Impact of Soy Processing Methods on Clinical Allergenicity (Short Title: Soy Processing and Food Allergy)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 主要终点
- Frequency of sensitization (in vitro/in vivo) to processed soy proteins
研究概览
简要总结
Soy allergies are widespread and are becoming increasingly significant today as people around the world consume more and more soy and soy-containing foods. Soy is used in many products and undergoes various processing steps such as heating, extraction, enzymatic degradation, and preservation. However, it is not yet fully understood how these processing steps affect soy's ability to trigger allergic reactions.
The goal of this project is to process soy in various controlled ways and investigate how these methods affect its allergenic potential. First, the effects will be tested in the laboratory (in vitro). Subsequently, the results will be examined in humans using a skin prick test (SPT) to determine how the processed soy affects allergic reactions
详细描述
Soy allergies are widespread and of particular concern, as the consumption of soy and soy products is increasing worldwide. Soy is processed in various ways for many foods, such as through heating, extraction, hydrolysis, and preservation. To date, little is known about the extent to which these processing steps influence the allergenicity of soy.
In this open-label, non-randomized, comparative, prospective, single-center clinical study, we aim to investigate the effects of the aforementioned processing steps on allergenicity. The project consists of various modules. The experimental parts will examine how soy can be modified through the processing steps mentioned above and how these steps can be integrated into the production of soy products. In the clinical part, the allergenicity of the modified soy products will first be tested in vitro and subsequently in skin tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75
- •Signed informed consent
- •primary soy allergy or secondary soy allergy or control (no soy allergy)
排除标准
- •Use of antihistamines within 3 days, systemic corticosteroids within 2 weeks, topical corticosteroids (test area) 1 week prior
- •Use of immunosuppressive or biologic agents
- •Active malignancy / ongoing treatment for a malignancy
- •Active or recurrent bacterial, fungal, or viral infection
- •Pregnancy
- •Drug or alcohol abuse, or any condition likely to impair compliance (e.g., language barrier, cognitive disorder, psychological illness)
结局指标
主要结局
Frequency of sensitization (in vitro/in vivo) to processed soy proteins
时间窗: one-time (in-vitro diagnostic/skin prick test)
Frequency of sensitization (in vitro/in vivo) to processed soy proteins compared to unprocessed soy proteins in patients with known soy allergy
次要结局
- Sensitization patterns in primary and secondary soy allergy(one time (skin prick test, in vitro diagnostic))
- Degree of sensitization of soy allergic patients;(one time (skin prick test))
- Correlation with clinical characteristics(one time (skin prick test))