No longer an isolated category, experts agree glucose maintenance is a “building block” that should be part of any health maintenance strategy.

Diabetes prevention has become a major public health investment since 350 million people are currently living with diabetes, among which 90 percent have type 2 diabetes, a chronic but preventable disease, according to the World Health Organization.

“There is a worldwide public educational campaign underway to help teach people how to live a healthier lifestyle and emphasize the importance of losing weight, exercising and having a healthy diet low in sugar and fat to decrease their risk,” noted Thomas Ughetto, deputy director Business Unit Nutrition and Health with Naturex Inc. in New Jersey. “Balancing blood sugar levels and decreasing them when they are too high is one of the key issues to improving health. Food supplements can help to regulate blood sugar levels. Though the food supplement offering in this market segment is currently limited, the market potential is huge,” he said.

Steve Siegel, vice president of New jersey-based Ecuadorian Rainforest, LLC, agreed, and said the market for products and ingredients that address healthy blood sugar has never been better. “Those purchasing products to maintain healthy blood sugar levels are mainly diabetics and that’s a great market to tap into.” He pointed to a report published by Transparency Market Research, which stated that the diabetic food market is believed to grow up to 9.9 percent by 2018, and is estimated to be worth $98.4 billion by then. “So, if you are preparing a product for healthy blood sugar, there has never been a better time to enter the market than now.” 

It should come as no surprise that Americans are at great risk to be a part of those statistics. “About 70 percent of Americans are classified as either overweight or obese, which significantly increases the risks for metabolic syndromes and other medical disorders, such as diabetes and heart disorders,” said Sandy Chien, PhD, vice president of innovative products with Californiabased HORN Nutraceuticals. “Blood sugar management addresses the bottom line of weight management— excess glucose being stored as fat. Blood sugar management is the key not only to address the weight issue itself, but also help to reduce the potential health risks that are associated with weight gain. More and more people are becoming aware of the importance of healthy blood sugar that it is not only related to diabetes, but also overall health and weight.” 

With the staggering costs of diabetes known, it makes great sense to formulate natural-based products, both supplements and foods and beverages to help stabilize healthier blood sugar response, said Mitch Skop, senior vice president new product development, with Pharmachem Laboratories Inc. in New Jersey. “But we must caution against making any claims of disease states prohibited by the Food and Drug Administration (FDA),” he said.

An Evolving Market

Jocelyn Bérubé, Msc scientific director, Health and Nutrition with Canadabased InnoVactiv, noted that the consensus has been growing for years among experts about the importance of maintaining post-meal blood sugar levels within a healthy range. “But more specifically in the past year, we have seen a clear evolution in the blood sugar market,” he said. “We now see formulators really understanding that blood glucose maintenance is a ‘building block’ that should be part of any health maintenance strategy, from weight loss to heart health to hormonal balance and so on. We also see a shift from formulators, moving away from single ingredient formulations toward multi-faceted approaches containing various ingredients allowing for a more complete approach to various health concerns.” 

And while food supplement offerings to manage blood sugar is still limited right now, there are a lot of ingredients available for this purpose on the market, said Ughetto. “It is important to note that many blood sugar-lowering ingredients work either by stimulating insulin production, which can cause insulin resistance, or by reducing the absorption of carbohydrates, but these are ineffective when you eat simple sugars (glucose, fructose, galactose), such as sodas or fast food.”

“Consumers have more knowledge of their foods now than any other time in history,” Siegel added. “New studies are coming out regularly studying the effects of natural foods to help with glycemic control. For example, barley has been making new breakthrough in the market. According to a study done by the University of Tokushima, researchers noted that the subjects who had barley instead of rice showed lower glucose levels after a meal. Now consumers have a choice in how to better control their glucose levels and they are getting more options every day.” 

There are many different ways to manage blood glucose, such as ingredients that can increase insulin production via beta cells in the pancreas, or increase cell sensitivities and reduce insulin resistance or increase the uptake of glucose from the plasma and store them as glycogen, said HORN’s Chien. “However, there is a more direct way of helping address glycemic control is to block the breaking down of carbohydrates and prevent the fast and immediate release of glucose into the blood,” Chien noted. MealShape is an innovative starch blocker, exclusively available in North America through HORN, which is clinically proven to instantly reduce 20 percent of glycemic index of any starchy food.

Another new offering is Glucevia developed by Naturex that works mainly on the liver and can reduce the peak of glucose normally observed after a sugar-rich meal, according to Ughetto.

Joseph O’Neill, president and general manager of New Jersey-based BENEO, Inc. said the company offers two options to minimize a food’s glycemic effect: Modification of glucose supply by choosing e.g. low glycemic available carbohydrates such as Beneo’s Palatinose; and reduction of glucose supply by replacing fully available carbohydrates by prebiotic fibers such as oligofructose and inulin or sugar replacers (polyols) such as ISOMALT.

“The first option is to modify the glucose supply in a way that the carbohydrate energy enters the body in a slow, low and sustained way,” said O’Neill.

According to the company, Palatinose has a unique physiological profile that helps support healthy nutrition and blood glucose management in new product formulations. Its chemical structure is classified as a sugar. However, as Palatinose has a combination of physiological properties, it is actually a lowglycemic and thus, “good” sugar.

The second strategy involves substituting fully available carbohydrates by partially available ones, which leads to a reduction of glucose supply and thus to lower glycemic and insulinemic responses. For example, fully available carbs can be replaced by non-GMO (genetically modified organism) dietary fibers such as inulin and oligofructose, ingredients that are naturally derived from the chicory plant. The nondigestible, all-natural chicory fibers are ingredients of choice, having both physiological and technical properties. Having a mild sweet taste and being highly soluble, the replacement of sugars is technically feasible with excellent sensorial results and will lead to a final product with a lower blood sugar profile. This means enrichment with dietary fibers can assist consumers in closing the so-called “fiber gap” and help maintain healthy blood sugar levels.

A challenge in the blood sugar category is facing the lack of immediate “feeling” of a beneficial action by the user, said Bérubé. “Unlike products like energy boosts that you can feel acting, the benefits of improving blood sugar control will appear in the long term,” he noted. “Very rarely do we feel anything when our blood sugar goes out of bound, especially in hyperglycemic range where most long-term damage occurs. Users of blood sugar products are thus more likely to give up their supplementation if they experience any side effect like intestinal troubles, because the benefit does not stand out as clearly as it should.” 

This hurdle has been at the core of the development of InnoVactiv’s ingredient InSea2. “Our objective was to find an ingredient that would be effective in slowing down carb digestion and assimilation, while yet being safe and well tolerated,” Bérubé added. “By targeting alpha-amylase and alpha-glucosidase, InSea2 can achieve superior control over post-meal blood sugar and insulin responses, while having no adverse impacts on the gastrointestinal tract.”

Seeking Innovation 

The key to true innovation in this category is to find ways to help manage blood sugar from a variety of angles, always keeping in mind that the strategies that have the most profound impact on long-term health are those that help reduce the total amount of insulin needed after a meal, said Bérubé. “In fact, approaches that induce a lowering in blood sugar by increasing insulin secretion should not be used, as they basically increase the very cause of high blood sugar levels: the decrease in insulin sensitivity,” he noted. “A solution that would improve control over post-meal blood sugar levels, while simultaneously reducing postmeal insulin and sustaining insulin sensitivity would benefit most to users, in my opinion.” 

A challenge for suppliers, according to Ughetto, is that the blood sugar category lacks real innovative ingredients with proven efficacy. “This segment represents a big part of the market (specific figures on this category are usually classified under the cardiovascular prevention category or diabetes category). Looking at the increasing incidence of diabetes, we feel that this category will grow quickly in the coming years,” he predicted.

“While there are few branded ingredients out there, the market is dominated by generic ingredients such as alpha lipoic acid, chromium, and cinnamon, gymnema, fenugreek and licorice,” Ughetto added. “This is mainly because the scientific evidence of efficacy associated with branded products is limited. It is clear that more work needs to be done by suppliers to build momentum.” 

But manufacturers are really listening to their customers now, Siegel said. “They focus their energy into creating natural foods products with pure ingredients, something many consumers have been asking for. Those manufacturers are now addressing concerns for those who need a hand managing their blood glucose levels.” 

Ingredient Science 

Among several studies conducted by Pharmachem, Skop noted a 2010 study in the peer-reviewed publication, The Open Nutraceuticals Journal, which describes two double-blind human pilot studies demonstrating the ability of the company’s Phase 2 Carb Controller product, a standardized extract of the white bean, to decrease glucose absorption.

The article, “Investigation of an Amylase Inhibitor on Human Glucose Absorption after Starch Consumption,” by Vinson et al, concluded that “the bean extract has in-vivo efficacy for inhibition of starch absorption, and may prove beneficial in weight reduction in individuals consuming large amounts of starch. It also may inhibit starch-induced hyperglycemia in normal and diabetic subjects.” 

In study 1, when participants consumed four slices of white bread and margarine with or without Phase 2, glucose absorption, as measured by the area under the plasma glucose time curve, was inhibited by 66 percent in the Phase 2 group. Accordingly, only one-third of the carbohydrates in the bread were absorbed. In addition, the glucose returned to baseline earlier than the control.

In study 2, subjects who consumed a carb-laden frozen dinner with or without Phase 2, demonstrated that the Phase 2 group had an earlier return to baseline and that approximately 40 percent of the carbohydrates were inhibited from absorption.

At Naturex, three studies, one clinical trial and two pre-clinical, linked to Glucevia were published in 2014. “They are therefore very recent and have raised a lot of interest since we introduced the product on the market a few months ago,” Ughetto said.

“When you talk about ash tree, usually you refer to its leaf,” he continued. “The ash tree leaf is well documented and traditionally used for its diuretic and anti-inflammatory properties in joint health. Naturex has explored the properties of ash seeds that are lightly documented but known for being used mostly in the Mediterranean basin for their blood glucose lowering property. We wanted to further investigate this property. Through our research department’s three-year investigations in-vitro and clinical trials, we were able to further demonstrate ash seed’s efficacy and mechanism of action. We developed and patented a new ingredient that responds to a major public health issue: lowering blood sugar level.” 

Ughetto said using Naturex’s extraction process, the company developed the ingredient, standardized for the first time to 10 percent Nuzhenide and GI3. These actives have been discovered and isolated by Naturex and are mainly responsible for the effect of the product. The extract has been clinically studied and has shown significant results for blood sugar reduction following meals. 

Of Glucevia’s two clinical studies, the first one was an acute double-blind, randomized, crossover, placebo-controlled clinical trial on 16 healthy people and showed Glucevia immediately reduces the incremental glucose area under the curve (AUC) by 8.8 percent, compared to placebo (Visen et al. (2009) J. Ethnopharmacol, 126:226- 232) . This result was then confirmed in a recent and chronic double-blind, randomized, cross-over (21 days for each arm), placebo-controlled intervention study with one week wash-out between arms on 17 people. Incremental glucose AUC was significantly reduced by 28.2 percent following three weeks of administration of Glucevia (Zulet et al. (2014) Phytomedecine). In-vivo studies also confirmed the effect of ash seed to reduce post prandial glucose levels.

More recently, a study on diabetic rats showed that Glucevia significantly reduces fatty liver by 82 percent in the active group compared to the placebo group (Vilaplana et al. 2014). This suggests Glucevia may ensure the maintenance of a normally functioning liver.

In 2014, following collaboration coordinated by BENEO, a dossier for E. U. Art 13.5 claim was filed containing new information linking the prebiotic fiber oligofructose with improved blood glucose response after intake. The research provided additional physiological evidence as to why oligofructose is a very suitable sugar replacer and thus presents new opportunities for the food industry to meet consumer demands for more low-glycemic and tasty products.

This proprietary new research shows the positive impact on blood glucose response when a proportion of the sugars in a product are replaced with oligofructose, which is a non-GMO prebiotic fiber derived from chicory.

The dossier submitted to EFSA (European Food Safety Authority) opens the door, therefore, for new food and drink applications to benefit both the industry and consumers, according to O’Neill.

For HORN, in March of 2013, a randomized, crossover, double-blind, placebo-controlled clinical study on 18 healthy subjects was conducted in France and demonstrated that MealShape lowers postprandial glycemia by 21.2 percent after a standard meal. Additionally, MealShape has also been the subject of several preclinical trials in rodent models, demonstrating complete safety and efficacy. The study results were recently published by BMC Alternative and Complementary Medicine.

Independent studies of postprandial glycemia reduction show long-term benefits for metabolic syndrome. MealShape’s approach to postprandial glycemia reduction offers potential global health benefits for diabetes, cardiovascular health and weight management.

And it is exactly those health topics that Skop said this category is closely and intimately entwined with. “We believe that blood sugar support should no longer be isolated,” he concluded, “as the medical community is clearly conveying to patients that when conditions of pre-diabetes or metabolic syndrome exist, the patient needs to be cognizant of his or her cardiovascular status, as well as try to attain a healthy BMI (body mass index).”

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