The Heart Of The Matter

As heart disease remains the No. 1 killer in the U.S., consumers are in search of heart health supplements that utilize natural ingredients backed by clinical research.

About 600,000 people die of heart disease in the U.S. every year, according to the Centers for Disease Control and Prevention (CDC), and coronary heart disease is the most common cause, killing about 380,000 people a year. Heart disease is the leading cause of death in the U.S., which has led to a growing market for heart health supplements, according to Becky Wright, communications and marketing manager at Washington-based Aker BioMarine Antarctic US, a company that specializes in sustainable harvesting of krill and the development of krill-derived biotech products.

Consumers of all ages are concerned about heart health, from young adults interested in supplements that will pay off in the long run, to Baby Boomers who are looking to improve their health as they notice signs of aging. Symptoms of an unhealthy heart include high cholesterol, inflammation and circulation issues, all of which can lead to heart disease. But several ingredients have been shown to help improve these problems.

One ingredient known for its benefit to heart health is krill oil, which is high in omega-3 fatty acids. “Krill is actually beneficial for all age groups, especially since omega-3s are important nutrients throughout the lifecycle,” said Wright, adding that krill oil is currently the fastest growing omega-3 category due to its appeal to so many different types of consumers.

Another heart healthy nutrient is vitamin K2, which has been shown in several studies to protect against arterial calcification, according to Vladimir Badmaev, MD, PhD, and head of R&D at Norway-based NattoPharma ASA, a company that offers the branded vitamin K2 ingredient, MenaQ7.

Lowering “Bad” Cholesterol 

Due to the “standard American diet” of fatty and processed foods, many consumers struggle with “bad” cholesterol, or LDL (low-density lipoprotein). High levels of LDL can lead to heart disease, as it tends to deposit on the walls of arteries, leading to plaque and eventually a blockage. Some studies have shown that bad cholesterol can be lowered when omega-3 oil is added to the diet.

According to Wright, the omega-3 oil found in krill, such as Aker BioMarine’s Superba Krill, has been shown to promote cardiovascular health by decreasing LDL cholesterol and high triglyceride levels, while simultaneously increasing amounts of “good” HDL (high-density lipoprotein) cholesterol.

“In a soon-to-be-published study, researchers investigated Superba Krill’s ability to lower triglycerides without raising LDL (which has been the case in some fish oil trials) in those who have borderline high or high triglyceride levels,” said Wright.

In the randomized, double-blind, placebo-controlled, multi-center U.S. study, 300 participants with borderline or high triglyceride levels were split into five treatment groups including a placebo group (who were given olive oil), as well as four groups taking 0.5, 1, 2 and 4 g of krill oil daily.

“This study showed a triglyceridelowering effect, without impacting LDL levels,” said Wright. “Study authors concluded from their findings that Superba Krill oil is effective in reducing cardiovascular risk factors important in the treatment of dyslipidemia.” 

Superba Krill is a pure, natural source of EPA and DHA omega-3 fatty acids and the naturally occurring antioxidant astaxanthin. Aker BioMarine also recently launched a krill powder version, Superba KRILL POWDER, which contains a significant amount of protein, according to Wright. “It is produced aboard a vessel certified by the Marine Stewardship Council (MSC) using a patent-pending technology,” she said.

Omega-3 oil consumption remains at the top of consumer’s lists as they seek out its overall health benefits, said Wright, adding that omegas are also one of the most clinically researched nutrients (Fig. 1).

“More consumers globally are seeking out various vitamins and supplements to help contribute to their overall health, especially with omega-3s,” said Wright. “And as more and better sources of these fatty acids are needed to meet this demand, it is important that consumers are properly informed of the best options on the market, one being krill.”

When working with krill oil, such as Aker BioMarine’s Superba Krill, manufacturers should first look at products that come from marine sources and that Are also sustainable and traceable, said Wright. “Very few marine omega-3 ingredients are sustainable, and almost none are traceable. One exception is Superba Krill, which is both sustainable and traceable,” she added.

Wright also pointed out the differences between krill oil and fish oil when it comes to delivering the benefits of omega-3s, and how the source of omegas can impact the delivery of these fatty acids to the body’s cells and tissues. “In particular, krill oil’s omega-3s are bound to phospholipids and therefore undergo different digestive and distribution routes versus fish oil when they get into the body. Because phospholipids are integral parts of cell membranes, krill’s omega-3 exhibit preferential uptake in the cells,” she said. “Fish oil’s omega-3s, on the other hand, must be converted in the liver before they are available to the body’s cells. The increase cellular uptake has strong implications for the deposition in important tissues and organs such as the brain and the heart.” 

The Benefits of Vitamin K2 

Vitamin K2 also plays a role in heart health, such as preventing arterial calcification, as mentioned previously. A recent study on NattoPharma’s MenaQ7 brand of vitamin K2 showed promise in preventing these plaques from building up.

“It does this by activating matrix Gla protein, which helps recognize circulating calcium and prevents it from being in-build into arterial walls,” said NattoPharma’s Badmaev. “Calcium, over time, can build up into plaques, like a cement on the walls of arteries, causing them to stiffen and become inflexible. Arteries need to be flexible in order to ‘go with the flow’ of blood to and from the heart.” 

The study1 on MenaQ7 was recently published detailing its three-year trial in healthy post-menopausal women, which showed for the first time benefits of nutritional vitamin K2 compared to a placebo group in preventing age-related stiffening of arteries, Badmaev said. “The current three-year clinical study of MenaQ7 provides evidence that regular intake of as little as 180 mcg of vitamin MK-7 daily for at least three years improves our chances to have better health and quality of life by preventing age-related bone weakening, cardiovascular deterioration and preventing lean body mass deterioration.” 

Badmaev compared the MenaQ7 intake to the already widely recommended intake of low-dose baby Aspirin. “Taking daily vitamin K2 today and every day can make you feel young and healthy years from now,” he said.

The Role of Inflammation 

Bad cholesterol and arterial stiffening are widely accepted causes of heart disease. But according to the CDC, in an article published in Circulation, the role of inflammation in heart disease has become further established over the past decade or more in theories describing the atherosclerotic disease process. Atherosclerotic plaque might be considered to be an inflammatory response to injury, usually caused by smoking, hypertension, atherogenic lipoproteins and hyperglycemia. And according to the American Heart Association (AHA), inflammation is common for heart disease and stroke patients and is thought to be a sign of atherogenic response.

“Cardiovascular disease, a leading cause of mortality in the world, is no longer considered a disorder of blood lipids, but rather a disease process characterized by low-grade inflammation of the vascular lining (endothelial cells) and an inappropriate ‘wound healing response’ of the blood vessels,” said Badmaev.

NattoPharma recently discovered an anti-inflammatory property of MK-7, which inhibits pro-inflammatory markers produced by white blood cells (monocytes).

“This finding may be an important contribution to better understand the mechanism of MK-7 in clinical studies showing beneficial results in cardiovascular and bone health, since cardiovascular disease and osteoporosis are major age-related health conditions characterized by chronic inflammation,” Badmaev added. “NattoPharma’s study may provide an additional explanation on the role of inflammation and preventing inflammation with vitamin K2 as an important mechanism of this reemerging vitamin in sustaining health and preventing disease.” 

The omega oils found in krill, when added to the diet, may also help prevent inflammation in the body, according to Aker BioMarine’s Wright. “In addition to Its heart health benefits, krill helps promote healthy inflammation levels. In particular, the phospholipid omega-3s in krill support a healthy inflammatory response, helping to normalize C-reactive protein (CRP) levels,” she said.

Industry Tips 

When it comes to choosing ingredient suppliers, Badmaev suggested manufacturers find companies that can provide a portfolio of original science demonstrating the company’s clear efficacy at specific dosages. “For example, our three-year study showing clear bone and cardiovascular health benefits used a 180 mcg dose of MenaQ7,” he said.

Badmaev also suggested that manufacturers ensure their suppliers are working hard to continually educate the marketplace, and will be willing to provide the tools necessary to carry this message to their audience.

Finally, Badmaev recommended finding a supplier that will have a number of formulation specialists on hand who can ensure a concept will be viable from the manufacturing processes through human consumption.

New Interest

Manufacturers may be interested to hear there is rapid growth in the medicinal food ingredient category, according to NattoPharma’s Badmaev, who has seen interest growing in ingredients like multifunctional K2 spurred by the popularity of anti-aging and muscle-building drinks, like Ensure.

“The medicinal food category evolved from growing need for the specific dietary management of a disease or a health condition with a specifically formulated food,” he said. “Medicinal food would be defined as a food that is formulated to be consumed or administered orally under the supervision of a physician.

“It is important to mention the distinct position that medicinal food occupies among health care products, before discussing health conditions which can potentially be alleviated or treated with the medicinal food,” he added. “The challenges to efficacious ingredients are due to regulatory obstacles that can be resolved by a solid research program, and formulation of the active ingredients, like vitamin K2, into a stable, nutritious and attractive form of food delivery.” 

Overall, Badmaev predicts the industry will soon see less pills and more medicinal foods in the form of smoothies- on-the-go or other beverages that seem to be gaining velocity in consumer use. 

Reference: 

1 Knapen et. Al, 2013

Responding to FDA’s 60-day Trans Fat Comment Period

The U.S. Food and Drug Administration (FDA) has made a preliminary determination that partially hydrogenated oils (PHOs), the primary source of artificial trans fat in processed foods, are not “generally recognized as safe” (GRAS) for use in food, according to an FDA press release from November 7, 2013. FDA opened a 60-day comment period to further reduce trans fat in processed foods.

After the 60-day comment period, FDA will determine if PHOs are not GRAS, and if so, the oil will not be allowed for use in food.

“We are thrilled that the FDA is being proactive and finally taking action against such a damaging manmade ingredient,” said NattoPharma’s Vladimir Badmaev. “Modern diets contain ready-made foods and there’s no getting around that. The systemic removal of transfats should, through time, have a positive impact on cardiovascular status among Americans, giving them better heart-health status. And that’s a very good starting point to improve cardiovascular health through other means and options.” 

Naturally occurring unsaturated fats are composed of fatty acids with hydrocarbon chain double bonds in the “cis” configuration, with the hydrogen atoms on the same side of the double bond, Badmaev explained. But the industrial hydrogenation of plant oils reconfigures the “cis” double bonds into the “trans” configuration. Trans fat cannot be properly utilized in the body, provides no known benefit to human health and is more detrimental to health than saturated fat. “Both saturated fat and trans fat increase levels of LDL cholesterol … but trans fat also decreases the HDL cholesterol … and increases levels of pro-inflammatory C-reactive protein (CRP),” he said.

Trans fat is a proven cause of cardiovascular disease including heart disease, stroke, kidney failure, peripheral vascular disease (PAD) and chronic degenerative conditions, as well obesity, according to Badmaev.

FDA has required the industry to declare trans fats on food labels since 2006, leading many companies to reformulate to reduce the fat in food, but a number of products still contain PHOs. If a final decision is made, PHOs would be phased out of foods over a number of years, and could possibly prevent up to 7,000 deaths from heart disease a year.

For more information, visit www.fda.com.

AHA Statin Recommendation Draws Criticism

The American Heart Association (AHA) and The American College of Cardiology (ACC) have recently released new guidelines for the treatment of blood cholesterol using statin drugs. The new guidelines uses a calculator to identify four major groups of patients who might benefit most from statin use, including patients who have cardiovascular disease; patients with an LDL cholesterol level of 190 mg/dL or higher; patients with type 2 diabetes who are between 40 and 75 years of age; and patients with an estimated 10-year risk of cardiovascular disease of 7.5 percent or higher who are between 40 and 75 years of age.

Doctors have expressed their concerns with these calculations, stating that it could lead millions of people to unnecessarily take cholesterol-lowering statin drugs, according to an article in The New York Times. Others have suggested the new guidelines are set in place simply to sell more drugs.

“There will be a faction, and a rather significant one at that, who will want to protect their cardiovascular function through other, more natural means,” said NattoPharma’s Vladimir Badmaev. “For brand marketers, anticipating this new wave is a good idea. They may want to create new formulas, tweak existing formulas, and ramp up consumer marketing and education programs.”