Soy Processing and Food Allergy

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Soy Allergy
• Intervention / Treatment: Procedure: Skin prick test (SPT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Studienteam Allergologie; Phone Number: +41 43 253 1075; Email: studienteam.allergologie@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: primary soy allergy; in-vitro-tests and skin prick test (SPT) in patients with primary soy allergy	Procedure: Skin prick test (SPT); skin prick test according SOPs
Other: secondary soy allergy; in-vitro-tests and skin prick test (SPT) in patients with secondary soy allergy	Procedure: Skin prick test (SPT); skin prick test according SOPs
Other: controls; in-vitro-tests and skin prick test (SPT) in participants without soy allergy	Procedure: Skin prick test (SPT); skin prick test according SOPs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Marie-Charlotte Brüggen, MD PhD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Immunologic Tests; Skin Tests; Patch Tests
• Other Study ID Numbers: Soy Processing Food Allergy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No