Based on our thorough understanding of the regulations, we design these food clinical trials with only one thing in mind: substantiation of the health benefit of the product we are testing. For our customers this means gaining profound knowledge of the mechanism of action (MoA), the substantiation of health benefits, or both.
At NIZO we have over 70 years of experience in food research. We have extensive experience with all aspects of successful food clinical trials and health benefit substantiation.
Our clinical research services
Our food clinical research services offer you expert resources for all aspects of your food clinical trials, such as:
- Scientific consultancy: building a convincing dossier for the health benefit of your product
- Appropriate study design and advice on clinical outcomes
- Fast IRB approvals
- Efficient trial management and planning
- Management of external clinical sites
- Reliable subject recruitment
- Smooth trial execution
- Correct sample and data handling
- Statistical data analysis
- Scientific data interpretation and report writing
Challenge tests at NIZO
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.
Application areas human challenge studies
We apply human challenge models in the areas of
- Metabolic health (high fat drink or mixed meal challenge)
- Immune response (commercially available cholera and hepatitis B vaccin)
- Infection resistance (oral infection with our diarrhoea causing E. coli strain; nasal infection with a common cold virus, in collaboration with Academic Medical Centre, Amsterdam)
- Gut barrier function (NSAID challenge)
Benefits of human challenge studies
Our controlled human challenge studies have the following benefits:
- Strategic benefits: alignment with EFSA requirements for scientific substantiation of gut and immune response health benefits.
- Financial benefits: fewer subjects needed and shorter timelines compared to population studies with random exposure to stressors.
- Scientific benefits: reproducible outcomes; high correlation between clinical outcome parameters, subject symptom scores and biomarkers of infection;
- Organizational benefits: high subject compliance in following study guidelines, and low subject drop-out rates
Product categories for food clinical trials
NIZO conducts food clinical trials for many different products. For example:
- Dairy ingredients
- Plant proteins
- Bioactive peptides
- Dietary fibers