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Investing in Heart Health

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Heart Health Heart Health

The heart health category is poised for substantial growth—that is if the dynamic market, growing segments and industry prognosticators have any say.

Cardiovascular disease, also called heart disease, encompasses a range of conditions that affect your heart, and include: blood vessel diseases, such as coronary artery disease; heart rhythm problems (arrhythmias); and heart defects we’re born with (congenital heart defects).

Cardiovascular disease typically refers to conditions that involve narrowed or blocked blood vessels that can lead to a heart attack, chest pain (angina) or stroke. Other heart conditions, such as those which affect the heart’s muscle, valves or rhythm, are also considered forms of heart disease. It is known that many forms of heart disease can be avoided with healthy lifestyle choices.

Globally, there are 17.3 million deaths a year linked to cardiovascular disease, according to the World Health Organization. In the U.S., about 610,000 people die of heart disease every year, with coronary heart disease (CHD) the most common type, taking the lives of over 370,000 people annually. According to the Centers for Disease Control and Prevention (CDC), at least 200,000 deaths from heart disease and stroke each year can be prevented if Americans adopted healthier habits relating to high blood pressure, diabetes, tobacco use, physical inactivity, obesity and unhealthy diets.

For consumers who wish to adopt a heart-healthier diet, a critical part of that approach should include thoughtful dietary supplementation with high-quality, research-backed products.

The Market

For consumers to find reputable, high-quality products, however, is becoming more of a challenge as the cardiovascular health category becomes more crowded.

“The heart health market is saturated with common heart health products, such as fish oil omega-3s, coenzyme Q10 (CoQ10), garlic, red yeast rice extracts, phytosterols—there is a lack of product differentiation,” noted Bryan See, regional product manager of New Jersey-based ingredient supplier, ExcelVite.

Karen E. Todd, RD, senior director of global brand marketing for New York-based ingredient maker Kyowa Hakko USA, agreed, adding that “The largest challenge in the heart-health category is the number of competitors.”

A common observation among experts NIE contacted for this article is that manufacturers and marketers hands are largely tied by the regulatory strictures placed on them with structure-function claim language and other labeling requirements.

“Our industry is limited in what can be written on a label—if a marketer or manufacturer has a heart health product, the only thing that they can write on the label is that the product supports heart health,” said Deanne Dolnick, science director for Georgia-based TR Nutritionals, an ingredient supplier. “Sterols, for example, have been approved for a cholesterol-lowering claim and, to my knowledge, there are no other ingredients where this claim can be made.” Dolnick noted that this makes it very difficult for consumers.

Aparna Kalidindi, PharmD, sales and marketing manager for New Jersey-based ingredient supplier Natreon, agreed, noting that the primary market challenge for any condition-specific ingredient or product are the limitations on what you can say about it in order to properly market it to the consumer. Consumer confusion at retail is a problem shared by many in the industry.

“If a consumer walks into a store and they are looking for a product to help them lower cholesterol, they’re not going to find what they’re looking for by reading the labels—if they have done their homework and they know that research has been conducted on many products where excellent results have been achieved, then they do not have to be concerned about the label,” Dolnick added. “They just need to find a brand that they trust.”

Regulatory restrictions on inflammation-related claims are a market challenge identified by industry stakeholders as especially problematic since inflammation is the underlying cause of many heart conditions.

“In a marketing sense, the challenge is that the market is crowded with heart health products that have different modes of action, which can be complex for the consumer to understand,” observed Dan Lifton, president of New York-based Maypro’s Proprietary Branded Ingredients Group.

“It is also challenging that many consumers do not start to proactively think about heart-health supplements until they’ve been diagnosed with high blood pressure or high cholesterol, in which case many physicians introduce them to pharmaceutical drugs immediately.”

The challenge, added Lifton, is to catch “borderline” consumers who are not ready to use prescription drugs for treatment and for whom we need to focus on promoting heart health in order to fend off potential problems.

Andrew Shea, director of marketing for Texas-based ingredient company, Kaneka Nutrients, sees the challenge at the nexus of regulatory scrutiny, supply chain integrity and quality.

“Supplement companies are doing business in a marketplace that is subject to increasing scrutiny by regulators and policymakers—at the same time, consumers are increasingly asking questions about where raw material is sourced and how it is manufactured,” observed Shea. “Quality, safety and efficacy have never been more important.”

Taking a page out of Deanne Dolnick’s playbook, Shea added that, “It takes a considerable amount of time and money to build a trusted brand, but just one problem in your supply chain can immediately destroy all that brand value.”

The Segments

Fruits and Super Fruits

We’ve heard a lot of buzz about super fruits over the last few years, much of it deserved, in terms of the range of benefits, including cardiovascular, that fruits and super fruits convey, including acai, goji and pomegranate, although there are others which also come with some serious research creds.

Bergamot (Citrus bergamia Risso et Poiteau) is a citrus plant that grows almost exclusively in the narrow coastal region of Calabria in southern Italy. Bergamot juice was traditionally recognized by the local population as a remedy for supporting what we would today call heart health.

Annie Eng, chief executive officer of Bradenton, Florida-based ingredient supplier, HP Ingredients, shared with NIE details on patented bergamot extract, Bergamonte.

Bergamonte contains bioactive compounds of extract of the juice and albedo of Citrus bergamia Risso standardized to over 30 percent polyphenolic flavonoids consisting of naringin, neohesperidin, neoeriocitrin, 1 percent melitidine, and 2 percent brutelidine. According to Eng, these flavonoids are clinically proven to help maintain healthy cholesterol levels, healthy blood glucose levels, and increase HDL-cholesterol.

Bergamonte’s mechanism of action is threefold, noted Eng. It inhibits HMG-CoA reductase, inhibits phosphodiesterases PDEs, and activates AMPK (5′ adenosine monophosphate-activated protein kinase).

In a study from 2011 in the journal Fitoterapia, 237 patients with hyperlipidemia, hypercholesterolemia, mixed dyslipidemia, or metabolic syndrome took either a placebo or Bergamonte in 500 mg or 1,000 mg doses per day for one month. By the end of the study, total cholesterol in the 500 mg Bergamonte group was lowered by 20.69 percent and by 26.53 percent in the 1,000 mg group, compared to an increase of 0.14 percent in the placebo group. High-density lipoprotein (HDL or “good” cholesterol) was beneficially boosted by nearly 30 percent in the 500 mg Bergamonte group and by 40 percent in the 1,000 mg group, while only by 1.2 percent in the placebo group. Low-density lipoprotein (LDL or “bad” cholesterol) was decreased by 24 percent in the 500 mg Bergamonte group and by 36 percent in the 1,000 mg group, and only 1.1 percent in the placebo group. Triglycerides decreased in the 500 mg Bergamonte group by 30 percent and by 38.8 percent in the 1,000 mg group compared to an increase of 0.1 percent in the placebo group.

Other research showed similar results, including an unpublished human clinical trial that involved 192 individuals who consumed 100 mg of Bergamonte for 30 days. The participants’ total cholesterol was reduced by 35.72 percent, their HDL improved by 56.05 percent, their LDL decreased by 41.95 percent and their triglycerides were lowered by 38.31 percent at the study’s end.

HP Ingredients also offers Maqui Superberry, which is described by Eng as the highest known antioxidant super fruit, containing high concentration of polyphenols and anthocyanins. “Our Maqui Superberry is wild-harvested by the Mapuche Indians in a certified organic native forest in Chile,” said Eng.

Maqui Superberry is said to assist in promoting heart health through fighting unhealthy inflammation and inhibiting copper-induced LDL oxidation, and is back by published research, including a study from 2011 which showed that maqui berry juice is strongly anti-inflammatory against nuclear factor kappa-B (NFκB), and also reduces COX-2 expression, an enzyme involved in inflammation.

“Although the FDA prohibits marketing directly to disease states, it is important that research continues to reveal how an herb or vitamin can affect, in this case, cardiovascular status in those consumers who may have a need for additional support for healthier systemic functioning,” added Eng.

Red palm fruit is another example of a fruit that packs a cardio and innovation punch.

New Jersey-based ingredient supplier, ExcelVite, has developed a portfolio of products that contain naturally occurring mixtures of tocotrienols and tocopherols extracted from red palm fruit.

According to ExcelVite’s Regional Product Manager Bryan See, “Specifically in the areas of cholesterol health, brain health and liver health, full spectrum palm tocotrienol complex, but not single form (d-alpha) tocopherol, demonstrated beneficial effects.”

He pointed to research that compared EVNol SupraBio with alpha-tocopherol. Participants who received 500 mg daily of EVNol SupraBio for four weeks had significantly lower total cholesterol and LDL-cholesterol levels compared to baseline (Ajuluchukwu JN, et al.).

Interestingly, EVNol naturally contains plant squalene, phytosterols, mixed carotenoids and CoQ10–that are naturally extracted together with the tocotrienols and tocopherols in a unique, full-spectrum process.

“Our validated process is an advanced multi-stage molecular distillation extraction process that operates in a range of operation parameters in order to ensure that the natural palm phytonutrient profile is being maintained in our products,” added See. “This extraction process employs high pressure and low temperature, and it allows ExcelVite to extract a natural full-spectrum palm tocotrienol complex (EVNol), a mixed carotene complex (EVTene), and a phytosterol complex (EVRol).”

“Unlike other tocotrienol producers, we produce our full-spectrum tocotrienol complex from virgin crude palm oil via molecular distillation,” noted See. “ We specify the minimum and maximum level of individual tocotrienol isoform (alpha, beta, gamma and delta), as well as minimum and maximum level of alpha-tocopherol in our product specifications.”

EVNol SupraBio has a patented self-emulsifying delivery system, one specifically developed to provide consistent and enhanced oral absorption of each individual tocotrienol isoform. The SupraBio system is formulated with a mixture of oil and food emulsifiers at what is said to be an optimum ratio and, through a homogenization process, self-emulsifies in the gastrointestinal tract, facilitating absorption. “This novel delivery system results in a rapid and consistent absorption of tocotrienols independent of dietary fat or food intake,” added See.

Our next entry in the cardio-friendly fruit segment is Phyllanthus emblica.

According to Natreon’s Aparna Kalidindi, Capros “is a super antioxidant and an excellent cardiovascular product, one which is all natural and derived from the edible fruits of P. emblica.”

It is manufactured by spray drying the juice extracted from freshly harvested fruits that have been washed in purified water. “Maximum yield of the bioactives and consistent quality are ensured by selecting a specific chemotype of the plant and harvesting the fruits at a certain age,” noted Kalidindi.

Cardiovascular claims on Capros are supported by eight randomized, double blind, placebo-controlled clinical studies, some of which are published in peer-reviewed journals.

Maypro’s Lifton pointed to two heart-healthy, fruit-derived ingredients: Oligonol and Careless.

“Oligonol, a powerful antioxidant extract from lychee fruit and green tea, works to improve cardiovascular health a number of ways—first, by increasing levels of nitric oxide to dilate blood vessel and improve blood flow; Oligonol also reduces levels of cytokines that cause inflammation and fights inflammatory oxidation of free radicals,” said Lifton.

“The question of why we age has puzzled experts for centuries,” Lifton observed. “Recently, however, scientists have become aware of certain ‘switches’—namely SIRT1 and AMPK—that control a host of biological systems, including metabolism and cardiovascular health which tend to lose efficiency as the body ages.” Careless, a proprietary mango extract, has been “shown to keep these switches running properly.”

Marine Oils

Laval, Quebec-based supplier Neptune Technologies and Bioressources helped develop the krill oil category, and offers a new Neptune Krill Oil (NKO) formula geared to heart-health called NKO Beat.

The company added CoQ10 to its NKO formula to make NKO Beat after research showed CoQ10 bioavailability increased by as much as 25 times in combination compared to CoQ10 alone.

“For NKO Beat, focusing on cardiovascular health, we decided on CoQ10 as the main added ingredient as it is lipid-soluble, it has strong scientific evidence and the daily dose is compatible with NKO,” explained Michael Di Cicco, technical support specialist for Neptune Technologies. “Alongside CoQ10, NKO Beat also provides high potency Vitamin B12 and folic acid, which both help support red blood cell and vascular health.”

In a 2004 clinical study looking at the cardiovascular benefits of NKO, it was observed that individuals who consumed NKO had better lipid management (lower LDL cholesterol, higher HDL cholesterol) versus the placebo group. There has been extensive research on CoQ10’s role in heart health.

“The idea of mixing the two ingredients came to us by recognizing that CoQ10 is fat-soluble, thus the combination of the two might increase the bioavailability of CoQ10 in the body compared to its powder or tablet versions,” added Di Cicco. “This was confirmed by several studies, as well as our own in vitro study using our new NKO formulations that showed the same positive results.”

NKO Beat allows the following claims: “supporting heart health”, “helping maintain cholesterol levels already in the normal range”, and “supporting healthy heart muscle,” noted Di Cicco.

Norway-based supplier Aker BioMarine AS offers Superba Krill oil that is extracted exclusively from Euphausia superba, an Antarctic krill species rich in omega-3 fatty acids.

“Superba Krill is backed by a growing evidence base,” said Aker BioMarine’s Marketing Director Becky Wright. “In fact, the majority of clinical trials conducted on krill during the last several years have featured Superba Krill.”

“Aker BioMarine sponsored the largest human study on krill that investigated the effects of Superba Krill on blood lipids in subjects with ‘borderline high’ or ‘high’ triglyceride levels,” explained Wright.

Three hundred subjects participated in this randomized, double-blind, placebo-controlled, multi-center U.S. study. The five treatment groups included a placebo group (olive oil), as well as four groups taking 0.5, 1, 2 and 4 grams of krill oil daily. Research found that Superba Krill has the ability to lower triglycerides without raising LDL in those who have borderline-high or high triglyceride levels, noted Wright, unlike what was found in some fish oil trials, where LDL was raised.

Still in the marine segment, AstaReal, Inc., a wholly owned subsidiary of Fuji Chemical Industries that is based in New Jersey, offers several extracts of astaxanthin oil derived from the freshwater micro-algae, Haematococcus pluvialis, is offered in a variety of grades to match specific product forms and applications for the nutritional, food and personal care industries. “All forms of AstaReal natural astaxanthin have been used in the over 100 clinical studies we have conducted,” said Janice Brown, technical sales/support for AstaReal. Heart health is among the areas studied.

The company’s natural algae astaxanthin production facility is based in Moses Lake, Washington.

Other research-backed cardio-supportive ingredients abound. One example is Pantesin Pantethine from Kyowa Hakko USA, which has its Americas sales office in New York.

“Pantesin is a pure and highly absorbable form of pantethine (an active form of vitamin B5) that provides safe and comprehensive support for healthy blood lipids,” said Kyowa Hakko’s Karen Todd. “Pantesin works at the cellular level, enhancing enzyme and metabolic activity to help maintain balanced cholesterol levels.”

The company carries two forms of Pantesin—a form suitable for soft gels called Pantesin LQ80 and HF55 designed for tablets and capsules.

“In addition to Pantesin we also manufacture the amino acids arginine and citrulline that also support heart health by increasing blood flow and nitric oxide production,” added Todd. “We have a patent on the combination of arginine and citrulline that supports a rapid increase in blood arginine levels—recently, we filed a patent application for the combination of citrulline with our Setria glutathione that will sustain blood arginine levels and increase nitric oxide production.”

Kaneka Nutrients focuses more on vitamin formulations.

According to Andrew Shea, “Kaneka manufactures both Kaneka Q10 and Kaneka Ubiquinol—both are high-quality, heart-healthy forms of CoQ10, although most of our customers purchase the more advanced ubiquinol form of CoQ10.”

“Kaneka is the only manufacturer of yeast-fermented, naturally derived CoQ10, which is bio-identical to endogenously produced CoQ10. Kaneka Q10 is supported by more than 30 years of manufacturing, safety, toxicological and clinical studies,” added Shea. “Please note that the main studies Kaneka uses to support its structure function claims are human studies demonstrating the health benefits of CoQ10 and ubiquinol in addressing oxidative stress and other conditions that can impact the performance of the heart.”

Cardio Segment: Take Heart

The experts we spoke to believe that there is real reason for optimism in the cardio-health market for ingredients and finished products.

“Heart-healthy ingredients have the potential to reach more than $3 billion by 2020,” said Aker BioMarine’s Becky Wright. “Innovation in the heart-health category will push forward with new delivery formats and combination products, and we intend to be there to ride this wave well into the future.”

Natreon’s Aparna Kalidindi is hopeful, as well.

“The next year and the near future look bright for heart-healthy ingredients that are backed by sound science and solid clinical evidence,” Kalidindi predicted.

Maypro’s Lifton said he sees the convergence of disease and aging as opening the door for continued growth.

“Given the high incidence of heart disease, the aging population and the continued diet and lifestyle challenges facing Americans and people all over the world, we believe that this market will continue to grow dynamically,” said Lifton. NIE

For More Information:
Aker BioMarine, (206) 855-6736
AstaReal Inc., (609) 386-3030
ExcelVite, (732) 906-1901
HP Ingredients, (877) 437-2234
Kaneka Nutrients, (866) 888-1723
Kyowa Hakko USA, (800) 596-9252 or (212) 319-5353
Maypro Industries, (914) 251-0701
Natreon, (732) 296-1080
Neptune Technologies, (888) 664-9166 or (450) 687-2262
TR Nutritionals, (404) 935-5761

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