Challenge models: the path to health claims
NIZO challenge models assess the effect of foods and ingredients in healthy people by introducing controlled stressor.
Nutrition can help maintaining one’s health. Health can be assessed by looking at the body's ability to adapt to changing circumstances and to show sufficient resilience. This concept of ability to adapt to stressors, forms the basis of so-called challenge models.
At NIZO, challenge models are routinely applied to studies in both animals as well as humans. These studies include a control group and a group that receives the investigational product, who are afterwards both exposed to the stressor. To assess the effects on immune response, infection resistance, metabolic health and gut barrier, randomized controlled trials in healthy adults are performed with among others:
- 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).
- a challenge with a high fat, high glucose meal
- a challenge with NSAIDs
The use of these challenge models in clinical trials generates early human data to enable:
- selection of the most promising ingredient
- determination of the best way forward in the development of the product
- optimization of design of field trials
- demonstration of health benefits
NIZO has a great track record in pre-clinical as well as clinical studies verifying health benefits and underlying mechanisms. Regulatory and scientific guidance is provided to build a dossier with consistent pre-clinical and clinical data that support the beneficial health effect.
NIZO has developed an integrated pipeline of pre-clinical models and early stage Proof of Concept clinical trials. All with one goal in mind: to help food and ingredient companies to select the right ingredients with the largest chance of success as quickly as possible.