With health and wellbeing trending more strongly than ever, Produce Business UK takes a look at food clinical studies to investigate the potential to develop positive health claims for fruits and vegetables with a tangible return on investment
The food we eat alters the bacteria inside our bodies and while fruits and vegetables are naturally very good for us, eating them fresh is not the only way to reap their health benefits. This is where food clinical trials can help; by allowing food companies and sectors to identify, market and sell the bioactive substances in food that promote wellbeing.
“Eating a portion of broccoli a day will, of course, benefit you but if you find a bioactive ingredient in fresh produce that’s good for you, you could market that active ingredient or even sell it to another company or industry,” explains Barry Skillington, business development manager at independent clinical research organisation Atlantia Food Clinical Trials in Cork, Ireland.
Although the antioxidants in fresh produce are known to help the heart, brain and other parts of the body, Skillington says the food industry’s knowledge of functional food is actually low because not much research has been done to discover the inherent benefits of fruits and vegetables.
“There’s a lot more to dig into,” he points out. “In fruit and veg there’s historically been a lack of spend on research because growers are small, non-scientific and their focus is on shelf-life or packaging, among other things. They don’t have the time or the funds to look at research projects and I don’t blame them. Public funding tends to be limited too.”
However, at the same time Skillington notes there has been a huge spend on research in the dairy and drinks industries, which have led directly to a very high commercial return, and he feels fresh produce could be missing out on potential opportunity.
“Companies like General Mills and Coca Cola are always doing research because they have the cash flow,” he says. “For example, stevia, which is extracted from the leaves of the plant species Stevia rebaudiana, is already being used as a natural sweetener and sugar substitute in Coca Cola Light.”
Once food trials have started, Skillington says businesses are “fantastic at rooting out the commercial benefit”. For instance, he says a lucrative bioactive ingredient found in produce could be sold to the yoghurt industry or to manufacturers of gym supplements and sports nutrition drinks, who have really upped their game in terms of flavour and performance.
“Many companies sell on their health claim, in other words they sell the rights to the ingredient or the technology to extract the ingredient and they make money that way. They may sell the ingredient for others to use in other products and make money off the back of that.
“There’s a huge amount of scope for the produce sector but what also puts off growers is they’re not scientific themselves and the word ‘trial’ scares them,” Skillington continues. “But although the tests are run on humans it’s not a drugs trial, so there are no adverse reactions to be concerned about. The humans are all healthy, they volunteer and they are paid but the most they may encounter is a headache or an upset stomach.”
Testing fresh produce
Atlantia Food Clinical Trials is a specialist company that helps companies worldwide to prove food, beverage and supplement health claims by running clinical trials on bioactive substances – the active peptides or molecules in food – that have a benefit for health, such as digestive, cardiovascular, sports performance, mental health, healthy ageing, immune and inflammatory health, oral and nutritional health.
The only real common thread in Atlantia’s work is that the products tested are derived from food – either in their natural form or their concentrated form, i.e. the bioactives in fruits and vegetables.
Indeed, Skillington says you would never really test fresh produce per se, rather it has to be a processed version because it needs to be in a format where its shelf-life will last in a pharmacy or shop. “For example, the botanical extracts from fruits and vegetables can be used as a medicine or a non-food and these are both perfectly viable routes to market,” he explains.
There are already some products with health claims on the market that are derived from fruits and vegetables. “The actives in beetroot have been found to aid sports performance and recovery,” says Skillington. “Sportsmen are now drinking a powdered form of beetroot in sports drinks for its beneficial effects.”
Channel 4 programme Food Unwrapped has carried out its own investigation into whether beetroot can improve physical performance. Featuring Professor Andrew Jones from Exeter University, in one episode presenter Kate Quilton had her stamina tested on a bike across two separate sessions. In one, Quilton was given a Beet It Sport shot while in the other session she received a nitrate-depleted placebo.
After consuming the Beet It Sport shot Quilton managed to cycle for an additional 30 seconds, which Professor Jones claimed was “a 4% increase in performance”, and consistent with “what we’ve shown in some other studies using this exercise”.
Incorporating seaweed in the human diet has benefits too – it could help reduce iodine insufficiency – a current problem in the UK and around the world, according to a University of Glasgow study. “This study shows that seaweed offers a way of addressing iodine insufficiency in a healthy, palatable way,” explains Dr Emilie Combet, who led the research.
“Seaweed could easily be added to staple food groups with no adverse effects on taste. However, caution must be exercised – not all seaweeds are the same, with some containing too much iodine, or heavy metals.”
At the moment, Skillington reveals there is a trial running on an extract from kiwifruit which looks promising in terms of its cardiovascular benefit, while other trials are looking into extracts from various berries in an effort to help with weight control.
He says there are also companies in Ireland carrying out bioactive mining – taking botanical extracts, distilling them and testing them in vitro to see if they have an effect on human cells. If successful, those extracts are being researched in animal trials and human trials. “Testing is going on worldwide and the financial return is quite big,” Skillington explains. “Monaghan Mushrooms in Ireland is looking at this for mushrooms.”
Already, Monaghan claims to be the first mushroom company in Europe to launch Vitamin D mushrooms. Grown and packed at its County Monaghan farm, they taste just like regular mushrooms, but have the benefit of providing 100% of the recommended daily amount of vitamin D in just three mushrooms, according to the European Food Information Council.
“Monaghan Mushrooms has introduced a new process to enhance the vitamin D2 content in mushrooms by mimicking the production of vitamin D2 that occurs in mushrooms exposed to sunlight in their natural environment [compared with commercial mushrooms that are generally grown in the dark],” a company spokesperson explains.
“We give the mushrooms light and though a natural process they make vitamin D, just like wild outdoor grown mushrooms. Our Vitamin D mushrooms are currently sold in selected stores in Marks and Spencer stores in Ireland and the UK.”
Skillington believes the fresh produce industry has not advanced as much as it could have due to a lack of patents. “A lot of work has been done on Beneforté broccoli,” he muses. “It’s high in antioxidants so there are pulmonary and immunity benefits. But that’s a specific type of broccoli, so who wins? It’s probably the seed company who will see the commercial benefit.”
You therefore need something that’s protectable or patentable, according to Skillington. “Maybe you have a specific raspberry variety that is unique to you that you own,” he says. “Otherwise, you do the research and it’s just a gift for the world to market.”
Getting a trial off the ground
To begin a food clinical trial you need three things, according to Skillington. Firstly, a notion of what benefit your product has, secondly the money, and thirdly the intent. “Companies might be at various stages of their findings but you have to have an idea of what the health benefit is,” he states. “You can have promising evidence already, of course. You just need to come to us with something tangible.”
Skillington says there is no benefit unless a company approaches an organisation like Atlantia with a good notion that their product is high in a vitamin, mineral, flavonoid, antioxidant or even a carbohydrate which can be used as a prebiotic. “Companies need to guide us in what they want to find because everything you test costs you money,” he points out. “If you don’t know, it would be better to approach a commercial laboratory to find a starting point.”
Finding tangible evidence
It’s well known there are plenty of flavonoids in berries, cocoa and teas. Carotene in carrots has always been of interest because of the benefit for retina cells and eyesight. The mulberry leaf has also been found to help with weight management and controlling blood sugar levels, and berries in general can be good for helping diabetics stem spikes in their blood sugar levels. Skillington says even the lycopene found in the skins of tomatoes is being looked at again.
In general, there’s a lot of information already readily available about the bioactive ingredients in food. “Google is fantastic for doing general searches on trials,” suggests Skillington. “PubMed [a free resource developed and maintained by the US National Center for Biotechnology Information] is another great source of information. The National Institutes of Health (NIH) in the US does a lot of research that’s in the public domain too. The Food Safety Authority of Ireland and the Food Standards Agency in the UK also offer information.”
Skillington also recommends approaching a university for some funding to carry out research which would provide the necessary information to indicate whether it’s worth investing more in trials before going on to a clinical human trial.
“Growers usually go to a publicly-funded university for a innovation token that provides £5,000 to spend on investigating the feasibility of investing in research further down the track,” Skillington explains.
“You can find out what your product is high in and get all the information broken down. For instance, you may find that sea kale is high in selenium, which is good for the heart. You could even just use that information to encourage more people to eat the vegetable in its fresh form via messages that are backed up by your findings.”
Financing is not as difficult as it may seem
Atlantia’s trials generally last 12 weeks, and the administration required before and after the timeframe is usually six months. Costs run from anywhere between £80,000 to £1 million although they generally fall within the £120,000-200,000-mark.
While the cost of research may seem out of reach for many growers and suppliers, Skillington says there are cost-effective avenues to explore which could lead to lucrative marketing opportunities.
“You can have collaborative trials,” he recommends. “As a grower you could appeal to an association of your specific product and then if you’ve found a health claim all the growers will benefit when the market rises. Consortiums running trials are quite common. We’ve worked with a lot of competing companies as a group and they share the information at the end.”
Skillington also urges produce growers to put more pressure on academics and local government for funding. “Food Dudes [an award-winning scheme for schools based on behaviour change methods around healthy eating and preventing childhood obesity] is a great programme but there’s so much more that we can do,” he proposes. “The labs are here and ready it just takes the money.
“The industry needs to pressure the government and state agencies; lobby for funding to get research into produce off the ground. Ireland is now a leading producer of protein for infants (because of the way the cattle is raised) and that all stemmed from research done by a governmental body. The Horizon 2020 programme, for instance, is offering a lot of research funding for the greater common good and there is there is probably some produce research already under way.”
Horizon 2020 is the biggest EU research and innovation programme ever with nearly €80 billion (£58.5 billion) in funding available over seven years (2014 to 2020). Its aim is to secure Europe's global competitiveness through breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. Within the programme, there is a specific focus on food and healthy diets via research that aims to generate new knowledge and innovation.
Find out how to access funding under the Horizon 2020 programme here.