An estimated 17.5 million people died from cardiovascular diseases (CVDs) in 2012, representing 31% of all global deaths, according to the World Health Organization (WHO). Several medical conditions and lifestyle-related issues can put people at a higher risk for heart disease, including diabetes, obesity, poor diet, and physical inactivity, which are all too common in modern Western society.
High blood pressure, high LDL cholesterol, and smoking are key risk factors for heart problems, and about half of Americans (49%) have at least one of these three variables, according to the Centers for Disease Control and Prevention (CDC).
In fact, data from the American Heart Association indicates that about 85 million Americans—one out of every three adults over age 20—have high blood pressure, and nearly 20% don’t even know.
A Top Health Concern
The market for heart health supplements is about $2.5 billion, according to Nutrition Business Journal. Additionally, a 2014 Gallup study on the U.S. vitamin and dietary supplements market, noted that among the top condition-specific products that consumers purchase, 40% are to help maintain healthy blood pressure levels and 38% are to prevent heart disease.
“There is a huge need to teach the general population about the importance of taking proactive measures to take care of their heart, such as taking supplements,” said James Kennedy, PhD, president, Polyphenolics, a division of Constellation Brands, Madera, CA.
The market for heart health products has been relatively stable, according to Pam Stauffer, global marketing programs manager, Cargill, Minneapolis, MN. In fact, they accounted for nearly 13% of the overall supplement market in 2016, according to data from Euromonitor International.
A recent study from HealthFocus International found that 51% of consumers surveyed were extremely or very concerned about cardiovascular health, and 41% had similar feelings related to high cholesterol. “For many consumers, that concern translates into interest in purchasing products with heart health benefits,” said Ms. Stauffer. “The same consumer study found 55% of both men and women were extremely interested in purchasing foods or beverages that could help maintain a healthy heart. Not surprisingly, consumers in their 40s, 50s and 60s reported higher levels of interest than younger survey participants. Regardless of gender or age, these heart health shoppers actively seek out dietary measures to manage heart disease risk, including foods and drinks that lower cholesterol.”
Becky Wright, marketing and communications director, Superba, Aker BioMarine Antarctic US, Metuchen, NJ, said the market for heart health supplements is “thriving.” According to recent research by Innova Market Insights, the number of supplements with a heart health positioning grew 71% from 2011 to 2015. “Predictions also point to heart health as a key trend to watch in the near future,” she said.
However, the heart health market presents many challenges, noted Deanne Dolnick, science director, TR Nutritionals, Alpharetta, GA. “This is an extremely tough category, because the average person does not take supplements proactively for heart health, and by the time a problem arises, medications are prescribed. It doesn’t help that the industry is not able to label dietary supplements for heart health in a way that’s appealing to the average consumer. Why would a consumer want to take a product where the label reads that it is meant for people who already have healthy cholesterol levels? It’s a real problem and certainly hinders the growth of the category.”
Companies should think more about what motivates the average American to take a category-specific supplement, she added, such as “a prominent news story, a recent friend or family member that is facing a health problem or a disturbing visit with the doctor. I think that prophylactic use of supplements for heart health is not the norm for the average adult.”
Still, cardiovascular health is becoming a concern across varying age groups, noted Scott Steinford, president, CoQ10 Association and the Natural Algae Astaxanthin Association. “According to a statement released by the journal Circulation, most children in the United States between the ages of 2 and 19 years do not meet the American Heart Association’s classification of ideal childhood cardiovascular health. As more attention is directed toward the importance and deficiency of heart health, more emphasis on supplementation is likely to be recognized.”
The market for heart health products today encompasses a range of ingredients, such as CoQ10 for statin-induced myopathy and cardiovascular health, and natural astaxanthin for energy and exercise support. “The combined reality of the prominence of heart disease and the proactive efforts to prolong quality of life to unprecedented expectations continue to drive demand for heart health products,” said Mr. Steinford.
Ultimately, the main buyers of heart health products trend toward older baby boomers, noted Elyse Lovett, marketing manager, Kyowa Hakko U.S.A., Inc, New York, NY. “Buyers that have condition-specific needs, like reduction in cholesterol and triglycerides, are attracted to those heart health type formulations,” she said.
However, boomers and seniors aren’t the sole beneficiaries of these products, Ms. Wright said. “Everyone can benefit from good heart health habits to prevent issues in the future, and fortunately there are options for those looking to be proactive. The journey to cardiovascular disease can start as early as childhood, and according to a new report from the American Heart Association, few children meet all of the criteria for ideal heart health. That being said, proactively caring for your heart can and should start early on.”
A comprehensive meta-analysis published in the Mayo Clinic Proceedings in January, which was sponsored by the Global Organization for EPA and DHA Omega-3s (GOED), concluded that increased intake of omega-3 EPA and DHA could reduce the risk of coronary heart disease (CHD) for at least one in four Americans.
Among randomized controlled trials (RCTs), there was a statistically significant reduction in CHD risk in higher risk populations, including 16% in those with high triglycerides and 14% in those with high LDL cholesterol. The study also found a non-statistically significant 6% risk reduction among all populations in RCTs, a finding supported by a statistically significant 18% reduced risk of CHD among prospective cohort studies.
“What makes this paper unique is that it looked at the effects of EPA and DHA on coronary heart disease specifically,” said Dominik Alexander, PhD, MSPH, lead author and principal epidemiologist for EpidStat. “The 6% reduced risk among RCTs, coupled with an 18% risk reduction in prospective cohort studies—which tend to include more real-life dietary scenarios over longer periods—tell a compelling story about the importance of EPA and DHA omega-3s for cardiovascular health.”
The study reviewed 18 randomized controlled trials (RCTs) and 16 prospective cohort studies, with 93,000 and 732,000 subjects, respectively. It examined outcomes such as myocardial infarction, sudden cardiac death and coronary death. The analysis also compared the results of RCTs, which explore interventions under strict clinical conditions, to those of prospective cohort studies that are observational, and followed larger populations for longer periods of time.
“There are important public health implications related to reducing the risk of coronary heart disease, and therefore we are encouraged by the results of this comprehensive analysis,” said Harry Rice, PhD, vice president of regulatory and scientific affairs for GOED. “It’s also important that the observed risk reductions were even stronger in patient populations with elevated triglycerides and LDL cholesterol levels, two risk factors that affect more than one quarter of the American population.”
“The results confirm that increasing omega-3s is a healthy lifestyle intervention that can contribute towards reductions in CHD risk,” added Adam Ismail, executive director of GOED. “Remember that increasing omega-3 intakes is basically just improving the quality of one’s diet slightly, like reducing the amount of sodium or increasing your dietary fiber. It is a simple, inexpensive, and achievable change that most consumers need to make to optimize their health.”
Additionally, the American Heart Association published a science advisory on fish oil supplementation in March, which updated its 2002 scientific statement. The report concluded that treatment with omega-3 supplements is reasonable for secondary prevention of coronary heart disease and sudden cardiac death in patients with prevalent CHD and for outcomes in patients with heart failure. The AHA made no recommendation on omega-3 supplementation for primary prevention of CHD, heart failure, or atrial fibrillation, stating that not enough evidence existed yet to draw a conclusion.
“While the report does not recommend supplementation for the general population, it is still positive for the omega-3 space overall,” said Mr. Ismail. “The advisory reinforced that omega-3s are important for cardiovascular function and affirms that treatment with EPA and DHA supplements is appropriate for some specific populations.”
The update was a bit more specific about where omega-3 supplements may be valuable, he added, but it did not significantly change the prior AHA recommendation. “The AHA never recommended supplementation for the general population, only for those with diagnosed CHD,” Mr. Ismail noted. “The panel made no recommendation on whether EPA and DHA supplements could prevent cardiovascular events in the general population because a large trial is currently underway to assess this. They did not say there was no effect; they essentially said let’s wait and see.”
Dr. Rice added the report’s findings underscore that while “omega-3s are the most clinically researched nutrients in human nutrition, we are still at the beginning of understanding all the roles EPA and DHA play in the body. There were multiple areas of cardiovascular health where the panel noted that no research has yet been conducted.”
Andrea Wong, PhD, vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN), said science demonstrating the benefit and safety of omega-3 fatty acids for heart health is well established and the AHA advisory reaffirms this fact. “Even though this advisory focused on major disease endpoints, we should not discount the significant amount of research that supports the role of omega-3s on other relevant endpoints, such as reducing triglycerides and blood pressure, which potentially help healthy adults prevent cardiovascular disease.”
The bottom line is that omega-3s are extremely important heart health ingredients, Aker’s Ms. Wright added. “Research shows that omega-3s maintain blood pressure and cholesterol levels (within a normal range), help promote a regular heart rhythm and support normal blood clotting processes, all helping to keep both the heart and its arteries healthy. Krill oil, in particular, has become the second largest commercially available source of omega-3s EPA/DHA.” These nutrients help reduce risk of cardiac death, maintain healthy blood pressure levels, and keep triglycerides within normal range, she added.
Ingredients On Trend
A recent survey from Consumerlab.com, White Plains, NY, found that fish oil, vitamin D and CoQ10 were the top three products taken among supplement users. “It is not surprising that all three of those ingredients have strong science supporting heart health benefits,” noted Mr. Steinford. “For example, the Q-Symbio Trial (Journal of the American College of Cardiology Foundation, 2014) was a 420-person randomized, controlled multi-center trial that determined ‘long term CoQ10 treatment of patients with chronic heart failure is safe, improves symptoms, and reduces major adverse cardiovascular events.’”
Abhijit Natu, marketing manager, BASF Nutrition & Health, Florham Park, NJ, noted research supports vitamin D3 for cardiovascular health. “Research suggests that vitamin D deficiency may be a risk factor for cardiovascular disease. A newly published meta-analysis in the American Journal of Clinical Nutrition showed that higher blood levels of vitamin D were associated with significantly fewer cardiovascular disease events and a lower risk of mortality from CVD. Analysis of data from 180,667 participants revealed that for every 10-ng/mL increase in blood levels of vitamin D, the risk of CVD events decreased by 10%, while the risk of dying from cardiovascular disease decreased by 12%.”
BASF also recently supported a clinical trial examining the impact of Vegapure plant sterols in soy milk on inflammation in human subjects, Mr. Natu said. “The results show improvement in various markers of inflammation, including the well known cardiovascular risk marker C-reactive protein (CRP). Recent research also shows that combinations of omega-3 and sterols have synergistic benefits on blood lipid markers of heart health. Studies show this combination dose dependently lowers both triglycerides and LDL cholesterol.”
Plant sterols have a well-established track record of reducing LDL cholesterol, said Mr. Natu. “Over 100 clinical trials have been conducted on plant sterols and related plant stanols. Plant sterols have been conclusively proven to reduce LDL cholesterol by 6-12% dependent upon dose (1-3 grams plant sterols). Plant sterols work by mimicking cholesterol in the gut and reducing intestinal absorption of the cholesterol from the diet and naturally produced by the body.”
There are over 10 clinical trials specifically on BASF’s Vegapure plant sterols demonstrating cholesterol reduction in a variety of different delivery formats. “It is exciting to see the science grow beyond cholesterol management. As researchers get a bigger-picture view from clinical trials, including areas like inflammation and genetic risk, we can develop relevant nutritional therapies,” Mr. Natu said.
Clinically shown to lower cholesterol, plant sterols are backed by an FDA-approved health claim and are recommended by the National Cholesterol Education Program (NCEP) of the National Heart, Lung and Blood Institute of the National Institutes of Health, noted Cargill’s Ms. Stauffer. The company’s branded CoroWise plant sterols are found in many foods, beverages and supplements.
“Plant sterols occur in small amounts in plant-based foods,” said Ms. Stauffer. “Since they have powerful cholesterol-lowering properties, manufacturers add plant sterols to foods and beverages to address consumer demands for heart-healthy products. CoroWise plant sterols do not affect the taste or texture of food and beverages, and can easily be added to most formulations.”
Cargill is a member of the International Plant Sterols & Stanols Association. “Member companies are working together to educate the public about the benefits of integrating plant sterols and stanols in the daily diet and to foster the implementation of healthy diet and lifestyle choices to reduce blood LDL-cholesterol. Plant sterols and plant stanols actively reduce blood LDL-cholesterol, a major risk factor for heart disease. It is important that consumers are aware that foods, beverages and supplements containing plant sterols and stanols are an available option to manage heart health and reduce cholesterol.”
According to the AHA and Go Red for Women, women may have an increased risk of cardiovascular disease at the onset of menopause, as the body decreases production of estrogen. A recent study published in Minerva Ginecologica (February, 2017), showed the benefits of Pycnogenol for alleviating various perimenopause symptoms. This was the first study to show the effects of Pycnogenol, standardized French maritime bine park extract from Horphag Research, on cardiovascular risk markers, homocysteine and CRP levels. In this study and in previous research, Pycnogenol reduced and normalized elevated cardiovascular risk factors often related to perimenopause: cholesterol, triglycerides, blood pressure and blood glucose.
In the new study, 70 female subjects between the ages of 40 and 50 years of age who reported comparable perimenopause symptoms were assigned to either a control group or a Pycnogenol group consisting of daily supplementation with 100 mg Pycnogenol—for an 8-week period. All participants were advised to follow a self-improvement routine of exercise, rest and a healthy diet. After 8 weeks, the Pycnogenol group reported significantly reduced perimenopause symptoms and exhibited decreased markers of cardiovascular risks.
Researchers tested again six months after the initial period and found significant reduction of cardiovascular risk indicators, including: significant reduction of homocysteine (47% improvement); normalization of systolic blood pressure (8% improvement); significant decrease in CRP levels (60% improvement); reduction of fasting blood glucose (9% improvement); significant reduction of oxidative stress (22% improvement); improvement of triglycerides levels (11%).
Kyowa’s Ms. Lovett said ingredients for specific conditions continue to emerge in the heart health market. For example, pantethine, a derivative of vitamin B5, maintains cholesterol levels within the normal range, with minimal side effects. Kyowa Hakko supplies the pharmaceutical-grade form branded Pantesin. “There has been evolving research on the combination of heart health ingredients,” she added. “One study showed Pantesin not only helped lower LDL and non-HDL cholesterol levels, but also maintained CoQ10 levels. And unlike some cholesterol-lowering drugs, long-term use of Pantesin does not lead to additional health risks, (Vascular Health and Risk Management, 2014).”
Polyphenolics’ Dr. Kennedy said grape seed extract (GSE) is a potent antioxidant that helps to maintain healthy nitric oxide levels. The company’s MegaNatural-BP is a unique form of GSE that has been clinically shown to help maintain healthy blood pressure levels within the normal range. “This helps support healthy vasodilation and blood flow,” he said.
TR Nutritionals’ Ms. Dolnick noted that many multi-vitamin/mineral products are including heart health ingredients. “This is a good trend. Some people only want to take one or two supplements a day and if they can get their heart health supplement along with their multi, it makes it much easier.”
TR Nutritionals has also seen a significant increase in requests for Indian botanical extracts, she added. In 2016, TR Nutritionals signed a U.S. exclusivity agreement with Prakruti Products Pvt. Ltd., a manufacturer of Indian botanical extracts. “With regard to heart health, Ashwagandha extract with 2.5% Withanolides is leading the way,” said Ms. Dolnick.
“This extract works by helping to lower CRP. High levels of this protein are associated with inflammation and more specifically heart disease. It was shown in one clinical trial to decrease cholesterol and triglycerides, as well.”
Innovations to Watch
The market for food and beverage products using heart health claims remains fragmented, according to Cargill’s Ms. Stauffer, with breakfast cereals and cereal bars accounting for a leading 19% of new product launches, per Innova Market Insights.
BASF application scientists work with customers to perfect products that resonate with consumers, including formats like small soft gels and chewables that will appeal to adult consumers who have difficulty swallowing large tablets. “Personalized nutrition, we believe, will be more than a trend and it can shape the future of our industry,” said Mr. Natu.
With many consumers suffering from pill fatigue, and product developers looking for innovative delivery methods, new and convenient product formats like shots, beverages, tinctures and gummies represent a fast-growing opportunity, according to Mr. Steinford. “Appealing to younger, on-the-go consumers, these forms may also help increase product functionality through enhanced bioavailability and better absorption.”
Aker BioMarine’s Ms. Wright said innovation is a trend to watch in the omega-3 space. Aker’s new technology platform, Flexitech, has the ability to bring new and interesting products to market, she added. “Currently this new technology can improve some of the negative aspects of krill oil like odor and taste, as well as up-concentrate its beneficial components like omega-3s and phospholipids.”
Looking forward, she said that omega-3s are a mainstay in the heart health supplements market and will continue to evolve. “During the next few years, research and education will be equally important as innovation. In order to bring more attention to the lack of EPA/DHA in our diets, Aker BioMarine created the Omega-3 Index Project in conjunction with several industry partners. Omega-3 insufficiency is actually a major global issue, costing healthcare systems around the world billions of dollars. The Omega-3 Index Project will help communicate these important messages to consumers and physicians alike while giving everyone a solution to help fulfill their omega-3 needs. By using a simple tool called The Omega-3 Index Test, everyone will be able to measure their Omega-3 Index levels before determining a plan to help set them on the right health path.”
Joseph Moritz, PhD, scientific marketing manager, BASF, said the market is likely to see more interest in sterols as adults with borderline high cholesterol look for natural options. “There is also a segment of the population that doesn’t tolerate statins and may find health benefits in sterols. As for omega-3s, compelling scientific evidence will continue to drive demand. Health-conscious consumers are well aware of the health benefits of fish, but often recognize that they don’t eat enough. So supplementing is an option that will boost the market as consumers look to fill gaps in their diets.”
Better understanding about how diet and exercise impact health, condition-specific solutions will evolve, said Dr. Kennedy. “We all have individual susceptibilities to disease. The evolution will occur when our individually-developed ‘health manuals’ will have specific dietary recommendations that can be met with supplements formulated with your health in mind.”