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Soy Processing and Food Allergy

Impact of Soy Processing Methods on Clinical Allergenicity (Short Title: Soy Processing and Food Allergy)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07485699
Enrollment
55
Registered
2026-03-20
Start date
2026-05-31
Completion date
2029-08-31
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soy Allergy

Brief summary

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

Detailed description

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.

Interventions

PROCEDURESkin prick test (SPT)

skin prick test according SOPs

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

in vitro test and skin prick test in three patient groups (primary soy allergy, secondary soy allergy, controls)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Frequency of sensitization (in vitro/in vivo) to processed soy proteinsone-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

Secondary

MeasureTime frameDescription
Sensitization patterns in primary and secondary soy allergyone time (skin prick test, in vitro diagnostic)Compare sensitization patterns between primary and secondary soy allergy to processed soy proteins
Degree of sensitization of soy allergic patients;one time (skin prick test)Degree of sensitization of soy allergic patients;
Correlation with clinical characteristicsone time (skin prick test)Correlation of sensitizations with clinical characteristics (such as severity of reaction, type of soy allergy)

Contacts

CONTACTStudienteam Allergologie
studienteam.allergologie@usz.ch+41 43 253 1075
PRINCIPAL_INVESTIGATORMarie-Charlotte Brüggen, MD PhD

University of Zurich

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026