Functional ingredients firm Provexis has published the results of a new study providing further clinical evidence that its anti-thrombotic food ingredient could rival aspirin - without any side-effects.
Fruitflow is a tomato extract claimed to reduce the risk of blood clots, which can trigger heart attacks and strokes. It also has a significant advantage over many other ‘functional’ ingredients in that it has secured a coveted positive opinion from the European Food Safety Authority (EFSA) for its health claims.
Provexis is in talks with several big brands about incorporating Fruitflow into dietary supplements and functional foods and drinks, including Coca-Cola. It is also in discussions with a “major dairy brand owner” about using Fruitflow in other products after a tie-up with Unilever on spreads ground to a halt, said chief executive Stephen Moon.
In a stock exchange announcement, Provexis unveiled preliminary results of a human clinical trial comparing Fruitflow with aspirin. According to the results, Fruitflow had helped reduce platelet aggregation (part of the blood-clotting process that can cause heart attacks and strokes) by 28%. It did so through three different biological pathways, while aspirin showed up to 60% reduction in one of these pathways, but no effect on the other two.
The results were very encouraging, said Moon. “Aspirin is a drug that targets one specific platelet aggregation pathway, and is not recommended for use by the population at large for cardiovascular disease prevention partly due to its well known side-effects including gastric bleeding. In addition, a significant percentage of users show some resistance to its effects.
“The broader antiplatelet effect of Fruitflow reflects the company’s aim to provide a daily dietary supplement with a significant effect on blood flow, but without suppressing platelet aggregation completely.”
The trial compared the effects of Fruitflow and aspirin on a single dose basis over a five-hour time course. So far, around 40% of subjects have completed the trial, which will run until the end of the year. The trial is being carried out by Provexis at the Rowett Institute of Nutrition and Health, part of the University of Aberdeen, with independent statistical analysis by Biomathematics & Statistics Scotland.
The only difficulty was the issue of securing more consumer-friendly wording for the health claim about Fruitflow, said Moon. In its application to make a health claim, Provexis proposed that Fruitflow ‘helps to maintain a healthy blood flow and benefits circulation’. However, EFSA argued that the phrase ‘helps maintain normal platelet aggregation’, better reflected the scientific evidence.
Under article five of the Nutrition and Health Claims Regulation, claims are only permitted “if the average consumer can be expected to understand the beneficial effects as expressed in the claim”. That was obviously questionable in the case of platelet aggregation, said Moon. “EFSA’s wording is too medical. The average consumer hasn’t even heard of platelets.”