More and more consumers consider food as an important component of a healthy life and want to be convinced of the health benefits of your products or ingredients. Moreover, it is becoming increasingly important, within the current regulatory framework, to demonstrate these effects clinically. Download our whitepaper for more information.
Substantiating these health benefits is at the heart of what we do at our food clinical research department
We do so through the provision of impeccable and reliable data, coming from efficiently executed food clinical trials and by means of innovative human challenge models. Based on our long track record in pre-clinical and clinical studies on nutrition, gut health and immunity, we have developed a systematic approach to bridge the gap between preclinical in vitro assays and food clinical trials in humans. This results in a faster and more effective selection process. It will help you to stay ahead of competition and to select the right ingredients at an earlier stage.
Human challenge studies: allowing for data-driven decisions
In order to select your most promising ingredient, to determine the best way forward in the development of your product or to demonstrate health benefits, we include the use of human challenge models in our food clinical trials. Human challenge models are a unique approach to induce a physiological response in healthy subjects and to investigate how an active ingredient modulates this response. This allows you to test the efficacy of your ingredient at a relatively early stage in product development. In our human challenge studies, relatively small groups of healthy volunteers are challenged by a stressor, to allow early measurement of changes in health status. As such, human challenge studies are considerable time- and money-savers by potentially replacing your field trials or by enabling human data-driven decisions for the design of your field trials.
Human challenge studies: substantiating health benefits
Health benefits such as infection resistance, immune support or reduced glucose response help to build consumer trust. At our food clinical research department we apply human challenge models in our food clinical trials to substantiate health benefits in the areas of:
- Challenge and re-challenge with a cause of traveller’s diarrhoea and gastroenteritis (more specifically: oral attenuated diarrhoeagenic E. coli)
- Challenge with a cause of the common cold (nasal rhinovirus)
- Challenge with an oral cholera vaccine
- Challenge with a parenteral hepatitis B vaccine
- Challenge with high fat drink or mixed meal challenge, measuring postprandial kinetics of metabolic markers
Benefits of human challenge studies
- Aligned with EFSA requirements for scientific substantiation of gut and immune health benefits
- High correlation between clinical outcome parameters, subject symptom scores and e.g. markers of infection
- Fewer subjects and shorter timelines compared to population studies with random exposure
- Strictly controlled challenge models; strict (medical) supervision of subjects
- High subject compliance in following study guidelines, and low subject drop-out rates
- Experience in analysis of relevant biomarkers in collected samples
Food clinical research services
With nearly 70 years of history in food research, our food clinical research services bring you the expert resources to help you to plan, design, conduct and interpret your food clinical trials. Our approach: optimise design to maximise outcomes.
Our food clinical research services offer you the benefits of:
- Scientific and regulatory expertise: building a convincing dossier for the health benefits of your products
- Efficient clinical trial management and execution
- Unique human challenge models capabilities
- Data analysis and interpretation
- Pre-clinical in vitro models related to clinical outcomes: mechanistic insight for a cause–effect relationship can be obtained through in vivo biomarker assessment and in vitro elucidation of the mode of action
Based on our thorough understanding of the regulations, we will design your food clinical trials with only one thing in mind: substantiation of health benefits.And by means of our human challenge models, we will generate human clinical data that will allow you to determine the best way forward in the development of your product.