Our research tools
At NIZO we approach the substantiation of health benefits from three angles:
- In vitro models
for understanding the mechanism of action of your product
- Microbiome and biomarker analysis
for understanding the mechanism of action of your product and support of clinical outcomes
- Challenge tests with (controlled) human challenge models for data driven decisions based on clinical trial endpoints
Health defined as ‘the ability to adapt to stressors’ forms the basis of our challenge tests. We expose healthy human subjects to a moderate stressor and determine the effect of (the active ingredients of ) our clients’ product on their physiological response. Stressors used could be for example a high-fat meal, to test metabolic flexibility, or a vaccination, to test the immune response, or a gut or respiratory infection, to test the immune defence against pathogens. All our human challenge studies include a control group and are conducted double blind.
(Controlled) human challenge models
At NIZO we have unique expertise to incorporate controlled human challenge models in our food clinical trials. ‘Controlled’ means that we have full control over the stressor, its dose and its timing. Our clients often prefer these controlled challenge models over traditional human field studies during which natural exposure to pathogens is expected to occur. The traditional studies require a longer study duration and more participants than studies that use a controlled human challenge model.