Substantiating your immune health claims
Depending on the type of health benefit you want to validate, NIZO can design and coordinate the execution of an infection resistance or immunity benefit study on your ingredient, in line with the requirements of the European Food Safety Authority (EFSA). For example:
- Designing the human intervention study
- Obtaining ethical approval
- Adding a strictly controlled ‘stressor’ such as
- a vaccination to test the immune response
- a gut pathogen to test the immune defence
- Assessing the effect on symptoms and gut health biomarkers
- Analysing the data and writing a concise clinical report that conforms with EFSA guidelines
- Providing tailored consultancy and guidance based on your study results
Scientific consultancy to build a convincing dossier
At NIZO, we have unique expertise in infection resistance and immune response challenge models that incorporate a ‘stressor’. For infection resistance, we have developed our own human model for E. coli studies. For immune response challenge studies, we use commercially available cholera and hepatitis B vaccines.
We maintain full control over the stressor, its dose and its timing. These studies include a control group and are conducted double blind.
Our infection resistance and immune response studies:
- Align with EFSA requirements for scientific substantiation of gut and immune response health benefits.
- Require fewer subjects and shorter timelines compared to population studies with random exposure to stressors.
- Offer relevant outcomes, with high correlation between clinical outcome parameters, subject symptom scores and biomarkers of infection
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