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‘Having a clinical trial on your formulated product can help you stand out from the crowd’ [Interview]

Article-‘Having a clinical trial on your formulated product can help you stand out from the crowd’ [Interview]

Dr Adrian Lopresti
Most companies base their product health claims on studies of one or two ingredients. However, they should ideally be conducting clinical trials on the finished product because combined ingredients may have greater potency, says Adrian Lopresti, clinical psychologist and researcher.

Australia-based Adrian Lopresti is a clinical psychologist and researcher whose work focuses on integrative treatments for mental health problems including psychological, lifestyle, nutritional, and herbal therapies.

As managing director of contract research organisation Clinical Research Australia, he conducts clinical studies on nutraceutical and natural treatments for mental and cognitive health. He has conducted several randomised-controlled trials on herbal and nutraceutical interventions for depression, anxiety and ADHD which have been published in peer-reviewed journals.

Lopresti will be speaking as part of the free-to-attend Vitafoods Insights Webinar Series on Brain health and mental wellness on 31 January. We caught up with him ahead of the event to find out more about this growing area of research.

What are some of the most important factors companies should consider when formulating products to support mental and cognitive wellbeing?

“There are several questions that formulators should ask themselves. Here are some that companies should consider: What symptoms or conditions do I want the product to treat? Which ingredients have robust clinical evidence supporting their efficacy in treating these conditions or symptoms?

If you are using herbal ingredients, [companies should consider] which specific herbal extracts have undergone clinical trials. If you are creating a multi-ingredient formula, what combination of ingredients should I include? How do they complement each other? And are there potential problems with the interaction between these ingredients that might affect the stability or efficacy of the product?”

A lot of research is being conducted to identify novel ingredients in this space. How can companies choose the best ingredient for their products?

“There are a lot of claims made in the natural space. However, many of these claims are not supported by robust clinical trials. Companies need to consider the quality of the study (randomised, double-blind, placebo-controlled trials are best), the condition or symptoms investigated, whether more than one trial has been conducted on the ingredient (more than one trial is better), was the sample size in the study large enough to make reliable claims, was the recruited population appropriate based on the market I am targeting? These are just a sample of questions.”

Would you encourage companies to only use ingredients that have approved health claims?

“When formulating a product, it is best to have at least one ingredient that has approved health claims. In an ideal world, companies should conduct clinical trials on their formulated product; however, I acknowledge that this may not always be feasible. Having a clinical trial on your formulated product can help you stand out from the crowd, because most products base their claims on the studies of one or two ingredients. What we don’t know is if the formulated product has greater potency when multiple ingredients are combined.”

In your experience, what are some of the most promising ingredients in this category that can deliver mental wellbeing benefits?

“There are many exciting ingredients with robust clinical trials supporting their efficacy. Some ingredients to support mental health include saffron, ashwagandha, curcumin, probiotics, and fish oil. B vitamins and magnesium are also important ingredients to support brain health. From a cognitive perspective, some ingredients include, bacopa monnieri, sage, blueberries, grapes, and gingko biloba.”

What other insights can webinar attendees look forward to during your presentation?

“In addition to a review of potential ingredients to support mental and cognitive health, I will also cover some of the biological mechanisms important for mental and cognitive health, and how natural ingredients can be used to optimise these mechanisms.”