Impact of Soy Processing Methods on Clinical Allergenicity (Short Title: Soy Processing and Food Allergy)
| Registry | NCT07485699 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, other |
| Enrollment | 55 (Estimated) |
| Sponsor | University of Zurich (Other) |
| Conditions | Soy Allergy |
| Interventions | Skin prick test (SPT) (Procedure) |
| Dates | start 2026-05-31 (estimated), primary completion 2028-08-31 (estimated), completion 2029-08-31 (estimated), first posted 2026-03-20, last updated 2026-03-20 |
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All trials for Soy Allergy All trials of Skin prick test (SPT)
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| primary soy allergy | Other | Procedure: Skin prick test (SPT) | in-vitro-tests and skin prick test (SPT) in patients with primary soy allergy |
| secondary soy allergy | Other | Procedure: Skin prick test (SPT) | in-vitro-tests and skin prick test (SPT) in patients with secondary soy allergy |
| controls | Other | Procedure: Skin prick test (SPT) | in-vitro-tests and skin prick test (SPT) in participants without soy allergy |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria: * Age 18-75 * Signed informed consent * primary soy allergy or secondary soy allergy or control (no soy allergy) Exclusion Criteria: * 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)