The ingredient – dubbed ‘NM504’ – is now entering a human clinical trial in a powdered drink mix, Dr Dean Stull, chief executive at New Orleans-based biotech NuMe Health told NutraIngredients-USA.
“We’ve filed a patent application for NM504, which contains a combination of three GRAS (generally recognized as safe) ingredients. They are a standard prebiotic ingredient, an oat-based ingredient and a berry-based concentrate.
“The patent is a composition patent covering the specific ratio of the ingredients and its therapeutic indications. We’ll amend the filing when the results of the study are in.”
Human clinical trial just starting
The primary endpoints of the 30-day study, which is being conducted at Pennington Biomedical Research Center, Louisiana, will be ”insulin sensitivity, blood glucose levels and alterations in the gut flora”, he said.
“We’ll look at secondary endpoints like hunger and body weight because the ingredients we’re using are known to regulate gut hormones associated with satiety. But this isn’t a weight loss trial. It’s too short.”
He added: “There is a significant untapped opportunity to target the 79m people in America that are prediabetic with products that help increase insulin sensitivity and delay the onset of diabetes.
“People are being diagnosed with prediabetes now, so awareness is rising. We also know current methods of dealing with it - being told to exercise more and lose weight - are not working.”
As for what NuMe means by ‘cobiotic’, he said: “Cobiotics encourage the growth of good bacteria, discourage the growth of bad bacteria and help create an overall healthy microbiota environment in the GI tract.”
According to NuMe, its products will promote increases in Bacteriodetes microbiota and proportional decreases in Firmicutes microbiota.
The chief science officer at the firm (which was co-founded by Whole Foods Markets chairman John Elstrott and entrepreneur Dale Pfost), is Dr Mark Heiman, who spent 20 years at Eli Lilly working on endocrine-related drug discovery and development before joining NuMe.
Its mission is “to shift GI microbiome populations to favorably affect prediabetes by increasing insulin sensitivity, improving fasting glucose levels, increasing the production of satiety hormones, inhibiting the appetite hormone ghrelin, and making the body less efficient at absorbing calories.”
The business plan is to develop consumer products containing NM504, either directly or via a strategic partnership, said Stull. “We are not interested in being an ingredients supplier.”
“The first product is likely to be a low-calorie powdered drink. After that we are looking at several options including a 4-6oz liquid supplement product, soy milks, juices and waters.
“We want to help consumers with product fatigue - no one wants to take exactly the same thing every day - so we’re looking at multiple delivery formats.”
Prediabetes - a ticking time bomb?
According to the American Diabetes Association, prediabetes (elevated fasting blood glucose levels), is estimated to affect 79m or one in three American adults, and if unchecked, can lead to type 2 diabetes.
Several industry watchers believe prediabetes could be the next big opportunity in the functional foods and beverages market, although things have moved on since the low-carb, low-GI craze of a few years back.
One recent entrant to this market is Florida-based ATM Metabolics, which is in talks with some of the biggest food and beverage brands in the US and Europe about incorporating Emulin - an insulin-mimicking combination of plant-sourced chlorogenic acid, myricetin and quercetin - into packaged foods and drinks.
National Starch/Corn Products International (which sells a resistant starch called Hi-Maize) is also convinced by the opportunity, although it thinks ‘healthy blood sugar’ resonates more strongly with consumers than talking about ‘insulin sensitivity’.
Speaking to us last summer, Jeff Hilton, co-founder of marketing consultancy IMG, said: “Low-GI was a hot trend for a while, but consumers just didn’t get it. And as for talking about metabolic syndrome [in which insulin resistance is a key component] forget it.
"'Healthy blood sugar’ is a better way to communicate with consumers, although it will still take a lot of education. But I do think there is a huge potential in this market as so many people are pre-diabetic.”