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NCT Number: NCT07485699

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Skin prick test (SPT)

Procedure

skin prick test according SOPs

Primary outcomes

  1. 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

Secondary outcomes

  1. Sensitization patterns in primary and secondary soy allergy

    Time frame: one time (skin prick test, in vitro diagnostic)

    Compare sensitization patterns between primary and secondary soy allergy to processed soy proteins

  2. Degree of sensitization of soy allergic patients;

    Time frame: one time (skin prick test)

    Degree of sensitization of soy allergic patients;

  3. Correlation with clinical characteristics

    Time frame: one time (skin prick test)

    Correlation of sensitizations with clinical characteristics (such as severity of reaction, type of soy allergy)

Study contacts

Contact information is provided by the study sponsor or research team.

Studienteam Allergologie

CONTACT

[email protected]

+41 43 253 1075

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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