Soy Processing and Food Allergy

Official title

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

Overview

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

• Procedure Skin prick test (SPT)
  skin prick test according SOPs

Primary outcome measures

• Frequency of sensitization (in vitro/in vivo) to processed soy proteins [Time frame: one-time (in-vitro diagnostic/skin prick test)]

Secondary outcome measures (3)

• 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07485699 · Soy Processing Food Allergy

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗