Soy Processing and Food Allergy

NCT07485699 | Not Yet Recruiting

• 1 other identifier: Soy Processing Food Allergy
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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

Conditions

Soy Allergy

Outcome Measures

Primary Outcomes (1)

• Frequency of sensitization (in vitro/in vivo) to processed soy proteins

  Frequency of sensitization (in vitro/in vivo) to processed soy proteins compared to unprocessed soy proteins in patients with known soy allergy

  one-time (in-vitro diagnostic/skin prick test)

Secondary Outcomes (3)

• 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)

Study Arms (3)

primary soy allergy

OTHER

in-vitro-tests and skin prick test (SPT) in patients with primary soy allergy

Procedure: Skin prick test (SPT)

secondary soy allergy

OTHER

in-vitro-tests and skin prick test (SPT) in patients with secondary soy allergy

Procedure: Skin prick test (SPT)

controls

OTHER

in-vitro-tests and skin prick test (SPT) in participants without soy allergy

Procedure: Skin prick test (SPT)

Interventions

Skin prick test (SPT) PROCEDURE

skin prick test according SOPs

controls; primary soy allergy; secondary soy allergy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Signed informed consent
• primary soy allergy or secondary soy allergy or control (no soy allergy)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

MeSH Terms

Interventions

Patch Tests

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Marie-Charlotte Brüggen, MD PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Studienteam Allergologie

CONTACT

+41 43 253 1075; studienteam.allergologie@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03