Assessing foods’ impact on human health via clinical trials

Consumers are actively supporting gut health and recognize and choose food items which could positively affect the digestive system. Immune system support is another area of consumer interest, and this trend has grown significantly with the outbreak of COVID-19. It is also known that dysbiosis (unbalanced gut microbiome) can lead to immune dysregulation; therefore, gut health and a healthy immune system are linked. Thus, understanding and modulating the gut microbiota (microbiome) through diet has the potential to positively affect and promote consumer health.

To address the need for dietary solutions for gut and immune health, manufacturers are investing in research and development for new and healthier products. However, before such products reach the market as "healthy for your gut and immune system", their true benefit needs to be demonstrated. Contrary to drug trials, it is more challenging to show a cause-and-effect relationship of one food or food component on a specific health parameter against a background of constant food intake in the daily life. In addition, as benefits must be demonstrated in generally healthy subjects rather than patients with a specific disease, often study designs need to be capable of picking up more subtle improvements. And as per the general scientific guidance on health claim applications of EFSA, "pertinent human studies are an absolute requirement for scientific substantiation of health claims." 

When it comes to assessing the impact of food on human health, double-blind, placebo-controlled, randomized control trials (RCTs) are considered the gold standard and are preferred for their most rigorous approach—designing such trials includes many aspects that need to be carefully considered (e.g. type of study design, selection of target population, choice of endpoints and appropriate controls, the outcome assessment, etc.). Together with any supporting evidence on a possible mechanism of action, results of human intervention studies are then submitted to EFSA as part of a health claim dossier for review and evaluation. Publication of the study results in a peer-reviewed scientific journal is encouraged and can support the communication of product benefits to consumers. It is a lengthy process, and it is often not sufficient to grant the label on the market. And yet, it is still the best approach to prove that a food or a food component does indeed improve the gut or immune health.

How to successfully reach this goal? What can be improved? What are the challenges? Can understanding the microbiome help? Can challenge studies be useful?

These and many more questions will animate our roundtable discussion during Vitafoods Insights Virtual Expo on 11 May 2021 at 14:30 BST.

Learn more and register for free to attend the Vitafoods Insights Virtual Expo.