Challenge models: the path to health claims
NIZO challenge models assess the effect of foods and ingredients in healthy people by introducing controlled stressor.
In order to determine whether food or food ingredient s are healthy, it is important to be able to assess human health. One way of assessing health is to look at the body's ability to adapt to changing circumstances and to show sufficient resilience under conditions of social, physical and emotional disturbance (challenge).
NIZO has developed challenge models, both in animals as well as in humans. These models determine how the human body can cope with such ´challenges’ in the context of infection resistance. In these models NIZO applies moderate stresses, such as a vaccination or a gut or respiratory infection. The challenge studies include a control group and a group that receives potentially resistance boosting ingredients who are afterwards both exposed to an attenuated (i.e. debilitated) gut or respiratory pathogen. At NIZO randomized controlled trials in healthy adults are performed with:
- A challenge with an oral cholera vaccine.
- A challenge with an oral attenuated diarrheagenic E. coli strain (cause of travelers’ diarrhea/gastroenteritis).
- A challenge with a nasal rhinovirus (cause of common cold).
NIZO has a great track record in preclinical as well as clinical studies verifying health benefits and underlying mechanisms. Developing new functional ingredients with health claims like ‘supports resistance against infections’ is an error-prone, often long - and hence expensive - process. The dossier for health claim substantiation needs to contain consistent pre-clinical and clinical data that support the beneficial health effect of a specific food or food ingredient.
NIZO’s aim is to help food and ingredient companies to select the right ingredients with the largest chance of success. To achieve this, NIZO is developing a new integrated pipeline of preclinical models and early stage Proof of Concept (PoC) clinical trials in the PEARL project (‘Pipeline for Efficiency evaluation of Active ingredients for Resistance and alLergy’), in collaboration with various food and ingredient companies.