Soy AllergyNCT07485699
Soy Processing and Food Allergy
A study testing Skin prick test (SPT) in people with Soy Allergy, run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Soy Allergy
- What is being tested?
- Skin prick test (SPT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75
- Signed informed consent
- primary soy allergy or secondary soy allergy or control (no soy allergy)
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Soy Allergy
- Being tested
- Skin prick test (SPT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin prick test (SPT)Procedure or surgery
skin prick test according SOPs
| Study group | Role | What they receive |
|---|---|---|
| primary soy allergy | Other | in-vitro-tests and skin prick test (SPT) in patients with primary soy allergy Receives: Procedure: Skin prick test (SPT) |
| secondary soy allergy | Other | in-vitro-tests and skin prick test (SPT) in patients with secondary soy allergy Receives: Procedure: Skin prick test (SPT) |
| controls | Other | in-vitro-tests and skin prick test (SPT) in participants without soy allergy Receives: Procedure: Skin prick test (SPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one-time (in-vitro diagnostic/skin prick test)
Secondary outcomes (3)
Sensitization patterns in primary and secondary soy allergy
Compare sensitization patterns between primary and secondary soy allergy to processed soy proteins
Measured: one time (skin prick test, in vitro diagnostic)
Degree of sensitization of soy allergic patients;
Degree of sensitization of soy allergic patients;
Measured: one time (skin prick test)
Correlation with clinical characteristics
Correlation of sensitizations with clinical characteristics (such as severity of reaction, type of soy allergy)
Measured: one time (skin prick test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start31 May 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soy AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- in vitro test and skin prick test in three patient groups (primary soy allergy, secondary soy allergy, controls)
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Charlotte Brüggen, MD PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485699
- Sponsor's protocol ID
- Soy Processing Food Allergy
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Soy Processing Methods on Clinical Allergenicity (Short Title: Soy Processing and Food Allergy)
- ClinicalTrials.gov ID
- NCT07485699
- Acronym / sponsor ID
- Soy Processing Food Allergy
- Conditions
- Soy Allergy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- in vitro test and skin prick test in three patient groups (primary soy allergy, secondary soy allergy, controls)
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75
- Signed informed consent
- primary soy allergy or secondary soy allergy or control (no soy allergy)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin prick test (SPT)skin prick test according SOPs | Procedure or surgery | controls, primary soy allergy, secondary soy allergy |
Primary outcome
Frequency of sensitization (in vitro/in vivo) to processed soy proteins
Time frame: 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
3 secondary outcomes
Sensitization patterns in primary and secondary soy allergy
Time frame: one time (skin prick test, in vitro diagnostic)
Degree of sensitization of soy allergic patients;
Time frame: one time (skin prick test)
Correlation with clinical characteristics
Time frame: one time (skin prick test)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
Related trials for Soy Allergy
Active, not recruitingPhase 1
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
Food Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Charlotte Brüggen, MD PhD principal investigator
University of Zurich
Questions about this trial
What is this clinical trial studying?
A study testing Skin prick test (SPT) in people with Soy Allergy, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Studienteam Allergologie (+41 43 253 1075, studienteam.allergologie@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of sensitization (in vitro/in vivo) to processed soy proteins (time frame: one-time (in-vitro diagnostic/skin prick test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.