A proprietary blend of quail egg for the attenuation of nasal provocation with a standardized allergenic challenge: a randomized, double-blind, placebo-controlled study.
A proprietary blend of quail egg for the attenuation of nasal provocation with a standardized allergenic challenge: a randomized, double-blind, placebo-controlled study.
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DOI：
10.1002/fsn3.147
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发表时间：
2014-11
影响因子：
3.9
通讯作者：
Tetard, Jan
中科院分区：
文献类型：
--
作者：
Benichou, Annie-Claude;Armanet, Marion;Bussiere, Anthony;Chevreau, Nathalie;Cardot, Jean-Michel;Tetard, Jan
接触污染或过敏原引起的偶尔鼻炎症状是一个日益令人担忧的问题。首先，根据经验观察，在饲养鹌鹑的农民中较少发生过敏，然后根据对卵粘蛋白特性的科学研究，我们开发了一种膳食补充剂，以缓解这种偶尔出现的鼻炎症状。这项研究的目的是确定与安慰剂相比，与安慰剂相比，一次急性口服研究产品是否可以减轻暴露于标准化过敏原挑战后的鼻部刺激和其他过敏相关症状。健康受试者被招募参加一项随机、双盲、双臂交叉、安慰剂对照的临床试验。一次急性剂量的活性研究产品(专有的鹅蛋混合物)或安慰剂与标准化的过敏原挑战同时给予。主要终点是最大鼻吸气流量(PNIF)测量，次要终点是基于过敏相关症状的视觉模拟评分(VAS)以及免疫球蛋白E计数的受试者感知的幸福感。43名健康受试者入选，并可按方案进行评估。PNIF从最低点到第120次的逐渐增加反映了主动组和安慰剂组由过敏原刺激引起的鼻塞的正常、逐渐恢复。在挑战后的所有时间点，与安慰剂组相比，主动组的PNIF值更高，这表明活性产品与较少的症状和这些症状的强度相关。根据VAS评分，这种活性产品还在统计上显著改善了大多数受试者的幸福感。在研究过程中没有发生不良反应。综上所述，这种由鹌鹑蛋制成的专有混合物组成的膳食补充剂可以快速有效地缓解由最常见的室外和室内过敏原引起的过敏性鼻炎症状，且没有不良反应。
Occasional rhinitis symptoms caused by exposure to pollution or allergens is a growing concern. Based first on empirical observation of a lesser occurrence of allergies in quail farmers and then scientific works on ovomucoids properties, we developed a dietary supplement for the relief of such occasional rhinitis symptoms. The objective of the study was to determine whether one acute oral dose of the study product attenuates nasal provocation and other allergy-related symptoms after exposure to a standardized allergenic challenge as compared to placebo. Healthy subjects were recruited to participate in a randomized, double-blind, two-arm crossover, placebo-controlled, clinical trial. One acute dose of either the active study product (proprietary blend of quail egg) or placebo was given concomitantly to the standardized allergenic challenge. The primary endpoint was peak nasal inspiratory flow (PNIF) measurement and the secondary endpoints were subjects' perceived feelings of well-being based on Visual Analog Scale (VAS) scores for allergy-related symptoms, as well as immunoglobulin E count. Forty-three healthy subjects were enrolled and evaluable in a per protocol analysis. A gradual increase in PNIF from nadir up to Time 120 reflected the normal, gradual recovery from nasal obstruction induced by allergenic challenge for both the active and the placebo groups. At all postchallenge time points, the active group had higher PNIF values compared to the placebo group, indicating that the active product was associated with fewer symptoms and reduced intensity of these symptoms. The active product resulted also in statistically significant improvements of most of the subjects' perceived feelings of well-being based on VAS scores. No adverse events occurred during the study. In conclusion, the dietary supplement consisting of proprietary blend made of quail eggs provides fast and efficient relief of allergic rhinitis symptoms caused by the most common outdoor and indoor allergens, without adverse events.