善了威斯康星州上呼吸道症状调查(WURSS)-21症状的“声音嘶哑”(P=0.038),和压力评分(P=0.001;0.021)的PSS。补充OPE对NK细胞活性和白细胞介素(IL)-2、IL-6、IL-12、IL-1β等细胞因子浓度无显著影响,干扰素-γ,和肿瘤坏死因子-α.在基线,OPE组的WURSS-21症状和PSS评分(P=0.024;0.026)高于安慰剂组.在WURSS-21症状评分高于中位数的参与者中,OPE补充增加NK细胞活性(P=0.038)。补充OPE对安全性测量和不良事件没有显著影响。
结论:本研究表明,补充OPE可以改善中度上呼吸道症状参与者的NK细胞活性,而没有任何明显的不良反应。
■ClinicalTrials.gov标识符:NCT05666752。