Clinical proof of efficacy provides further recognition of Phynova’s Reducose® as a functional ingredient to promote healthy blood sugar
Phynova, the British innovative life science company that develops and markets proprietary drugs and functional food ingredients derived from active plant compounds, is pleased to announce that its natural plant-based food ingredient, Reducose®, has further demonstrated its effectiveness at maintaining healthy blood glucose levels in a clinical trial run in conjunction with the University of Southampton and Oxford Brookes University. The trial was a randomised, double-blind, placebo controlled, dose-ranging study in healthy individuals that investigated the effectiveness of three doses of Reducose® on lowering blood glucose and blood insulin responses after the ingestion of carbohydrates.
Reducose® is a patented natural functional food ingredient that is derived from mulberry leaves. It can be incorporated directly into foods and drinks and promotes healthy blood glucose levels by inhibiting sugar being absorbed by the body. Reducose® is not a sugar replacement so foods do not have to be reformulated and they retain the taste consumers prefer. Reducose® could also be developed as a food or dietary supplement for sale directly to consumers or via pharmacies.
The study, which was funded through an Innovate UK grant, demonstrated that Reducose® significantly suppressed total blood glucose and insulin rises after ingestion of dietary starch in healthy adults, helping to maintain healthy, lower blood glucose and insulin levels. Furthermore, the study found that Reducose® is well tolerated with no statistical difference in gastrointestinal symptoms between any dose of Reducose® and the placebo. This research, together with Phynova’s innovative approach to making foods healthier, was recognised at the end of 2016 with this research being shortlisted as one of four finalists in the annual Innovate UK SME Innovation Awards at the Houses of Parliament.
Reducose® has already achieved GRAS (“Generally Recognized as Safe”) status in the USA, which allows it to be added to a wide variety of food and drink products.
Dr Mark Lown, lead author and clinical investigator, said: “It has been estimated that as much as a third of the UK population are prediabetic, where blood sugar levels are higher than normal but not high enough to be classed as diabetes. Excess calories from sugar and carbohydrate can increase the risk of developing diabetes. The results of this study are positive and suggest that this herbal extract may have a role to play in regulating blood sugar levels. Further studies are required to evaluate the long-term effects.
Robert Miller, CEO at Phynova, said: “I am extremely pleased with the positive results of this clinical trial which confirmed the benefits of Reducose® for helping people maintain healthy blood glucose levels. This is a remarkable milestone in Phynova’s mission in promoting healthy lifestyles. There is a global opportunity for the Company and Reducose®, and following achievement of GRAS status in the USA, we are anticipating further regulatory approval in China where there are almost 500 million pre-diabetics*.”
The findings of the study are now published on PLOS ONE, the world’s first multidisciplinary Open Access peer review journal:
*Source: Yudkin & Montori. The epidemic of pre-diabetes: the medicine and the politics. BMJ, 2014: 349.
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About the Research
This was a high quality double blinded, randomised, repeat measure, phase 2 crossover trial designed to study the glycaemic and insulinaemic response three doses of Reducose® mulberry versus placebo following a carbohydrate challenge. The study was led by investigators from University of Southampton Medical School and run in conjunction with the Functional Food Centre, Oxford Brookes University, UK. For the purpose of this study, a sample size of n=30 participants was estimated to provide over 90% power to detect a significant effect, based on a recent unpublished phase 1 study.
A total of 37 participants, aged 19-59 years with a BMI ≥ 20kg/m2 and ≤ 30kg/m2, completed the study. The primary objective was to determine the effect of three doses of Reducose® mulberry-extract (125mg, 250mg, and 500mg Reducose®) versus placebo on blood glucose responses (over 120 minutes) when co-administered with 50g maltodextrin, a dietary starch with high glycaemic index, in normoglycaemic healthy adults. Secondary outcomes were to test the insulin response (over 120 minutes) and gastrointestinal tolerability of the mulberry extract. The exact dosage regime was previously determined by a series of phase 1 studies carried out on normal healthy adults by Phynova.
The study found that mulberry leaf extract suppressed total glucose and insulin rises in normoglycaemic individuals without significant side effects. Reducose® also demonstrated a classical dose response curve with significant effects over placebo. Moreover, there were no statistically significant differences between the treatment groups in the odds of experiencing one or more gastrointestinal symptoms and that there was no increased incidence of gastrointestinal side effects.
For the full paper of this study, please visit: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0172239