PDF(Pubmed)
Abstract：
The study objective was to examine the role of a formulation, UP360, containing rosemary and Poria cocos extracts and Aloe vera gel powder, in healthy adults on supporting immune function with influenza vaccination. A 56-day randomized, triple-blind, placebo-controlled, parallel study consisted of a 28-day pre-vaccination period, an influenza vaccination on Day 28 and a 28-day post-vaccination period. Men and women ages 40-80 who had not yet been vaccinated for the flu were randomized to UP360 or Placebo (n = 25/group). At baseline, Days 28 and 56, blood lymphocyte populations, immunoglobulins (Ig), and cytokines were measured, and quality of life (QoL) questionnaires administered. The Wisconsin Upper Respiratory Symptom Survey (WURSS)-24 was completed daily by participants to measure incidence of upper respiratory tract infection (URTIs). In the post-vaccination period, TCR gamma-delta (γδ+) cells, known as γδ T cells, increased with UP360 supplementation compared to Placebo (p < 0.001). The UP360 group had a 15.6% increase in influenza B-specific IgG levels in the post-vaccination period (p = 0.0006). UP360 significantly increased the amount of circulating glutathione peroxidase (GSH-Px) from baseline at Day 28 (p = 0.0214), an enzyme that is important for neutralizing free radicals. While UP360 supplementation initially decreased levels of anti-inflammatory cytokine IL-1RA in the pre-vaccination period, IL-1RA levels were increased in the post-vaccination period (p ≤ 0.0482). Levels of IL-7 increased from baseline at Day 56 with UP360 supplementation (p = 0.0458). Despite these changes in immune markers, there were no differences in URTI symptoms or QoL between UP360 and Placebo. These results suggest UP360 supplementation was beneficial in eliciting a healthy, robust immune response in the context of vaccination. No changes in subjective measures of URTI illness or QoL demonstrated that participants\' QoL was not negatively impacted by UP360 supplementation. There were no differences in clinical chemistry, vitals or adverse events confirming the good safety profile of UP360. The trial was registered on the International Clinical Trials Registry Platform (ISRCTN15838713).
摘要：
这项研究的目的是检验一种制剂的作用，UP360，含有迷迭香和茯苓提取物和芦荟凝胶粉，在健康成年人中使用流感疫苗接种支持免疫功能。一项为期56天的随机调查，三盲，安慰剂对照,平行研究包括疫苗接种前28天，在第28天和疫苗接种后28天接种流感疫苗。尚未接种流感疫苗的40-80岁的男性和女性被随机分配到UP360或安慰剂组（n=25/组）。在基线,第28天和第56天，血液淋巴细胞群，免疫球蛋白（Ig），和细胞因子被测量，和生活质量(QoL)问卷。参与者每天完成威斯康星州上呼吸道症状调查（WURSS）-24，以测量上呼吸道感染（URTI）的发生率。在疫苗接种后，TCRγ-δ(γδ+)细胞,称为γδT细胞，与安慰剂相比，补充UP360增加（p<0.001）。在疫苗接种后,UP360组有15.6%的乙型流感特异性IgG水平增加(p=0.0006)。UP360在第28天显著增加了循环谷胱甘肽过氧化物酶（GSH-Px）的量（p=0.0214），一种对中和自由基很重要的酶。虽然UP360补充剂最初在疫苗接种前降低了抗炎细胞因子IL-1RA的水平，IL-1RA水平在疫苗接种后增加（p≤0.0482）。在第56天补充UP360时,IL-7的水平从基线增加(p=0.0458)。尽管免疫标志物发生了这些变化，UP360和安慰剂之间的URTI症状或QoL没有差异。这些结果表明，UP360补充剂有利于引发健康，在疫苗接种的背景下，强大的免疫反应。URTI疾病或QoL的主观测量没有变化，表明参与者的QoL没有受到UP360补充的负面影响。临床化学没有差异，确认UP360良好安全性的生命体征或不良事件。该试验在国际临床试验注册平台（ISRCTN15838713）上注册。
