Clinical trials can help companies meet growing consumer demand for ‘functional’ food and drinks. But while ‘health’ is the goal, these are not the same as pharmaceutical trials. What do you need to know to ensure a smooth, efficient and effective project that substantiates your product’s health benefits? 

We expect more and more from our food. In 2019, half of global consumers increased their consumption of ‘functional’ foods and drinks. There was a 34.5% increase in the number of sports nutrition products launched with an immunity benefit claim. And there were twice as many snacks launched with digestive/gut health claims than in the previous year. The foods we pick have become an important part of our life goals: to live longer, live healthier, live fitter… 

Standout from the crowd 

Which means functional health benefits continue to offer an attractive way for companies to add value to their food products – and to make them stand out on supermarket shelves stocked to the brim with a never-ending selection of food and beverages to tempt consumers. 

It’s a challenge, but more than that it’s an opportunity: to find or develop new ingredients, and then scientifically demonstrate their benefits to regulators and consumers alike. 

Essential validation 

Clinical trials form a key component in this approach. They allow manufacturers to identify new approaches to their products, and to answer questions such as: What new ingredients are available for human consumption? What nutritional qualities do they have? How do they affect health? What additional benefits do existing products have on health concerns such as resistance to infection? 

By testing the food or beverage ingredients on volunteers, we can assess the proof of concept, gain insight on the impact of an ingredient, collect evidence of a health benefit, characterise ingredients by their effects, and provide measurable outcomes to meet regulatory requirements. 

Food is not pharma 

With all of our years running clinical trials for food and beverage ingredients, we at NIZO have built up experience and understanding of some of the issues to keep in mind when you need to substantiate the health benefits of your product. 

Firstly, clinical trials for food and beverage ingredients and compounds are in many ways similar to pharmaceutical trials. For example, the study designs are similar, the quality assurance requirements are strict to protect study subjects and data integrity, study protocols are reviewed by medical-ethical committees, etc. 

However, testing foods raises some significant and unique challenges. In food trials, we are not looking to cure or treat a health condition. Instead, we are seeking to evaluate how the ingredient helps prevent or mitigate symptoms, or enhance performance, for example. That means, on the one hand, we need to carry out the trials on relatively healthy individuals. But on the other hand, to show a benefit, we may need to ‘create’ a stress factor for the volunteers. 

Unlike pharmaceutical compounds, foods generally have multifactorial effects, acting through several different mechanisms at the same time. The volunteers’ own diets can impact the study results, so that needs to be closely monitored. The results also should be analysed by scientists and professionals with an in-depth knowledge of ingredient properties and food matrices. 

On a very practical level, it can be more difficult to arrange a ‘blind’ test with a food product, than with an anonymous pill. And the food ingredient has to be provided in a form that the volunteers can ingest and which is palatable: so taste, texture, solubility, freshness, etc. need to be considered in a way that is mostly not an issue for pharma trials. 

Prepare for success 

With all of this to keep in mind, for a smooth, efficient and effective clinical trial, you want to work with a company that combines food, nutrition and health expertise. Make sure that the team responsible for your trial understands how food ingredients are digested and metabolised – and most importantly, what this means for the human body. But don’t forget the importance of food technology, processing and safety. And finally, work with a testing company that provides not just data, but interpretation, guidance and consultancy, so that you can make decisions informed by data, but driven by expertise. 

Any questions?

Alwine Kardinaal is happy to answer all your questions.

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