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The Lifelong Journey of Natural Heart Health

K2VITAL®
 
Albion Minerals®
Heart Health Heart Health

Ingredient suppliers address consumers who, over time, will embrace many natural products and ingredients in the pursuit of cardio-metabolic wellness.

The increasing cases of mortality rate due to cardiovascular diseases is raising the global demand for heart health products. According to the World Health Organization (WHO), 17.9 million people died from cardiovascular disease (CVD) in 2016, which accounts for 31 percent of all deaths worldwide. This makes CVD the world’s No. 1 killer. According to Market Research, the global heart health products market is estimated to grow more than 6.5 percent during 2016-2022. The U.S. is one of the major markets holding a major share.

Sanni Raju, PhD, CEO and chairman with New Jersey-based Natreon, Inc., said natural ingredients continue to grow in popularity in a variety of markets, including heart health. “As cardiovascular disease is a major cause of mortality worldwide and prescription medications have side effects, many customers are looking for dietary supplements that complement their prescription medicines, diet and lifestyle. Natural ingredients are no longer a feature in heart health products but a requirement. Consumers’ choices continue to trend toward natural, non-GMO [genetically modified organism] and vegan product options. As sourcing and regulatory requirements continue to be more restrictive, premium quality, non-GMO, organic natural ingredients standardized to key bioactive are becoming more difficult to achieve.

“A second observation of the heart health market is the consumers’ expectation for clinically studied ingredients,” Raju noted. “In order to be successful in the heart health market, these clinical studies must show benefits across a variety of health conditions including healthy subjects, those with type 2 diabetes or diagnosed with metabolic syndrome.”

“When it comes to cardio-metabolic wellness,” added Karin Hermoni, PhD and head of science and nutrition at New Jersey-based Lycored, “today’s consumers are seeking natural solutions to help support their wellness over time. The heart and metabolic health indication is saturated with different natural solutions aiming to benefit different aspects of cardio-metabolic wellness.

“Nowadays,” she continued, “industry and consumers alike are more inclined to embrace the notion that supporting cardio-metabolic wellness is a multi-factorial practice that requires a holistic approach. While designing such solutions, we need to take into account the many risk factors that impact this process. There is no one magic risk factor that holds the key to cardio-metabolic health, and it is a lifelong journey of embracing healthy choices and active lifestyle. Supplements are exactly as their name suggests—supplementing (not replacing) a healthy lifestyle, to help consumers meet their wellness goals.”

Mark Mueller, founder and chief technology officer with Wisconsin-based Botanic Innovations, agreed that driving the market for heart health are natural ingredients. “But more interestingly, natural oils have fast-growing consumer, regulatory, and scientific interest. Omega-3s from fish and plant sources, such as flax, chia, and berry seed oils, have been recognized for heart health support for decades. And the FDA [Food and Drug Administration] announced in November that it would allow producers of edible oils that contain at least 70 percent oleic acid (like high oleic sunflower seed oil) to make qualified health claims that their products contain cardiovascular benefits.

Botanic Innovations’ house brand, Immuno-Viva, promotes Core (a blend of organic black cumin and black raspberry seed oils). “Core is clinically demonstrated to support heart health, so we use it as a prototype to create blends featuring black cumin seed oil.”

Heart Health Ingredients

Formulators and consumers have a significant range of ingredients for heart health at their discretion.

Regarding natural oils, Mueller stated that a diversity of mixed botanical oils with a diversity of nutrient profiles is best. “Targeting fatty acid ratios—omega 3-5-6-9—and optimizing diverse antioxidant benefits (carotenoids, vitamin Es, phenols), black cumin seed oil is optimal when blended with other oils, such as cranberry, raspberry, flax and chia seed oil. We have a patent supporting synergistic antioxidant activity with black cumin seed oil when blended with other cold-pressed seed oils. This phenomena is real. And why use one ingredient when combining them gives better benefits?”

Many of the Botanic Innovations fruit, vegetable and seed oil portfolio are appropriate for inclusion in heart support formulas. “We have human clinical data for organic black cumin seed oil blends, so we start there,” Mueller said. “We have made these ingredients for almost 20 years, and since 2009, have pressed more than 175,000 pounds of organic black cumin seeds. Berry seed oils are excellent to feature in heart support blends with black cumin seed oil, as would be tomato, chia or other novel oils.”

Headquartered in France, Naturex has developed a blood flow and cardiovascular platform based on the emerging superfruit aronia. Dan Souza, vice president of sales and marketing, said, “We’ve recently completed a randomized double-blinded placebo controlled human clinical trial in which we demonstrate significant improvements in blood flow (endothelial function) after chronic consumption of our full spectrum aronia powder and significant improvement in blood flow after both acute and chronic consumption of Aronox, our polyphenol-rich aronia extract. These data support our previously published studies on Aronox demonstrating improvement in blood pressure, cholesterol and triglycerides. Also, in our recent study, strong correlations were shown between aronia consumption, aronia polyphenol metabolites in plasma and improvement in endothelial function.”

Lycored’s journey in supporting cardiovascular wellness began with the flagship proprietary tomato extract Lycomato, which contains a synergistic blend of tomato phytonutrients that work together to provide cardiovascular benefits. Within the last few years, Lycored has launched its second-generation solution, which is a cardio-optimized and strictly standardized tomato Nutrient Complex called Cardiomato. Inspired by the vast benefits lycopene—the red carotenoid giving tomato its bright color and the synergy with other tomato phytonutrients such as vitamin E which contributes the protection of cells from oxidative—Cardiomato was formulated to foster improved cardio-metabolic wellness over time. This proprietary patented composition is standardized to preserve and enhance the natural efficacy of tomato nutrients utilizing the patented ratio with natural phytosterols that work together synergistically to deliver a wealth of benefits.

Chris Speed, Norway-based NattoPharma’s (with a North American subsidiary in New Jersey) senior vice president of global sales and marketing, noted that vitamin K2 as MK-7 is starting to earn recognition as an essential nutrient for cardiovascular health, as it is the only known compound to impact hardening of the arteries (i.e., atherosclerosis) caused by plaque building up inside the arteries.

“Over time, plaque (primarily made up of calcium) hardens and narrows the arteries. This limits the flow of oxygen-rich blood to your organs and other parts of the body, such as the heart, brain, arms, legs and kidneys,” Speed explained. As a result, he noted, different diseases may develop based on which arteries are affected:

• Coronary heart disease (CHD), also called coronary artery disease, occurs when plaque builds up in the coronary arteries

• Carotid artery disease occurs when plaque builds up in the arteries on each side of your neck (the carotid arteries)

• Peripheral artery disease (PAD) occurs if plaque builds up in the major arteries that supply blood to the arms, legs and pelvis

• Chronic kidney disease (CKD) can occur if plaque builds up in the renal arteries

This calcification was once thought to be an age-related condition—that calcification simply builds up over time.

A nutritional scientist and dietician, Speed added that, in fact, NattoPharma contends that this condition is not simply age-related; rather, atherosclerosis is the product of a vitamin deficiency: vitamin K2.

Matrix Gla Protein (MGP) is the most potent known inhibitor of vascular calcification to date, he said. MGP is a K-dependent protein already present in the body, but it needs adequate vitamin K2 in order to be activated to perform its function.

It is also worth noting that K2 works synergistically with other nutrients that are already used in cardiovascular health products:

• Vitamin D3. Both bone and cardiovascular health are dictated by how the body utilizes calcium. Ideally the body will bind calcium to the bone mineral matrix, making stronger, denser bones. But if left unattended, calcium does not make it to our bones. Rather, it will deposit in arteries, blood vessels, and soft tissues, increasing risks for developing cardiovascular diseases. Vitamin D3 synthesizes the proteins that help the body utilize calcium (i.e., osteocalcin for bone, MGP for heart), while vitamin K2 activates those proteins so they perform their respective functions.

• Omega-3 is widely recognized as a cardio-supportive nutrient, earning a qualified health claim for the reduction in risk of CHD in the U.S., and 4 EFSA (European Food Safety Authority) claims for cardiovascular health. While omega-3’s mechanism of action is linked to supporting healthy inflammation, triglycerides, blood pressure and promotion of arterial health, it is not recognized for impacting vascular calcification, which is what makes vitamin K2 a perfect complement.

Focusing on omega-3s, Norway-based Aker BioMarine, a biotech innovator and Antarctic krill-harvesting company, has been producing ingredients for essential fatty acids (EFAs) for 12 years. Aker BioMarine’s flagship product, Superba Krill, has come a long way over the past decade and has opened the doors to many new opportunities for the company and industry alike, including Superba 2 and Superba Boost, noted Katrin Berntsen, director of communication with the company.

In addition, at Wacker Biosolutions, Wacker Chemie AG, Munich, Germany, Rachela Mohr, manager of business development nutraceuticals, said the company offers two different food supplement types, which influence the heart health of customers: the nature-identical hydroxytyrosol HTEssence and CAVAQ10, a CoQ10 gamma-cyclodextrin inclusion complex.

Mohr explained that the nature-identical hydroxytyrosol HTEssence is able to significantly reduce LDL (low density lipoprotein) and in turn lower the risk of coronary heart disease. According to a study, a significant LDL-cholesterol reduction was seen after intervention with the pure, synthetic hydroxytyrosol in comparison to placebo (Siefer et al., 2018, Nutritional Medicine and Diet Care). Due to its diverse modes of action, hydroxytyrosol is a popular ingredient in dietary supplements.

Wacker’s patented process makes it possible to synthesize a nature-identical substance of much greater purity, free of unwanted by-products and with a defined amount of active ingredient. Available as an odorless, water-soluble powder and liquid, HTEssence is suitable for use in functional foods and dietary supplements, such as tablets, capsules, energy bars and functional beverages.

Studies also indicate a beneficial effect of CoQ10 on heart health through different mechanisms. It assists in maintaining the normal oxidative state of LDL cholesterol, helps assure circulatory health and supports optimal functioning of the heart muscle. Research has shown that CoQ10 levels are lower in patients with heart failure. Moreover, CoQ10 biosynthesis decreases with age and its deficit in tissues is associated with degenerative changes appearing in the course of aging. However, many products on the market cannot ensure adequate bioavailability, since CoQ10 is a fat-soluble substance, which is poorly absorbed. This problem has been solved with CAVAQ10: CAVAMAX, the natural cyclodextrins from Wacker which permits the molecular encapsulation of substances. With the help of gamma-cyclodextrin, the bioavailability of CoQ10 can be increased significantly, by a factor of 18 compared to a conventional CoQ10 product.

Also addressing absorption of an ingredient, OmniActive offers a unique curcumin to the marketplace. Because of curcumin’s inherent bioavailability challenges, the company developed its UltraSOL technology to increase its absorption, said Brian Appell, marketing manager with OmniActive Health Technologies in New Jersey. UltraSOL is a molecular dispersion process that converts lipophilic nutrients into water-dispersible ingredients to enhance bioavailability and retention greater than standard curcumin powder and other enhanced curcumin products. The results of a study the company conducted showed that CurcuWIN has 46 times higher relative absorption than standard curcumin (Jager R, et al. 2014).

CurcuWIN is a potential strategy for the early prevention of CVD and its associated costs. In a study using flow mediated dilation to assess endothelial function, CurcuWIN can significantly increase FMD (flow mediated dilation) in healthy subjects that may potentially reduce CVD risk by as much as 50 percent. CurcuWIN’s high bioavailability and long-lasting action play a vital role in its demonstrated benefits at a low dosage and provides greater formula flexibility and consumer compliance for those looking to formulate effective curcumin formulas (Oliver J, et al. 2016).

Evolution of Ingredients

A study of a specific ingredient disputed a long-held assumption. Natreon noted that amla extract has been a very popular ayurvedic product for centuries, and the belief was that it is very rich in vitamin C, said Raju. He said that Natreon has shown that amla fruit has very little vitamin C, but it has more powerful antioxidants. The company has done clinical studies in heart health and found that its patented Capros amla extract has excellent endothelial function and lipid profile enhancement properties along with platelet aggregation inhibition activity. It also reduced HbA1c by half a point in T2DM subjects. An ischemia-reperfusion injury animal study at University of Connecticut has shown that Capros significantly mitigated the heart muscle injury caused by ischemia reperfusion. “That is how Capros evolved as a heart health product,” Raju said.

Anne Trias, product director with Massachusetts-based American River Nutrition, a manufacturer of annatto-derived tocotrienols (patented and trademarked as DeltaGold), which are naturally tocopherol-free, said the company’s expertise in tocotrienols dates back to the 1990s. That’s when Dr. Barrie Tan was the first to commercially extract the ingredient from palm oil through its extraction from rice bran oil, and finally the discovery of annatto as a most unique source of 100 percent tocotrienols. “In that sense, DeltaGold annatto tocotrienol is the newest and most innovative vitamin E product currently on the market,” Trias said.

“As we work with our brand partners to introduce novel education avenues of vitamin E—the old and the new—consumers are beginning to take note of the superior benefits tocotrienols have to offer,” Trias explained. “Alpha-tocopherol is no longer the universal and only vitamin E choice to consider. Vitamin E in the form of alpha-tocopherol may shore up to be an ‘antioxidant, and nothing more,’ as one researcher and vitamin E expert of the Linus Pauling Institute at Oregon State University succinctly put it.

“Unquestionably, vitamin E is the most prevalent and important antioxidant in the lipid cell membrane, and is uniquely shaped to reside within the bilayer to protect its integrity. Of the vitamin E forms, tocotrienol simply does a better job, being ~50-fold as potent as an antioxidant compared to tocopherol. More importantly, tocotrienol provides benefits that are not shared by tocopherol, such as its hypocholesterolemic and significant anti-inflammatory properties. A recent clinical study also highlighted tocotrienol’s benefits in reducing cardiometabolic symptoms, improving Fatty Liver Index, and lowering triglycerides, body weight, and inflammatory markers.”

She added, “One critical element is to consistently recommend tocotrienol supplementation apart from alpha-tocopherol, as combining the two was repeatedly shown to interfere with tocotrienol functions and benefits.”

Also addressing tocotrienol, ExcelVite’s science-based ingredient for heart health is the EVNol SupraBio. “It is a patented and bio-enhanced natural full-spectrum palm tocotrienol complex that ensures an up to 300 percent increase in absorption for each tocotrienol isoform,” according to Bryan See, business development manager with ExcelVite in Malaysia. “It is the only tocotrienol complex in the market that is clinically proven and substantiated with both bioavailability (absorption into plasma) and bioefficiency (accumulation in vital human organs) studies. As such, EVNol SupraBio is the second generation of tocotrienol formulation with for assured bioavailability and bioefficiency. EVNol SupraBio is in a liquid form, which can be directly encapsulated into a soft gel or liquid capsule dosage form.

“EVNolMax, on the other hand,” See added, “is an enhanced delivery tocotrienol complex in powder form for manufacturers who want to develop tablets or functional food or drinks to deliver heart health benefits to consumers through a more variety of formats.”

At Botanic Innovations, Mueller noted that botanical oils are generally consistent with their component nutrients. “They have always supported heart health and other wellness benefits, but we are seeing an evolution with growing awareness and acceptance of the wonderful benefits of botanical oils. Key supplement formulators are maximizing heart and wellness benefits by developing high performance blends of botanical oils. One oil could do a good job supporting heart health, but why wouldn’t we blend the oils for optimal support?”

Proven by Science

As for the science of interest to formulators, Mueller said, “Safety first. Formulators of dietary supplements only work with ingredients that are proven safe and proven unadulterated with key labs and appropriate protocols. The scientific want list is extensive and we’re working hard to ensure that our partners get what they need. Botanic Innovations has multiple patents—featuring black cumin blends—and our partners use these as a springboard to develop safe and effective products.”

“As we are experiencing an increase in consumer awareness and demand for transparency, the industry is shaping to be more clinically responsible,” said Hermoni. “Consumers are less interested to see animal studies. Although still not yet the standard, we see more companies gravitating toward full scale, well-designed double blind placebo controlled studies. We also see a lot of focus on bioavailability research. Consumers and industry alike want to make sure that what we put in the supplement is in-fact well-absorbed in the body.”

Ingredient suppliers also noted other areas of interest. Souza noted, “improvements in blood flow as demonstrated by our Aronia Full Spectrum and Aronox powders allow our customers to not only position Aronia in the nearly $3 billion U.S. dietary supplement market, but also into applications where improved blood flow can have a positive impact such as the growing sports nutrition, cognition and skin/beauty from within market. Cost effectively delivering significant improvements in endothelial function is a foundational mechanism for cardiovascular health. Endothelial dysfunction may be considered relevant for classifying subjects in terms of CVD risk. In fact, recent meta-analysis has shown that a 1 percent improvement in endothelial function correlates to a 8 to 12 percent reduction in risk of CVD.”

Speed noted that manufacturers are interested in research and trials that will make an impact down at the store level. “Namely, that there is research supporting an ingredient’s safety and efficacy, and that that research is the basis for approved structure-function claims that can gain attention on the shelf. When it comes to Vitamin K2, MenaQ7 is the only K2 as MK-7 that can offer that sort of support.”

Raju noted the pragmatic aspects. “The scientific research helpful to manufacturers focus on the chemistry of the ingredient: is it soluble in water? Does it contribute to color, taste, odor? Is it in powder, liquid, semi-solid? The information needed to help manufacturers work with an ingredient more efficiently is not necessarily the same scientific research suppliers and consumers require. The best research available on an ingredient will substantiate a scientifically proven, attractive and marketable claim. To achieve such a claim, a supplier must invest in randomized, double-blind, placebo-controlled trials showing positive outcomes that will then substantiate marketing claims.”

Appell added, “Since heart health is, primarily a category built on prevention, assessing the benefits of nutraceuticals will depend on indices correlated to healthy cardiovascular function. These may include measuring the impact on cholesterol and/or blood sugar levels and other physiological functions, like flow mediated dilation (FMD)—what we focused on in our FloMeD study. I believe that direct measures, like FMD will continue to become a prominent indicator for long-term heart health.”

News and Trends

While some ingredients remain the same, a new test and a delivery method are moving the category in new directions.

“It’s important to point out that low omega-3 levels are associated with a multitude of health issues including heart disease,” Berntsen said. “And while we understand that omega-3s are essential for our health, we can’t ‘feel’ a low omega-3 level, just as we can’t feel a high cholesterol level or high blood sugar level or even high blood pressure. But like cholesterol and glucose, omega-3 levels can be measured in a blood test called the Omega-3 Index. The Omega-3 Index ranges from about 3 percent to 12 percent (or more) and those with higher levels are at a lower rate for heart disease. Some experts even consider the Omega-3 Index Test the ‘new cholesterol test.’”

Michelle Paule, director of sales with Botanic Innovations also pointed out that leading encapsulating companies who have emerging capsule technologies are changing the landscape in this category. “They create deliveries to promote products that consumers prefer like dual capsules to deliver oils and powders in one capsule, or capsules that time release the contents for better bioavailability. Our botanicals haven’t changed, but creative delivery systems and manufacturers are upping the game and helping our ingredients better impact users.”

Natreon’s Raju predicted that new products like urolithins will be the future heart health products. “Any new natural anti-diabetic products would also add to the arsenal of heart health products,” he said.

And, according to Appell, “Look to see more of heart health evolving in the sports nutrition market.” He explained, “More than any other system, a properly functioning cardiovascular system is critical for performance and recovery by supporting oxygen and nutrient availability, and uptake into working muscle cells and efficient removal of metabolic waste produced during exercise (eg lactic acid). It is a big reason why we did our FloMeD study with CurcuWIN, and we’re happy to see it had such a big impact on vasodilation, which is important during performance.” NIE

For More Information:

Aker BioMarine, www.akerbiomarine.com
American River Nutrition, www.americanrivernutrition.com
Botanic Innovations, www.botanicinnovations.com
ExcelVite, www.excelvite.com
Lycored, www.lycored.com
Natreon, www.natreoninc.com
NattoPharma, www.nattopharma.com
Naturex, www.naturex.com
OmniActive Health Technologies, www.omniactives.com
Wacker Biosolutions, www.wacker.com

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K2VITAL®
 
Albion Minerals®