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天然补充剂IQP-AS-119预防马拉松参赛者上呼吸道感染的研究:一项随机、双盲、安慰剂对照的试点研究。

Investigation of the natural supplement IQP-AS-119 for the prevention of upper respiratory tract infections in marathon race participants: A randomized, double-blind, placebo-controlled pilot study.

作者信息

Bongartz Udo, Hochmann Uwe, Pohl Ute, Bothe Gordana, Costa Patricia De, Chong Pee-Win, Chew Lynette, Uebelhack Ralf

机构信息

Analyze Analyze & Realize GmbH, D-13467 Berlin, Germany.

InQpharm Group Sdn Bhd, Kuala Lumpur 50480, Malaysia.

出版信息

Exp Ther Med. 2021 Feb;21(2):144. doi: 10.3892/etm.2020.9575. Epub 2020 Dec 16.

Abstract

Intense and prolonged exercise leads to immune suppression, causing upper respiratory tract infections (URTI). A proprietary standardized dietary supplement, IQP-AS-119 has been previously developed to aid immune responses under such conditions. The current randomized, double-blind, placebo-controlled pilot study aimed to investigate the effects of IQP-AS-119 on marathon runners. A total of 80 participants were randomized equally into groups receiving either placebo (P group) or IQP-AS-119 (V group) treatment, starting 3 weeks before and for 14 days after the marathon. Benefit assessment was performed using different questionnaires. Post-marathon, the V and P groups reported 1±2.38 and 2.11±3.25 days with upper respiratory tract symptoms (URTS), respectively (P=0.038). During the 14 days post-marathon, 20.0% of the participants in the V group compared with 44.4% in the P group reported URTS (P=0.042). The V group reported significantly milder URTS compared with the P group on Days 9, 12, 13 and 14 post-marathon (P<0.05). The total Perceived Stress Questionnaire-20 score on days 2-14 were significantly lower for the V group compared with the P group (P=0.035). In the Short Form 12 Health Survey, the V group exhibited significant improvement in mental composite score on days -5 to 14 compared with the P group (P=0.038). In the overall treatment effect assessment, there were no statistically significant differences between the groups. The IQP-AS-119 was rated 'very good' or 'good' by investigators and participants, respectively, for 71 and 65% of the participants. The tolerability of IQP-AS-119 was rated as 'very good' or 'good' by both investigators and 95% of participants. No clinically relevant differences were observed between groups regarding adverse events or other safety parameters. Therefore, IQP-AS-119 was demonstrated to reduce the incidence and severity of URTI in marathon runners. Given its good tolerability profile, IQP-AS-119 may be a good nutritional supplement for the reduction of URTS in susceptible individuals.

摘要

剧烈且持续的运动会导致免疫抑制,引发上呼吸道感染(URTI)。此前已研发出一种专利标准化膳食补充剂IQP-AS-119,用于在这种情况下辅助免疫反应。当前这项随机、双盲、安慰剂对照的试点研究旨在调查IQP-AS-119对马拉松运动员的影响。总共80名参与者被平均随机分为接受安慰剂(P组)或IQP-AS-119(V组)治疗的组,在马拉松比赛前3周开始并在比赛后持续14天。使用不同问卷进行效益评估。马拉松赛后,V组和P组报告出现上呼吸道症状(URTS)的天数分别为1±2.38天和2.11±3.25天(P = 0.038)。在马拉松赛后的14天内,V组20.0%的参与者报告出现URTS,而P组为44.4%(P = 0.042)。在马拉松赛后第9、12、13和14天,V组报告的URTS明显比P组轻(P < 0.05)。与P组相比,V组在第2 - 14天的总感知压力问卷 - 20得分显著更低(P = 0.035)。在简短健康调查问卷12中,与P组相比,V组在第 - 5至14天的心理综合得分有显著改善(P = 0.038)。在总体治疗效果评估中,各组之间无统计学显著差异。分别有71%和65%的参与者认为IQP-AS-119对研究者和参与者来说“非常好”或“好”。研究者和95%的参与者都将IQP-AS-119的耐受性评为“非常好”或“好”。在不良事件或其他安全参数方面,各组之间未观察到临床相关差异。因此,已证明IQP-AS-119可降低马拉松运动员上呼吸道感染的发生率和严重程度。鉴于其良好的耐受性,IQP-AS-119可能是一种用于减少易感个体URTS的良好营养补充剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6c50/7791916/5b12fbf25d39/etm-21-02-09575-g00.jpg

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