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Provide convincing evidence that your product helps intestinal comfort, in accordance with EFSA guidelines 

Around 40% of the Western population experiences digestive discomfort, such as constipation, bloating or abdominal pain. That has made intestinal health a big – and growing – business. In 2018, for example, there was a 21% increase in the launch of food and beverages making a digestive or gut health claim, in the Asia-Pacific region1.  

But to make those claims, you need evidence. Through a carefully designed and performed clinical study, you can demonstrate that your fibre, prebiotic or probiotic improves intestinal comfort. Or, alternatively, that your healthy fibre does not cause gut discomfort.  

Evaluating discomfort and measuring improvement 

NIZO can design and coordinate the execution of your study on the impact your ingredient has on gut comfort and constipation, in line with European Food Safety Authority (EFSA) requirements.  For example: 

  • Designing a clinical trial with appropriate outcome measures 
  • Obtaining ethical approval  
  • Coordination of recruitment and execution of the trial under good clinical practice conditions 
  • Analysing the data 
  • Writing a concise clinical report that can play a key role in your health claim substantiation 
  • Providing tailored consultancy and guidance based on your study results 

A comprehensive, customised approach, based on in-house expertise 

With our in-house capabilities and expertise, we can create a customised study that answers your specific questions about your functional ingredient. Using validated questionnaires, we evaluate the improvement in gut comfort and constipation amongst volunteers who represent a target population suffering from intestinal discomfort.  

But we can go further: enriching your clinical trial with an analysis of microbiota changes, gut health or inflammatory markers, local gut damage, etc. We not only substantiate the overall effect of your ingredient on the human body, but provide you with a deeper understanding of the mechanisms of action. 

Any questions?

Ioana Iorga is happy to answer all your questions.

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