Vitafoods Insights is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

From pharma to food: The role of clinical trials in the functional ingredient space

Article-From pharma to food: The role of clinical trials in the functional ingredient space

© AdobeStock/momius From pharma to food: The role of clinical trials in the functional ingredient space
Double-blind, placebo-controlled clinical trials can help brands ensure their functional ingredients are backed by science and their claims are validated – but can industry-funded clinical trials be free from inherent bias?

Speaking at Future Food Tech in London last month, the CEO and founder of Irish company Nuritas, Nora Khaldi, said clinical trials were “the only way” for functional ingredient suppliers to back up their claims.

“The proof is in the pudding,” she said. “You have to do your clinicals [and] ingredients have to have the clinical backing behind them – products potentially, too. But at least from an ingredient perspective, you have to have clinicals run in a double-blind placebo manner like any clinical that is properly run, like the pharma-type clinicals.”

Nuritas has run almost 20 double-blind, placebo-controlled clinical trials on its different ingredients, Khaldi said. In one trial, it tested a sports nutrition muscle ingredient by putting individuals in casts to create muscle atrophy and then taking biopsies from those who had consumed its ingredient and those who had not.

“It’s the only way that you can support that this ingredient actually does what it [says] on the packaging, that the claims are supported,” Khaldi said. She added that she has noticed an uptick in the number of companies interested in only using ingredients that have been validated by clinical trials.

Collecting data points for meaningful validation

Nulixir is a US startup making nanovesicles for functional ingredients that allow for delayed release, extended release, and stage-wise release to improve bioavailability. All its products are independently tested for potency, purity, and consistency, according to its website.  

There’s a very big gap between the type of claims that you see in pharma versus what you see in food and beverage,” said Ehsan Moaseri, CEO and founder. “Your point of contact in pharma is a subject matter expert: it’s a doctor who’s going to start prescribing that medicine. But your point of contact in the [consumer packaged goods] CPG world is the consumer. They have heard some stuff and they think they know what they’re talking about, but sometimes you see that [the] knowledge is very shallow.

“… [T]hat’s where we try to come into play, to bring that level of calibre we have in pharmaceuticals, so it’s not just a nice claim that you want to put on your label, but you actually have the data points to back it up in a deeper, meaningful way, such as [in] pharmaceuticals.”

The use of wearable devices to demonstrate effect

The use of wearables could help the functional food and nutraceutical industry overcome a fundamental problem: that people may not necessarily feel the effect of taking their products even though they may well be benefiting from them.

Feeling the effect is important for repeat purchasing – particularly for products such as supplements in capsule form that do not taste good. An individual may well buy a superfood smoothie for the first time because of the health benefits and continue doing so because it tastes good, but this is less likely to happen with capsules and pills. Wearable technology can therefore tell users in real time if the product is working or not.

Nuritas has been incorporating wearable devices into its clinical trials to allow it to track the impact of an ingredient on clinical biomarkers. Participants in one of its ongoing trials for an ingredient that can be added to sugar-sweetened products to reduce the glucose peak in real time are required to wear continuous glucose monitors, for instance.

© AdobeStock/sitthiphong The role of clinical trials in the functional ingredient space

It also partnered with Oura ring, a wearable device that measures sleep parameters, to validate one of its ingredients that is aiming to compete with melatonin for sleep health and quality.

Industry research and the funding effect

Khaldi stressed the importance of running clinical trials that are “to standard”, adding that Nuritas’ clinical trials are developed by professors globally who work in both the pharma and medical food fields.

However, some commentators maintain that industry-funded studies are inherently biased. Marion Nestle, a prominent food industry critic and emerita professor of nutrition at New York University, often calls out bias in such research on her Food Politics blog.

According to Nestle (who was not part of the Future Food Tech panel), it is common in the food and nutraceutical industry for trade associations to request research proposals that specifically set out to demonstrate the favourable impact of a product or ingredient, rather than ask open-ended questions about its effects.

Even scientists running well-designed studies can unconsciously produce biased results, she says.

“If I see a study titled ‘Effect of food product X on disease Y’, I can often guess that the food’s manufacturer or trade association paid for it [and] the study outcome will be favourable to the funder’s commercial interests,” she wrote in July this year. “This phenomenon is so systematic that it has a name: The Funding Effect.

“Researchers who study funding effects, and there are many, note that the scientific conduct of the studies is not usually an issue. Instead, the influence of the funders shows up in the way the research question is framed or the results are interpreted.”

She concluded: “Industry funding biases research. But funded investigators do not recognise the influence and deny it.

“The statement that accompanies many disclosure statements – ‘The funder had no influence on the design, conduct, interpretation, or publication of the results’ – is often untrue and must be taken with some degree of scepticism.”