Validate the impact of your food ingredient on infection resistance and immune response with fewer participants and in a shorter timeframe using challenge studies

Consumers around the world are looking for foods that boost their infection resistance and immune response. This has led to steady growth in new products that offer immune health benefits, but these claims need to be supported by evidence.

Clinical trials offer a scientifically validated approach for substantiating the infection resistance or immune response claim of your ingredient. However, relying on ‘natural’ exposure to pathogens can significantly extend the timeframe of your study and increase the number of participants needed. It also increases the risk that volunteers will not conform to the study specifications or will drop out altogether.

By inducing symptoms or disturbing the physiological balance through the introduction of a controlled ‘stressor’, you can speed up validation, while requiring fewer participants. So you can get your food immune health claim substantiated more quickly and cost-efficiently.

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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 
Any questions?

Ioana Iorga is happy to answer all your questions.

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