Sean Moloughney, Editor03.01.16
Blood glucose is a critical measure of health. However, millions of people are failing this wellness test, as the high prevalence of pre-diabetes and diabetes around the world continues to plague society.
Diabetes is one of the largest global health emergencies of the 21st century, as noted by the International Diabetes Federation’s (IDF) “2015 Diabetes Atlas.” In addition to the 415 million adults who are estimated to currently have diabetes worldwide, there are 318 million adults with impaired glucose tolerance, which puts them at high risk of developing the disease in the future. By 2040, IDF estimated 642 million people around the world could have diabetes.
In the U.S., an estimated 29 million people have the disease, 8.1 million of whom may be undiagnosed and unaware of their condition. In terms of new cases, 1.4 million Americans are diagnosed every year. In 2012, 86 million Americans age 20 and older had pre-diabetes, up from 79 million in 2010.
People who have diabetes are at higher risk for serious health complications, including kidney failure, heart disease, stroke, blindness and peripheral neuropathy. Ultimately, risk of death for adults with diabetes is 50% higher than for those without the disease.
The economic impact on society is also sizeable. Total costs of diagnosed diabetes cases in the U.S. in 2012 were $245 billion ($176 billion for direct medical costs and $69 billion in reduced productivity), according to the American Diabetes Association.
Healthcare costs continue to increase, according to IDF, with 12% of global health expenditure dedicated to diabetes treatment and related complications that account for the majority of the total costs.
Cause & Effect
As reported in the recent 2015-2020 Dietary Guidelines for Americans (DGA), people are consuming higher amounts of calories and refined, processed foods than they should, said Santiago Vega, senior manager of nutrition marketing, Ingredion Incorporated, Bridgewater, NJ. “The DGA Expert Committee indicates that Americans are consuming roughly double the amount of sugar that is recommended to maintain a healthy diet. This is happening in combination with high consumption of foods that contain large amounts of fats, refined flours and other processed ingredients that contribute to increasing blood sugar levels and weight gain. Add to this a sedentary lifestyle and the problems become exacerbated.”
Many people simply don’t understand how high their risk is, according to James LaValle, clinical pharmacist, board-certified clinical nutritionist and author of Your Blood Never Lies.
“We’ve known for quite a number of years that as people start to have elevated blood glucose their risk of diabetes increases.” But a study published in 2008 found that for every point above blood glucose level of 85 mg/dL a person’s risk for developing diabetes increases 6%. This means by the time they reach a level of 94, their risk increases by more than 50%; by the time they reach 99, that risk has increased by nearly 100%.
“Why is this important? Because these are numbers that are technically still in the normal range, but it’s ‘high-normal’ and it means increased risk. People could be doing something, but they don’t even understand that they are at risk. If you don’t get that message and you don’t do something to intervene, the next step is called pre-diabetes, which is the 100-120 mg/dL blood glucose range. People who enter this level have what is called ‘impaired glucose tolerance,’ and 70% of the people in this range will go on to develop diabetes.”
Ultimately, modern diets are leading the public down a deadly road, as many consumers struggle with the long-term effects of their eating habits, noted Jon Peters, president, BENEO, Inc. Morris Plains, NJ. For example, too many diets consist of large amounts of high glycemic carbohydrates like glucose, sucrose and maltodextrin.
“The clinical manifestation resulting from an individual’s unsuitable diet only becomes noticeable after doing small things wrong for a long period of time,” said Mr. Peters. “Human blood glucose regulation is a sensitive system that might become imbalanced over time if challenged constantly by high glucose loads that need to be regulated.”
The challenge consumers face when maintaining blood sugar and diabetes is that blood sugar levels change—sometimes unexpectedly, noted Sébastien Bornet, vice president of global sales and marketing at Horphag Research (exclusive worldwide supplier of Pycnogenol), Hoboken, NJ. “In addition, food additives, such as sugar and carbohydrates are sneaking into food more and more, making it difficult for consumers to easily pinpoint foods with high levels of certain ingredients, like sugar and carbohydrates.”
Persistently elevated concentrations of glucose in the blood negatively affect the health of blood vessels, the heart and nerves, said Nicolas Meyrial, vice president of sales & business development of Frutarom Health BU for North America. “Even more alarming is the increasing incidence of children and adolescents with type 2 diabetes showing signs of complications.”
There’s a misconception among the general population that managing blood sugar is an isolated idea that only applies to people with diabetes, said Paul Dijkstra, CEO, InterHealth Nutraceuticals, Benecia, CA. “It is important to educate consumers so they recognize that even if they do not have any form of diabetes, it is critical to manage blood sugar levels to help support a healthy weight and cardiovascular system.”
Natural Opportunities
Even healthy individuals who are aware of the diabetes epidemic are looking to take action through preventive measures, according to Mr. Meyrial. “When it comes to health and prevention, consumers are looking for natural solutions as alternatives to prescription medications,” he said. “Thus, functional foods and dietary supplements positioned to address issues of blood sugar management and issues of insulin resistance represent mass-market opportunities.”
Nutrition plays an important role in the management of blood glucose and associated complications in diabetes, he added. This is attributed to the ability of many food-based ingredients to modulate blood glucose without causing adverse health consequences.
Nutraceuticals can play a key role in helping consumers achieve their wellness goals, said Mr. Bornet. “Through well-balanced diet and continuous monitoring of blood sugar, consumers can complement their diabetes and blood sugar maintenance with nutraceuticals like Pycnogenol French maritime pine bark extract, which has been shown to dose-dependently lower sugar levels in type 2 diabetes patients. Studies have shown that nutraceuticals such as Pycnogenol can gradually lower fasting and post-prandial blood glucose levels, while not affecting insulin levels in type 2 diabetes patients.”
One of the greatest challenges with respect to diabetes is that more than half of individuals with the disorder are not clinically diagnosed, and so they aren’t under any form of medication to manage their elevated blood sugar levels, noted Shaheen Majeed, marketing director, Sabinsa Corporation, East Windsor, NJ. As a result, “It becomes very important to offer consumers nutraceuticals to support healthy blood sugar levels that have validated safety and efficacy.”
In the past, the prevalence of diabetes was largely restricted to those over the age of 40. However, lifestyle changes and other factors have made the disorder prevalent among young people as well.
“Juvenile diabetes and conditions like metabolic syndrome have led to a higher demand for nutraceuticals to support healthy blood sugar levels,” said Mr. Majeed. “Additionally, a close correlation has been observed between obesity and diabetes. With more individuals suffering from obesity, there has been a direct influence on the number of individuals with elevated blood sugar levels. An increase in demand for safe and effective products to manage this chronic disorder has thus seen an exponential increase.”
Overall, consumers are becoming more aware of the negative impact that high-glycemic foods can have on their bodies, and are differentiating between “good” and “bad” carbohydrates, according to Mr. Peters.
“Consumer research commissioned by BENEO shows that 53% of the U.S. population are concerned about healthy blood sugar levels and 55% about preventing diabetes (BENEO Fiber Research 2013). These results have been confirmed by insights from the International Food Information Council Foundation in 2014 saying that Americans are considering less sugar and/or high quality carbs as part of a healthy lifestyle in order to prevent a future health condition.”
Consumers still need more education when it comes to functional ingredients and dietary supplements, according to Mr. Dijkstra. “The industry also needs to do a better job at influencing diabetes educators and building awareness of how even a small lifestyle change such as supplementing with blood sugar health products can greatly impact lifelong health.”
Ingredients that have been clinically shown to benefit blood sugar and/or insulin levels can take advantage of a “blood sugar management” product positioning, he added. Manufacturers using these ingredients need to evaluate the science to see exactly how they can position products to consumers and what structure/function claims can be used in their marketing materials and on product labels.
Sweet Solutions
Product manufacturers are attempting to respond to the blood sugar struggle by delivering better product options. “The number of low glycemic product launches worldwide grew by 51% between 2013 and 2014 (Innova Market Insights),” said Mr. Peters. “In the U.S. one in five product launches carried a ‘low glycemic’ claim in 2014 (Mintel).”
To better understand the relevance of a low glycemic diet, it is important to know the role of insulin. Carbohydrates that provide energy in a more balanced way, resulting in a low blood glucose response, will also result in less insulin release and subsequently less severe metabolic changes, according to Mr. Peters.
“The hormone insulin plays a key role in the metabolic regulation after food intake; being released upon rising blood glucose levels, insulin promotes the uptake of nutrients from the blood into cells and their subsequent storage. Moreover, it promotes the predominant use of carbohydrates and suppresses the utilization of fat sources in energy metabolism. Whereas high insulin levels triggered by the consumption of medium-to-high glycemic carbohydrates are associated with a more extensive switch toward nutrient storage and suppression of fat utilization. Thus, consuming low glycemic carbohydrates, such as Palatinose, in place of high glycemic carbohydrates improves metabolic regulation.”
There are two basic options to minimize a food’s blood glucose response, according to Mr. Peters. The first is to modify the glucose supply in a way that the carbohydrate energy enters the body in a slow and sustained way by choosing, for example, low glycemic carbohydrates like the company’s Palatinose, which is classified as a sugar, but due to its molecular structure has unique physiological properties.
“It is low-glycemic yet fully digestible and thus seen as ‘good’ sugar,” said Mr. Peters. “Its uniqueness lies in the fact that it provides the body with the full amount of energy (4 kcal/g) in a balanced and sustained manner—reflected by a low and steady blood glucose response curve.”
Derived from the natural source beet sugar, it has a sugar-like sweet taste, is non-GMO and can be used in the development of a wide range of products.
The second strategy involves reducing the glucose supply by replacing fully available carbohydrates with prebiotic fibers such as oligofructose and inulin or sugar replacers (polyols) such as BENEO’s ISOMALT, which is also derived from beet sugar, he said.
Non-digestible, all-natural chicory fibers have a mild sweet taste and are soluble. Enrichment with dietary fibers, can help consumers maintain healthy blood sugar levels but also help in closing the so-called “fiber gap” while also improving digestive health.
Many consumers are looking to reduce sugar in their diets, particularly in their beverages, noted Scott Fabro, global business development manager for high intensity sweeteners at Cargill, Minneapolis, MN. “In addition, the recently announced new USDA My Plate Guidelines significantly affect the recommended amount of daily sugar consumption for Americans. Added sugars, in particular, are under fire. Cargill can help customers stay ahead of these guidelines and changing consumer preferences.”
For example, the company offers zero-calorie sweeteners ViaTech stevia sweetener and Zerose erythritol to help reformulate products that maintain consumer taste preferences while considerably reducing added sugars. “Even consumers managing health conditions look for great taste. With ViaTech stevia and Zerose erythritol, food and beverage manufacturers can make reduced/zero-calorie products that taste more like sugar-sweetened products.”
Creating the most sugar-like experience for consumers in reduced sugar applications is a major goal for new product developers. “Effective blending of sweetener ingredients can significantly improve the quality of sweetness, enhance sweet/sour balance and deliver a more robust flavor, which are all critical sensory characteristics for a successful product launch,” said Mr. Fabro.
In the past, stevia has been criticized for having a bitter, licorice-like aftertaste. However, Cargill’s proprietary taste-prediction model can predict which combination of steviol glycosides will deliver optimal taste and sweetness.
Combined with its unique technology, the company can help food and beverage manufacturers achieve optimal sweetness and significant sugar reduction in challenging reduced and zero calorie formulations, Mr. Fabro added.
Zerose erythritol, meanwhile, a natural, zero-calorie bulk sweetener is ideal for food and beverage applications promoting sugar reduction and weight management, and masks the aftertaste of intense sweeteners. It is also non-cariogenic, and has been clinically shown to offer “Better Tooth Protection” than other polyols, according to the company.
Fiber & Carb Control
When combined with healthy eating habits and exercise, nutraceuticals play an important role in helping consumers reduce the risk of type 2 diabetes and in helping people with diabetes or high blood sugar levels manage their conditions, said Ingredion’s Mr. Vega.
“Supplementation with nutraceuticals may help consumers by delivering or enhancing certain physiological benefits, such as increased insulin sensitivity, a key marker for type 2 diabetes, improved carbohydrate metabolism and reduction in the post prandial glycemic response of meals, among others.”
Ingredion’s HI-MAIZE resistant starch is a type of dietary fiber derived from a variety of corn that is high in amylose starch. This type of starch is resistant to digestion and acts like fiber in the human digestive tract. It is a white powder with a mild taste that can be incorporated into everyday foods like pasta, smoothies, bread, muffins and other baked goods, he said.
“More than 20 human clinical studies have shown the efficacy of high amylose corn resistant starch in reducing postprandial glycemic and/or insulinemic responses and/or second-meal effects,” said Mr. Vega. “Additionally, there are nine clinical studies showing improved insulin sensitivity, a key marker for type 2 diabetes, or improved responses to glucose tolerance tests. These are all important effects to help consumers maintain healthy blood sugar levels and overall good glycemic health.”
Ingredion has submitted a health claim petition to FDA for high-amylose corn resistant starch and reduction of risk for type 2 diabetes. The claim is currently under review.
Consumers are also increasingly associating blood sugar management with energy balance throughout the day, Mr. Vega added. “Whereas in the past, blood sugar management was perceived as purely a medical term, relevant only to those people diagnosed with type 2 diabetes, today’s consumers are learning that blood sugar levels impact their energy levels, their hunger and even their mood. Therefore consumers see it as increasingly important that they manage their blood sugar levels to lead healthy, active lives.”
According to research done by HealthFocus International in 2015, 54% of consumers say that tiredness or lack of energy is their main health concern. Additionally, nearly three in four consumers are interested in foods, beverages or nutraceuticals that could help them manage blood sugar levels, Mr. Vega said. “This growing consumer interest is resulting in an increasing number of requests and launches of products making these claims. This is especially the case for shakes, smoothies and bars sold through drug and other retail stores and through specialized channels.”
A recent study from Lund University in Sweden showed that barley can also help reduce blood sugar levels and the risk for diabetes. The secret lies in the special mixture of dietary fibers found in barley, which can also help reduce people’s appetite and risk for cardiovascular disease.
The study was conducted with healthy middle-aged participants who were asked to eat bread largely made out of barley kernels for three days—at breakfast, lunch and dinner. Approximately 11-14 hours after their final meal of the day participants were examined for risk indicators of diabetes and cardiovascular disease.
The researchers found that the participants’ metabolism improved for up to 14 hours, with additional benefits such as decreases in blood sugar and insulin levels, increases in insulin sensitivity and improved appetite control. The effects arise when the special mixture of dietary fibers in barley kernel reaches the gut, stimulating the increase of good bacteria and the release of important hormones.
In a previous, related study conducted with a team from the University of Gothenburg in Sweden, researchers also found that dietary fibers from barley kernel increase the gut bacteria Prevotella copri, which have a direct regulatory effect on blood sugar levels and help decrease the proportion of a type of gut bacteria that is considered unhealthy.
The effects from barley kernel are influenced by the composition of the individual’s gut microbiota, meaning people with low concentrations of the Prevotella copri bacteria experienced less effect from their intake of barley products. Eating more barley could, however, help stimulate growth of the bacteria.
Overall, messaging about effective steps to reduce blood glucose haven’t been clear, according to Dr. LaValle. “On one hand, the standard message given by healthcare organizations is to eat a balanced diet (reduced-fat diet) and to increase activity. Yet in truth, there are many studies showing that for insulin resistance-related risks and health problems, lower carbohydrate diets are much more effective.”
The Harvard School of Nutrition and Public Health, has been trying to educate consumers about the importance of at least lowering intake of refined sugars and sweeteners as well as high glycemic index foods like white flour, white rice and potatoes (starchy, low-fiber carbs), he added.
Despite all the evidence, and after 30 years experience in clinical practice, Dr. LaValle said people still don’t understand how to control their carbohydrate intake. “In my clinic, we use a method called carbohydrate counting, and it’s very effective. But there are other challenges. Even when someone knows what the right choices are they often can’t sustain lower carbohydrate diets for a variety of reasons. For example, people who are insulin resistant are inefficient in their energy production at the cellular level. With this inefficient energy production comes the need to ‘feed the machine’ with carbohydrates. In addition, things like stress and lack of sleep drive carbohydrate cravings. Unless people have access to good programs to address all these issues, they are going to be at risk, because their physiology is driving them to eat carbohydrates.”
A simple solution that Dr. LaValle has been recommending for many patients is Phase 2 Carb Controller, a proprietary extract of white kidney bean from Pharmachem Laboratories Inc., Kearny, NJ.
Phase 2 has been shown in approximately 18 human clinicals to support healthy weight loss as well as to support healthy blood sugar response, according to Mitch Skop, senior director of new product development at Pharmachem. “Our newest innovation is DietSpice,” he said. “DietSpice is formulated to help people lose weight and manage healthy blood sugar literally while they eat, in the form of delicious functional seasonings that are sprinkled atop or mixed into healthy meals. Because of its versatility, we think our manufacturing customers will readily see the marketing advantages of this new delivery system for Phase 2. It’s also a concept that is so easy for consumers to understand: use the tasty seasoning in their foods, and the seasonings will immediately start going to work. Plus, there is definitely a ‘yum’ factor, which of course is a priority for consumers.”
Most consumers who commit themselves to healthier eating are unwilling to sacrifice the satisfaction of eating tasty, substantive food, said Mr. Skop. “Whether it’s pasta, potatoes, rice, breads or cereals, DietSpice adds popular flavors—Italian, Asian, Butter & Spice and Cinnamon Sweetener—with the benefits of Phase 2.”
Herbal Reprieve
The increase of scientific evidence about the health effects of herbal preparations has led to a growing inclination toward natural herbs and botanicals as alternatives to pharmaceuticals, according to Frutarom’s Mr. Meyrial. However, safety, efficacy and consistent quality are essential to gain consumers’ trust and to ensure long-term success of the market.
Frutarom’s product Portusana (EFLA 308), a scientifically supported, highly concentrated purslane herb extract, supports blood glucose metabolism by acting on three key mechanisms, he noted. First, it significantly reduces intestinal glucose absorption in the Caco-2 cell line, suggesting a beneficial effect on the glycemic load of food for the body. Portusana also significantly and dose-dependently stimulates blood glucose uptake into the cells, both in the presence and absence of insulin. Third, it modulates the nuclear receptor PPARγ (peroxisome proliferator-activated receptor gamma), a receptor regulating glucose metabolism, among other things, resulting in increased insulin sensitivity and decreased blood glucose levels.
The company also offers FenuLife, a patented and clinically proven galactomannan fiber from fenugreek seeds. In the stomach, FenuLife absorbs moisture, forming a thick, viscous mass, which is the key to its unique health properties, said Mr. Meyrial. This increased viscosity and mass leads to slower gastric emptying and absorption of glucose.
Throughout the past decade, consumers have been doing more of their own research online, evaluating supplements and natural ingredients, especially branded ones that are backed by safety and efficacy data, noted Horphag’s Mr. Bornet.
Pycnogenol French maritime pine bark extract has gained credibility thanks to the amount of research confirming its safety and efficacy for a range of health conditions. “Horphag Research is very active in communicating with consumers by way of investing in consumer education campaigns to teach about the science behind Pycnogenol, its 40 years of research, 340 scientific publications including 135 clinical trials on more than 10,000 patients, and raise awareness of the brand,” said Mr. Bornet. “Interestingly, we have noticed a significant correlation between Pycnogenol sales growth and the number of new clinical studies. Undoubtedly, research has been, is and will most certainly remain a key factor which positively influences sales in an increasingly educated consumer market.”
Carolina Burki-Sozzi, director of product development at Horphag Research, noted there is an ample amount of research and clinical findings on the benefits of Pycnogenol as it applies to managing the effects of diabetes and blood sugar levels.
For example, a 2008 study published in the journal Nutrition Research showed Pyconogenol naturally reduced cardiovascular risk factors in diabetes patients, including lower blood sugar levels, LDL (low-density lipoprotein) cholesterol and blood pressure. A study published in Phytotherapy Research in 2013 also found Pycnogenol can help reduce metabolic syndrome risk factors, including waistline obesity, high cholesterol, high blood pressure and high blood sugar. Additionally, Pycnogenol has been found to naturally improve kidney function in patients with metabolic syndrome. This study, published in Panminerva Medica, found the antioxidant effective in controlling blood pressure, reducing blood sugar and lowering body mass index (BMI) due to weight loss.
Other notable botanical solutions include cinnamon, which has a long history of use as a spice and flavoring agent. “Several in vitro and in vivo studies have indicated that cinnamon may mimic insulin effects and thus may improve glucose utilization,” said Sabinsa’s Mr. Majeed. “In vitro studies have shown that cinnamon enhances glucose uptake by activating insulin receptor (IR) kinase activity, autophosphorylation of IR, glycogen synthesis and glycogen synthase activity.”
Sabinsa offers cinnamon extract from the bark of Cinnamomum cassia, which is standardized to contain 20% polyphenols.
In a study involving 79 people diagnosed with type 2 diabetes, subjects were randomly assigned to take cinnamon extract or placebo three times per day for four months. At the end of the study it was observed that the mean absolute and percentage differences between the pre- and post-intervention fasting plasma glucose level of the cinnamon and placebo groups were significantly different. Cinnamon extract was found to have a positive effect in reducing fasting plasma glucose concentrations in diabetic patients with poor glycemic control.
In another randomized study on 109 type 2 diabetics (HbA1C >7.0) across three primary care clinics at a U.S. military base, cinnamon extract was randomly assigned to participants for 90 days. Results showed that cinnamon lowered HbA1C by 0.83% compared with usual care alone lowering HbA1C (0.37%).
Sabinsa also offers Fenumannans, a standardized extract from the seeds of Fenugreek (Trigonella foenum-graecum) that contains a minimum of 60% galactomannan.
Numerous clinical studies have been carried out on the role of Fenugreek extract on blood sugar management, according to Mr. Majeed. In one particular study on 10 subjects, significant mean improvements in fasting blood glucose levels and glucose-tolerance test was observed. There was also a reduction in fasting blood glucose ranging from 157 mg/dl to 116 mg/dl (p<0.05). The 24-hour urinary glucose excretion was statistically significant in comparison with the control.
Other herbs Sabinsa markets for blood sugar control include Fabenol and Fabenol Max, standardized extracts of Phaseolus vulgaris (common kidney bean). Fabenol is a natural carbohydrate blocker. It is a natural extract with alpha-amylase inhibitory activity, according to the company.
In a pilot study, after-meal blood sugar levels were measured in a group of healthy subjects after taking 50 grams of carbohydrate in the form of wheat, rice and other high-carbohydrate plant foods. Phaseolus vulgaris inhibited the average post-ingestion spike in blood sugar by 67%.
Minerals (For The Mind)
Baby Boomers are the first generation that fully understands the implications of poor glucose metabolism, which leads to diabetes and its various co-morbidities, such as heart disease and even dementia, said Bill Levi, vice president, Strategy & Business Development, Nutrition 21, LLC, Purchase, NY.
“In particular, they have experienced firsthand the tremendous effects that cognitive decline has had on family members; and they are scared. Consumer surveys suggest that fear of cognitive decline is right up there with fears of cancer and heart disease. It is estimated that dementia affects 35 million people worldwide. The U.S. Centers for Disease Control and Prevention (CDC) estimates that Alzheimer’s disease currently affects some 5 million Americans. These numbers are expected to increase as the Baby Boomer generation ages. The New England Journal of Medicine article, ‘Glucose Levels and Risk of Dementia,’ has drawn national and local media attention; yet current dietary supplements that support brain health and cognition are not addressing healthy brain glucose metabolism.”
Proper cognitive function, such as memory, perception and cognition, require consistent healthy glucose metabolism in the brain. As a result, compromised metabolism of glucose can lead to a breakdown in cognitive function and have a harmful effect on overall brain health by significantly reducing brain glucose transporters, he added.
Nutrition 21 has invested in research and products that support this emerging understanding of the correlation between healthy glucose metabolism and a healthy brain. “Evidence supports the role of Chromax chromium picolinate in healthy glucose metabolism and in maintaining healthy blood glucose levels. Additionally, a number of studies have contributed to the understanding of Chromax chromium picolinate’s role in brain neurotransmission and have uncovered key insights into the beneficial role Chromax supplementation plays in the metabolic and biochemical pathways of the brain.”
Robert Krikorian, PhD, from the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati Academic Health Center, concluded his research has shown the benefits of metabolic intervention with Chromax chromium picolinate supplementation in supporting the improvement of age-related memory decline. This conclusion suggests that metabolic disturbances can be corrected with dietary modification and supplementation.
“Chromax chromium picolinate supports brain glucose transporter function and contributes to healthy glucose metabolism, significantly affecting a healthy mood and cognitive function,” commented James Komorowski, vice president, Scientific & Regulatory Affairs, at Nutrition 21.
InterHealth offers ChromeMate and Zychrome branded forms of chromium. ChromeMate, a unique, patented niacin-bound chromium complex that significantly increases the biological activity and efficacy of chromium, according to the company. Clinical research supports the use of ChromeMate niacin-bound chromium complex for blood sugar control, lipid modification and maintaining healthy body weight.
In a randomized, double-blind, placebo-controlled, 20-subject study, researchers from Georgetown University and Creighton University found that 3 mg of ChromeMate delivering 300 mcg of chromium a day for three months significantly lowered fasting blood sugar levels while placebo had no effect. ChromeMate decreased HbA1c levels—a biomarker for long-term glucose control.
Challenges Ahead
According to Ingredion’s Mr. Vega, the main challenges for product developers of nutraceuticals looking to make healthy blood sugar or glycemic health claims are: 1) finding ingredients that are safe and have credible science to support claims; and 2) the ability to include the minimum effective dosages in the traditional formats of nutraceuticals.
“There are many ingredients that claim to have benefits in the area of glycemic health, but either the science is not credible, it is not conducted in humans or is very limited,” he said. “Also, many ingredients being promoted have several potential side effects, such as digestive discomfort and laxation. It is important that formulators carefully evaluate ingredients for their safety and strength of clinical science.”
Regarding effective dose, in order to have a meaningful impact in reducing glucose response or affecting carbohydrate metabolism, many ingredients require larger inclusions per serving or dose. Product developers must consider all types of delivery formats, including bars and shakes, when formulating effective nutraceuticals for glycemic health. These formats align well with consumers, as they look for products that will help them stay fuller longer, balance their energy throughout the day and maintain healthy blood sugar levels.
Pharmachem’s Mr. Skops said the main challenges are not to overpromise and under-deliver. “When formulating, use the full dosage of the ingredient that has been shown in human clinicals to deliver the specific results. Also, due diligence must be performed to ensure that a multiple-ingredient formula will not have ingredients that war with one another, cancel each other out, or otherwise impede the original potency and efficacy of each other.”
Natural products manufacturers often face the problem of adulteration in the market, noted Sabinsa’s Mr. Majeed. “At any level, adulteration is a serious threat to consumers and the sustainability of the industry, so robust testing and supplier vetting is imperative.”
Diabetes is one of the largest global health emergencies of the 21st century, as noted by the International Diabetes Federation’s (IDF) “2015 Diabetes Atlas.” In addition to the 415 million adults who are estimated to currently have diabetes worldwide, there are 318 million adults with impaired glucose tolerance, which puts them at high risk of developing the disease in the future. By 2040, IDF estimated 642 million people around the world could have diabetes.
In the U.S., an estimated 29 million people have the disease, 8.1 million of whom may be undiagnosed and unaware of their condition. In terms of new cases, 1.4 million Americans are diagnosed every year. In 2012, 86 million Americans age 20 and older had pre-diabetes, up from 79 million in 2010.
People who have diabetes are at higher risk for serious health complications, including kidney failure, heart disease, stroke, blindness and peripheral neuropathy. Ultimately, risk of death for adults with diabetes is 50% higher than for those without the disease.
The economic impact on society is also sizeable. Total costs of diagnosed diabetes cases in the U.S. in 2012 were $245 billion ($176 billion for direct medical costs and $69 billion in reduced productivity), according to the American Diabetes Association.
Healthcare costs continue to increase, according to IDF, with 12% of global health expenditure dedicated to diabetes treatment and related complications that account for the majority of the total costs.
Cause & Effect
As reported in the recent 2015-2020 Dietary Guidelines for Americans (DGA), people are consuming higher amounts of calories and refined, processed foods than they should, said Santiago Vega, senior manager of nutrition marketing, Ingredion Incorporated, Bridgewater, NJ. “The DGA Expert Committee indicates that Americans are consuming roughly double the amount of sugar that is recommended to maintain a healthy diet. This is happening in combination with high consumption of foods that contain large amounts of fats, refined flours and other processed ingredients that contribute to increasing blood sugar levels and weight gain. Add to this a sedentary lifestyle and the problems become exacerbated.”
Many people simply don’t understand how high their risk is, according to James LaValle, clinical pharmacist, board-certified clinical nutritionist and author of Your Blood Never Lies.
“We’ve known for quite a number of years that as people start to have elevated blood glucose their risk of diabetes increases.” But a study published in 2008 found that for every point above blood glucose level of 85 mg/dL a person’s risk for developing diabetes increases 6%. This means by the time they reach a level of 94, their risk increases by more than 50%; by the time they reach 99, that risk has increased by nearly 100%.
“Why is this important? Because these are numbers that are technically still in the normal range, but it’s ‘high-normal’ and it means increased risk. People could be doing something, but they don’t even understand that they are at risk. If you don’t get that message and you don’t do something to intervene, the next step is called pre-diabetes, which is the 100-120 mg/dL blood glucose range. People who enter this level have what is called ‘impaired glucose tolerance,’ and 70% of the people in this range will go on to develop diabetes.”
Ultimately, modern diets are leading the public down a deadly road, as many consumers struggle with the long-term effects of their eating habits, noted Jon Peters, president, BENEO, Inc. Morris Plains, NJ. For example, too many diets consist of large amounts of high glycemic carbohydrates like glucose, sucrose and maltodextrin.
“The clinical manifestation resulting from an individual’s unsuitable diet only becomes noticeable after doing small things wrong for a long period of time,” said Mr. Peters. “Human blood glucose regulation is a sensitive system that might become imbalanced over time if challenged constantly by high glucose loads that need to be regulated.”
The challenge consumers face when maintaining blood sugar and diabetes is that blood sugar levels change—sometimes unexpectedly, noted Sébastien Bornet, vice president of global sales and marketing at Horphag Research (exclusive worldwide supplier of Pycnogenol), Hoboken, NJ. “In addition, food additives, such as sugar and carbohydrates are sneaking into food more and more, making it difficult for consumers to easily pinpoint foods with high levels of certain ingredients, like sugar and carbohydrates.”
Persistently elevated concentrations of glucose in the blood negatively affect the health of blood vessels, the heart and nerves, said Nicolas Meyrial, vice president of sales & business development of Frutarom Health BU for North America. “Even more alarming is the increasing incidence of children and adolescents with type 2 diabetes showing signs of complications.”
There’s a misconception among the general population that managing blood sugar is an isolated idea that only applies to people with diabetes, said Paul Dijkstra, CEO, InterHealth Nutraceuticals, Benecia, CA. “It is important to educate consumers so they recognize that even if they do not have any form of diabetes, it is critical to manage blood sugar levels to help support a healthy weight and cardiovascular system.”
Natural Opportunities
Even healthy individuals who are aware of the diabetes epidemic are looking to take action through preventive measures, according to Mr. Meyrial. “When it comes to health and prevention, consumers are looking for natural solutions as alternatives to prescription medications,” he said. “Thus, functional foods and dietary supplements positioned to address issues of blood sugar management and issues of insulin resistance represent mass-market opportunities.”
Nutrition plays an important role in the management of blood glucose and associated complications in diabetes, he added. This is attributed to the ability of many food-based ingredients to modulate blood glucose without causing adverse health consequences.
Nutraceuticals can play a key role in helping consumers achieve their wellness goals, said Mr. Bornet. “Through well-balanced diet and continuous monitoring of blood sugar, consumers can complement their diabetes and blood sugar maintenance with nutraceuticals like Pycnogenol French maritime pine bark extract, which has been shown to dose-dependently lower sugar levels in type 2 diabetes patients. Studies have shown that nutraceuticals such as Pycnogenol can gradually lower fasting and post-prandial blood glucose levels, while not affecting insulin levels in type 2 diabetes patients.”
One of the greatest challenges with respect to diabetes is that more than half of individuals with the disorder are not clinically diagnosed, and so they aren’t under any form of medication to manage their elevated blood sugar levels, noted Shaheen Majeed, marketing director, Sabinsa Corporation, East Windsor, NJ. As a result, “It becomes very important to offer consumers nutraceuticals to support healthy blood sugar levels that have validated safety and efficacy.”
In the past, the prevalence of diabetes was largely restricted to those over the age of 40. However, lifestyle changes and other factors have made the disorder prevalent among young people as well.
“Juvenile diabetes and conditions like metabolic syndrome have led to a higher demand for nutraceuticals to support healthy blood sugar levels,” said Mr. Majeed. “Additionally, a close correlation has been observed between obesity and diabetes. With more individuals suffering from obesity, there has been a direct influence on the number of individuals with elevated blood sugar levels. An increase in demand for safe and effective products to manage this chronic disorder has thus seen an exponential increase.”
Overall, consumers are becoming more aware of the negative impact that high-glycemic foods can have on their bodies, and are differentiating between “good” and “bad” carbohydrates, according to Mr. Peters.
“Consumer research commissioned by BENEO shows that 53% of the U.S. population are concerned about healthy blood sugar levels and 55% about preventing diabetes (BENEO Fiber Research 2013). These results have been confirmed by insights from the International Food Information Council Foundation in 2014 saying that Americans are considering less sugar and/or high quality carbs as part of a healthy lifestyle in order to prevent a future health condition.”
Consumers still need more education when it comes to functional ingredients and dietary supplements, according to Mr. Dijkstra. “The industry also needs to do a better job at influencing diabetes educators and building awareness of how even a small lifestyle change such as supplementing with blood sugar health products can greatly impact lifelong health.”
Ingredients that have been clinically shown to benefit blood sugar and/or insulin levels can take advantage of a “blood sugar management” product positioning, he added. Manufacturers using these ingredients need to evaluate the science to see exactly how they can position products to consumers and what structure/function claims can be used in their marketing materials and on product labels.
Sweet Solutions
Product manufacturers are attempting to respond to the blood sugar struggle by delivering better product options. “The number of low glycemic product launches worldwide grew by 51% between 2013 and 2014 (Innova Market Insights),” said Mr. Peters. “In the U.S. one in five product launches carried a ‘low glycemic’ claim in 2014 (Mintel).”
To better understand the relevance of a low glycemic diet, it is important to know the role of insulin. Carbohydrates that provide energy in a more balanced way, resulting in a low blood glucose response, will also result in less insulin release and subsequently less severe metabolic changes, according to Mr. Peters.
“The hormone insulin plays a key role in the metabolic regulation after food intake; being released upon rising blood glucose levels, insulin promotes the uptake of nutrients from the blood into cells and their subsequent storage. Moreover, it promotes the predominant use of carbohydrates and suppresses the utilization of fat sources in energy metabolism. Whereas high insulin levels triggered by the consumption of medium-to-high glycemic carbohydrates are associated with a more extensive switch toward nutrient storage and suppression of fat utilization. Thus, consuming low glycemic carbohydrates, such as Palatinose, in place of high glycemic carbohydrates improves metabolic regulation.”
There are two basic options to minimize a food’s blood glucose response, according to Mr. Peters. The first is to modify the glucose supply in a way that the carbohydrate energy enters the body in a slow and sustained way by choosing, for example, low glycemic carbohydrates like the company’s Palatinose, which is classified as a sugar, but due to its molecular structure has unique physiological properties.
“It is low-glycemic yet fully digestible and thus seen as ‘good’ sugar,” said Mr. Peters. “Its uniqueness lies in the fact that it provides the body with the full amount of energy (4 kcal/g) in a balanced and sustained manner—reflected by a low and steady blood glucose response curve.”
Derived from the natural source beet sugar, it has a sugar-like sweet taste, is non-GMO and can be used in the development of a wide range of products.
The second strategy involves reducing the glucose supply by replacing fully available carbohydrates with prebiotic fibers such as oligofructose and inulin or sugar replacers (polyols) such as BENEO’s ISOMALT, which is also derived from beet sugar, he said.
Non-digestible, all-natural chicory fibers have a mild sweet taste and are soluble. Enrichment with dietary fibers, can help consumers maintain healthy blood sugar levels but also help in closing the so-called “fiber gap” while also improving digestive health.
Many consumers are looking to reduce sugar in their diets, particularly in their beverages, noted Scott Fabro, global business development manager for high intensity sweeteners at Cargill, Minneapolis, MN. “In addition, the recently announced new USDA My Plate Guidelines significantly affect the recommended amount of daily sugar consumption for Americans. Added sugars, in particular, are under fire. Cargill can help customers stay ahead of these guidelines and changing consumer preferences.”
For example, the company offers zero-calorie sweeteners ViaTech stevia sweetener and Zerose erythritol to help reformulate products that maintain consumer taste preferences while considerably reducing added sugars. “Even consumers managing health conditions look for great taste. With ViaTech stevia and Zerose erythritol, food and beverage manufacturers can make reduced/zero-calorie products that taste more like sugar-sweetened products.”
Creating the most sugar-like experience for consumers in reduced sugar applications is a major goal for new product developers. “Effective blending of sweetener ingredients can significantly improve the quality of sweetness, enhance sweet/sour balance and deliver a more robust flavor, which are all critical sensory characteristics for a successful product launch,” said Mr. Fabro.
In the past, stevia has been criticized for having a bitter, licorice-like aftertaste. However, Cargill’s proprietary taste-prediction model can predict which combination of steviol glycosides will deliver optimal taste and sweetness.
Combined with its unique technology, the company can help food and beverage manufacturers achieve optimal sweetness and significant sugar reduction in challenging reduced and zero calorie formulations, Mr. Fabro added.
Zerose erythritol, meanwhile, a natural, zero-calorie bulk sweetener is ideal for food and beverage applications promoting sugar reduction and weight management, and masks the aftertaste of intense sweeteners. It is also non-cariogenic, and has been clinically shown to offer “Better Tooth Protection” than other polyols, according to the company.
Fiber & Carb Control
When combined with healthy eating habits and exercise, nutraceuticals play an important role in helping consumers reduce the risk of type 2 diabetes and in helping people with diabetes or high blood sugar levels manage their conditions, said Ingredion’s Mr. Vega.
“Supplementation with nutraceuticals may help consumers by delivering or enhancing certain physiological benefits, such as increased insulin sensitivity, a key marker for type 2 diabetes, improved carbohydrate metabolism and reduction in the post prandial glycemic response of meals, among others.”
Ingredion’s HI-MAIZE resistant starch is a type of dietary fiber derived from a variety of corn that is high in amylose starch. This type of starch is resistant to digestion and acts like fiber in the human digestive tract. It is a white powder with a mild taste that can be incorporated into everyday foods like pasta, smoothies, bread, muffins and other baked goods, he said.
“More than 20 human clinical studies have shown the efficacy of high amylose corn resistant starch in reducing postprandial glycemic and/or insulinemic responses and/or second-meal effects,” said Mr. Vega. “Additionally, there are nine clinical studies showing improved insulin sensitivity, a key marker for type 2 diabetes, or improved responses to glucose tolerance tests. These are all important effects to help consumers maintain healthy blood sugar levels and overall good glycemic health.”
Ingredion has submitted a health claim petition to FDA for high-amylose corn resistant starch and reduction of risk for type 2 diabetes. The claim is currently under review.
Consumers are also increasingly associating blood sugar management with energy balance throughout the day, Mr. Vega added. “Whereas in the past, blood sugar management was perceived as purely a medical term, relevant only to those people diagnosed with type 2 diabetes, today’s consumers are learning that blood sugar levels impact their energy levels, their hunger and even their mood. Therefore consumers see it as increasingly important that they manage their blood sugar levels to lead healthy, active lives.”
According to research done by HealthFocus International in 2015, 54% of consumers say that tiredness or lack of energy is their main health concern. Additionally, nearly three in four consumers are interested in foods, beverages or nutraceuticals that could help them manage blood sugar levels, Mr. Vega said. “This growing consumer interest is resulting in an increasing number of requests and launches of products making these claims. This is especially the case for shakes, smoothies and bars sold through drug and other retail stores and through specialized channels.”
A recent study from Lund University in Sweden showed that barley can also help reduce blood sugar levels and the risk for diabetes. The secret lies in the special mixture of dietary fibers found in barley, which can also help reduce people’s appetite and risk for cardiovascular disease.
The study was conducted with healthy middle-aged participants who were asked to eat bread largely made out of barley kernels for three days—at breakfast, lunch and dinner. Approximately 11-14 hours after their final meal of the day participants were examined for risk indicators of diabetes and cardiovascular disease.
The researchers found that the participants’ metabolism improved for up to 14 hours, with additional benefits such as decreases in blood sugar and insulin levels, increases in insulin sensitivity and improved appetite control. The effects arise when the special mixture of dietary fibers in barley kernel reaches the gut, stimulating the increase of good bacteria and the release of important hormones.
In a previous, related study conducted with a team from the University of Gothenburg in Sweden, researchers also found that dietary fibers from barley kernel increase the gut bacteria Prevotella copri, which have a direct regulatory effect on blood sugar levels and help decrease the proportion of a type of gut bacteria that is considered unhealthy.
The effects from barley kernel are influenced by the composition of the individual’s gut microbiota, meaning people with low concentrations of the Prevotella copri bacteria experienced less effect from their intake of barley products. Eating more barley could, however, help stimulate growth of the bacteria.
Overall, messaging about effective steps to reduce blood glucose haven’t been clear, according to Dr. LaValle. “On one hand, the standard message given by healthcare organizations is to eat a balanced diet (reduced-fat diet) and to increase activity. Yet in truth, there are many studies showing that for insulin resistance-related risks and health problems, lower carbohydrate diets are much more effective.”
The Harvard School of Nutrition and Public Health, has been trying to educate consumers about the importance of at least lowering intake of refined sugars and sweeteners as well as high glycemic index foods like white flour, white rice and potatoes (starchy, low-fiber carbs), he added.
Despite all the evidence, and after 30 years experience in clinical practice, Dr. LaValle said people still don’t understand how to control their carbohydrate intake. “In my clinic, we use a method called carbohydrate counting, and it’s very effective. But there are other challenges. Even when someone knows what the right choices are they often can’t sustain lower carbohydrate diets for a variety of reasons. For example, people who are insulin resistant are inefficient in their energy production at the cellular level. With this inefficient energy production comes the need to ‘feed the machine’ with carbohydrates. In addition, things like stress and lack of sleep drive carbohydrate cravings. Unless people have access to good programs to address all these issues, they are going to be at risk, because their physiology is driving them to eat carbohydrates.”
A simple solution that Dr. LaValle has been recommending for many patients is Phase 2 Carb Controller, a proprietary extract of white kidney bean from Pharmachem Laboratories Inc., Kearny, NJ.
Phase 2 has been shown in approximately 18 human clinicals to support healthy weight loss as well as to support healthy blood sugar response, according to Mitch Skop, senior director of new product development at Pharmachem. “Our newest innovation is DietSpice,” he said. “DietSpice is formulated to help people lose weight and manage healthy blood sugar literally while they eat, in the form of delicious functional seasonings that are sprinkled atop or mixed into healthy meals. Because of its versatility, we think our manufacturing customers will readily see the marketing advantages of this new delivery system for Phase 2. It’s also a concept that is so easy for consumers to understand: use the tasty seasoning in their foods, and the seasonings will immediately start going to work. Plus, there is definitely a ‘yum’ factor, which of course is a priority for consumers.”
Most consumers who commit themselves to healthier eating are unwilling to sacrifice the satisfaction of eating tasty, substantive food, said Mr. Skop. “Whether it’s pasta, potatoes, rice, breads or cereals, DietSpice adds popular flavors—Italian, Asian, Butter & Spice and Cinnamon Sweetener—with the benefits of Phase 2.”
Herbal Reprieve
The increase of scientific evidence about the health effects of herbal preparations has led to a growing inclination toward natural herbs and botanicals as alternatives to pharmaceuticals, according to Frutarom’s Mr. Meyrial. However, safety, efficacy and consistent quality are essential to gain consumers’ trust and to ensure long-term success of the market.
Frutarom’s product Portusana (EFLA 308), a scientifically supported, highly concentrated purslane herb extract, supports blood glucose metabolism by acting on three key mechanisms, he noted. First, it significantly reduces intestinal glucose absorption in the Caco-2 cell line, suggesting a beneficial effect on the glycemic load of food for the body. Portusana also significantly and dose-dependently stimulates blood glucose uptake into the cells, both in the presence and absence of insulin. Third, it modulates the nuclear receptor PPARγ (peroxisome proliferator-activated receptor gamma), a receptor regulating glucose metabolism, among other things, resulting in increased insulin sensitivity and decreased blood glucose levels.
The company also offers FenuLife, a patented and clinically proven galactomannan fiber from fenugreek seeds. In the stomach, FenuLife absorbs moisture, forming a thick, viscous mass, which is the key to its unique health properties, said Mr. Meyrial. This increased viscosity and mass leads to slower gastric emptying and absorption of glucose.
Throughout the past decade, consumers have been doing more of their own research online, evaluating supplements and natural ingredients, especially branded ones that are backed by safety and efficacy data, noted Horphag’s Mr. Bornet.
Pycnogenol French maritime pine bark extract has gained credibility thanks to the amount of research confirming its safety and efficacy for a range of health conditions. “Horphag Research is very active in communicating with consumers by way of investing in consumer education campaigns to teach about the science behind Pycnogenol, its 40 years of research, 340 scientific publications including 135 clinical trials on more than 10,000 patients, and raise awareness of the brand,” said Mr. Bornet. “Interestingly, we have noticed a significant correlation between Pycnogenol sales growth and the number of new clinical studies. Undoubtedly, research has been, is and will most certainly remain a key factor which positively influences sales in an increasingly educated consumer market.”
Carolina Burki-Sozzi, director of product development at Horphag Research, noted there is an ample amount of research and clinical findings on the benefits of Pycnogenol as it applies to managing the effects of diabetes and blood sugar levels.
For example, a 2008 study published in the journal Nutrition Research showed Pyconogenol naturally reduced cardiovascular risk factors in diabetes patients, including lower blood sugar levels, LDL (low-density lipoprotein) cholesterol and blood pressure. A study published in Phytotherapy Research in 2013 also found Pycnogenol can help reduce metabolic syndrome risk factors, including waistline obesity, high cholesterol, high blood pressure and high blood sugar. Additionally, Pycnogenol has been found to naturally improve kidney function in patients with metabolic syndrome. This study, published in Panminerva Medica, found the antioxidant effective in controlling blood pressure, reducing blood sugar and lowering body mass index (BMI) due to weight loss.
Other notable botanical solutions include cinnamon, which has a long history of use as a spice and flavoring agent. “Several in vitro and in vivo studies have indicated that cinnamon may mimic insulin effects and thus may improve glucose utilization,” said Sabinsa’s Mr. Majeed. “In vitro studies have shown that cinnamon enhances glucose uptake by activating insulin receptor (IR) kinase activity, autophosphorylation of IR, glycogen synthesis and glycogen synthase activity.”
Sabinsa offers cinnamon extract from the bark of Cinnamomum cassia, which is standardized to contain 20% polyphenols.
In a study involving 79 people diagnosed with type 2 diabetes, subjects were randomly assigned to take cinnamon extract or placebo three times per day for four months. At the end of the study it was observed that the mean absolute and percentage differences between the pre- and post-intervention fasting plasma glucose level of the cinnamon and placebo groups were significantly different. Cinnamon extract was found to have a positive effect in reducing fasting plasma glucose concentrations in diabetic patients with poor glycemic control.
In another randomized study on 109 type 2 diabetics (HbA1C >7.0) across three primary care clinics at a U.S. military base, cinnamon extract was randomly assigned to participants for 90 days. Results showed that cinnamon lowered HbA1C by 0.83% compared with usual care alone lowering HbA1C (0.37%).
Sabinsa also offers Fenumannans, a standardized extract from the seeds of Fenugreek (Trigonella foenum-graecum) that contains a minimum of 60% galactomannan.
Numerous clinical studies have been carried out on the role of Fenugreek extract on blood sugar management, according to Mr. Majeed. In one particular study on 10 subjects, significant mean improvements in fasting blood glucose levels and glucose-tolerance test was observed. There was also a reduction in fasting blood glucose ranging from 157 mg/dl to 116 mg/dl (p<0.05). The 24-hour urinary glucose excretion was statistically significant in comparison with the control.
Other herbs Sabinsa markets for blood sugar control include Fabenol and Fabenol Max, standardized extracts of Phaseolus vulgaris (common kidney bean). Fabenol is a natural carbohydrate blocker. It is a natural extract with alpha-amylase inhibitory activity, according to the company.
In a pilot study, after-meal blood sugar levels were measured in a group of healthy subjects after taking 50 grams of carbohydrate in the form of wheat, rice and other high-carbohydrate plant foods. Phaseolus vulgaris inhibited the average post-ingestion spike in blood sugar by 67%.
Minerals (For The Mind)
Baby Boomers are the first generation that fully understands the implications of poor glucose metabolism, which leads to diabetes and its various co-morbidities, such as heart disease and even dementia, said Bill Levi, vice president, Strategy & Business Development, Nutrition 21, LLC, Purchase, NY.
“In particular, they have experienced firsthand the tremendous effects that cognitive decline has had on family members; and they are scared. Consumer surveys suggest that fear of cognitive decline is right up there with fears of cancer and heart disease. It is estimated that dementia affects 35 million people worldwide. The U.S. Centers for Disease Control and Prevention (CDC) estimates that Alzheimer’s disease currently affects some 5 million Americans. These numbers are expected to increase as the Baby Boomer generation ages. The New England Journal of Medicine article, ‘Glucose Levels and Risk of Dementia,’ has drawn national and local media attention; yet current dietary supplements that support brain health and cognition are not addressing healthy brain glucose metabolism.”
Proper cognitive function, such as memory, perception and cognition, require consistent healthy glucose metabolism in the brain. As a result, compromised metabolism of glucose can lead to a breakdown in cognitive function and have a harmful effect on overall brain health by significantly reducing brain glucose transporters, he added.
Nutrition 21 has invested in research and products that support this emerging understanding of the correlation between healthy glucose metabolism and a healthy brain. “Evidence supports the role of Chromax chromium picolinate in healthy glucose metabolism and in maintaining healthy blood glucose levels. Additionally, a number of studies have contributed to the understanding of Chromax chromium picolinate’s role in brain neurotransmission and have uncovered key insights into the beneficial role Chromax supplementation plays in the metabolic and biochemical pathways of the brain.”
Robert Krikorian, PhD, from the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati Academic Health Center, concluded his research has shown the benefits of metabolic intervention with Chromax chromium picolinate supplementation in supporting the improvement of age-related memory decline. This conclusion suggests that metabolic disturbances can be corrected with dietary modification and supplementation.
“Chromax chromium picolinate supports brain glucose transporter function and contributes to healthy glucose metabolism, significantly affecting a healthy mood and cognitive function,” commented James Komorowski, vice president, Scientific & Regulatory Affairs, at Nutrition 21.
InterHealth offers ChromeMate and Zychrome branded forms of chromium. ChromeMate, a unique, patented niacin-bound chromium complex that significantly increases the biological activity and efficacy of chromium, according to the company. Clinical research supports the use of ChromeMate niacin-bound chromium complex for blood sugar control, lipid modification and maintaining healthy body weight.
In a randomized, double-blind, placebo-controlled, 20-subject study, researchers from Georgetown University and Creighton University found that 3 mg of ChromeMate delivering 300 mcg of chromium a day for three months significantly lowered fasting blood sugar levels while placebo had no effect. ChromeMate decreased HbA1c levels—a biomarker for long-term glucose control.
Challenges Ahead
According to Ingredion’s Mr. Vega, the main challenges for product developers of nutraceuticals looking to make healthy blood sugar or glycemic health claims are: 1) finding ingredients that are safe and have credible science to support claims; and 2) the ability to include the minimum effective dosages in the traditional formats of nutraceuticals.
“There are many ingredients that claim to have benefits in the area of glycemic health, but either the science is not credible, it is not conducted in humans or is very limited,” he said. “Also, many ingredients being promoted have several potential side effects, such as digestive discomfort and laxation. It is important that formulators carefully evaluate ingredients for their safety and strength of clinical science.”
Regarding effective dose, in order to have a meaningful impact in reducing glucose response or affecting carbohydrate metabolism, many ingredients require larger inclusions per serving or dose. Product developers must consider all types of delivery formats, including bars and shakes, when formulating effective nutraceuticals for glycemic health. These formats align well with consumers, as they look for products that will help them stay fuller longer, balance their energy throughout the day and maintain healthy blood sugar levels.
Pharmachem’s Mr. Skops said the main challenges are not to overpromise and under-deliver. “When formulating, use the full dosage of the ingredient that has been shown in human clinicals to deliver the specific results. Also, due diligence must be performed to ensure that a multiple-ingredient formula will not have ingredients that war with one another, cancel each other out, or otherwise impede the original potency and efficacy of each other.”
Natural products manufacturers often face the problem of adulteration in the market, noted Sabinsa’s Mr. Majeed. “At any level, adulteration is a serious threat to consumers and the sustainability of the industry, so robust testing and supplier vetting is imperative.”
