An aging population is leading the demand for bone health supplements, and manufacturers are meeting this need with ingredients that enhance basic calcium.

Manufacturers and ingredient suppliers are working to keep up with the demand for bone health supplements from the ever-growing elderly population. “We believe that the bone health category will continue to grow in the coming decades,” said Hartley Pond, vice president of technical sales at Illinois-based FutureCeuticals, Inc., which offers fruit-, vegetable-, and grain-based powders and extracts, as well as probiotics and food-based antioxidants. “In the United States, China, Japan, and many E.U. countries, there is an unprecedented growth of the elderly population and our industry will need to find solutions to help maintain bone health.”

The Baby Boomer generation is embracing a physically active lifestyle that requires good bone health and targeted nutrition, said Pond. “No previous generation had the opportunity to ‘play hard’ so late in life, and [they] want to make the most of it. Healthy bones are critical to … being able to run, bike, ski, play tennis and golf, and with that, Baby Boomers are going to be very focused on selecting nutritional products that can help maintain strong bones and joints,” he added. Bone health is important not only to support an active lifestyle, but is also implicated in the health of the entire body.

Bones provide structure and support, and also protect the organs, anchor muscles and store calcium, according to the Centers for Disease Control and Prevention (CDC).

An estimated 75 million people in Europe, the U.S. and Japan have osteoporosis, according to Peter Wisler, vice president of sales and marketing at Kappa Bioscience (Oslo, Norway), represented through Xysto Solutions in the U.S and specializing in vitamin K2 MK-7. Osteoporosis, which means “porous bone,” is a disease of the bones where too much bone is lost or not enough new bone is made. As a result, bones become brittle and may break easily.

Approximately one in two women and up to one in four men aged 50 and older will suffer an osteoporosis-related bone fracture, resulting in $19 billion in health care costs every year, according to the National Osteoporosis Foundation (NOF). Symptoms of osteoporosis include back pain caused by fractured or collapsed vertebra, loss of height over time, a stooped posture, and increased risk of bone fracture, the Mayo Clinic reported.

If bone health issues are not addressed correctly, it is likely to have “epidemic” consequences for a majority of the aging population, according to Wisler. This would not only impact quality of life, but could also become a leading cause of mortality. “Just a small improvement in bone health may have large positive implications in public health budgets and increase longevity and quality of life in individuals,” he added.

Vitamin K2 to Aid Absorption

Calcium and vitamin D3 are by far the most popular bone health supplements, and these nutrients’ ability to aid in the uptake of calcium has been well documented, according to Wisler. “However, in order to secure an optimal bone building process, another vitamin, namely vitamin K2, is needed.”

Vitamin K2, the newcomer on the bone health scene, has been shown to be involved in the activation of the bone-building protein osteocalcin by helping bring calcium into bone tissue. “Vitamin K2, vitamin D3, and calcium work in concert for building strong bones—the ‘triessentials’ for bone health,” Wisler said.

The importance of vitamin K2 has been demonstrated in a placebo controlled trial in postmenopausal women. And vitamin MK-7 (menaquinone-7, aderivative of vitamin K2) in dietary supplementation doses was shown to improve bone quality, including bone strength compared to placebo.

Vitamin K2 has begun to catch on in the market. “The bone health market continues to grow on a strong trajectory [and] vitamin K2 MK-7 is proven as one of the most exciting new ingredients in this category,” said Wisler. “Our market in the U.S. has almost doubled year on year over the last few years, which is encouraging and a strong indicator of future growth.” Kappa Bioscience has recently launched K2VITAL Delta, a micro-encapsulated and double coated MK-7 product suitable for use in formulations that contain minerals and other vitamins to avoid production and shelf life losses.

Since vitamin K2 aids in the absorption of calcium, it may be interesting those who are concerned about recent media coverage of the safety of calcium supplementation. Recent meta-analysis data suggested that high calcium intake with or without intake of vitamin D might increase the risk for cardiovascular disease (CVD) , said Wisler. Thus, the question has been raised whether high intake calcium may be harmful.

The problem is, once calcium gets taken up from the intestine, it travels aimlessly in the blood circulatory system, risking deposition on arterial walls and other soft tissue cells, Wisler said. “The solution could be simple: combining calcium and vitamin D3 with vitamin K2. [Vitamin K2] is involved in calcium regulation by securing that calcium is prevented from depositing in the arteries and brought into bones,” he added.

Recent clinical studies show that vitamin K2 activates matrix-GLA protein (MGP) in the vessel wall. In its activated form, MGP is a strong inhibitor of vessel calcification. Thus, vitamin K2 has a dual role; increasing the incorporation of calcium into bones as well as preventing calcium from depositing in the arteries, causing stiffening, said Wisler.

“The knowledge that vitamin K2 M7 (and it has to be MK-7 because it has the longest half-life of all the vitamin Ks and therefore stays in our blood circulatory system long enough to reach extra hepatic tissues) is needed to carboxylate vitamin K-dependent protein in order to avoid arterial calcification and prepare calcium for deposition into the bone mass, is a huge step forward in the global health scene for bone and cardio concerns alike,” Wisler explained. “Knowing this, why would you place yourself at heightened risk by not using vitamin K2 MK-7? It is this belief that drives sales so progressively towards mainstream application.”

NattoPharma specializes in the research of vitamin K2 and MK-7, as well as in the technology and production of MK-7 for global use in supplements and foods, according to Eric Anderson, global vice president of marketing at NattoPharma USA in New Jersey. The company’s vitamin K2 ingredient is patented and branded globally as MenaQ7.

“K2 is the ‘forgotten vitamin’ as vitamin K1 is adequate in the Western diet,” Anderson said. “Just as different B vitamins offer different benefits, vitamin K2 plays a different role than K1 in supporting bone health and cardiovascular health, and these benefits are just now becoming known.” According to Anderson, new research and technology of vitamin K2, i.e. MenaQ7 Crystals, shows preservation of bone health.

Vladimir Badmaev, MD, PhD, and head of R&D at NattoPharma ASA in Olso, Norway, also addressed the recent studies on calcium, such as the results of the 2013 JAMA-published study that indicated that supplemental calcium and vitamin D might be detrimental to cardiovascular health due to possible arterial calcification.

“In view of the role of vitamin K as one of the most important biological compounds regulating calcium in the body, and the above cited three-year clinical study, the new paradigm for supplemental calcium emerges, i.e. the guidelines for calcium supplements may have to be revised, and calcium and vitamin D supplements may need to be complemented with vitamin K2 due to vitamin K2’s increasingly recognized role as a calcium chaperone,” Badmaev said.

This emerging trend with vitamin K supplemental use has been further supported by the most recent clinical study in patients with chronic renal disease, who were evaluated for the cardiovascular effects of oral administration of vitamin K2 (MenaQ7 brand) plus vitamin D, or vitamin D alone.2 In this six-month study, the progression of coronary artery calcification index (CAC) and common carotid intima media thickness (CCAIMT)— both markers of calcium deposits in the arteries, detected with computerized tomography—showed a slower progression of the calcification in the vitamin K2/vitamin D group than detected in the vitamin D-alone group of patients, according to Badmaev.

Further, a current study of MenaQ7 provided evidence for the first time that regular intake of as little as 180 mcg of vitamin MK-7 daily for at least three years improves chances of better health and quality of life by preventing age-related bone weakening, said Anderson. “The clinical information from the three-year study of MenaQ7 can motivate a person, especially Baby Boomers and the younger Generation X (in their mid-30s and 40s) to use MK-7 daily,” Anderson said. “Both of these generations are science- driven and want to be ‘forever young;’ taking daily vitamin K2 today and every day can make them feel young and healthy years from now.”

The Role of Inflammation

Bone health problems can also stem from inflammation, according to new research. “Several large clinical studies have specifically shown that levels of inflammatory biomarkers, such as Creactive protein, interleukin-1, iner-leukin- 6 and tumor necrosis factor alpha, are independently and inversely associated with bone mineral density,” Pond said. “FutureCeuticals believes that calcium and vitamin D formulations may be enhanced by the addition of ingredients which addresses inflammation directly related to bone absorption.”

To aid in bone health, FutureCeuticals offers FruiteX-B Calcium Fructoborate, the company’s flagship product in this area. Pond cited the growing body of evidence that bone loss is fueled by age-related inflammation, or “inflammaging,” as opposed to simply being a result of a basic lack of dietary calcium, vitamin D, and age-related hormone levels. “A paradigm shift in our approach to calcium supplementation, and a better understanding of bone health factors presents new opportunities for more compelling bone health formulations built with calcium in amounts aligned with customary intake levels,” he added.

FruiteX-B has been shown to reduce inflammatory markers implicated in inflammaging. “In our work with regard to Joint and Flex applications, we have observed that FruiteX-B down regulates several inflammatory markers that have been associated with bone loss, and we are currently studying this relationship,” Pond said.

Calcium From Eggshell

While there are other ways to improve bone health beyond calcium, the mineral is still an important part of maintaining good health. According to a 2013 consumer survey conducted by the Council for Responsible Nutrition (CRN), 68 percent of U.S. adults reported taking dietary supplements within the past 12 months, and of that group, 18 percent took calcium. “Calcium remains the mainstay of bone health ingredients, and new sources of calcium continue to be introduced to the marketplace,” said Nena Dockery, technical services manager at Missouri-based Stratum Nutrition, a company that focuses on science-supported specialty ingredients. The recommended daily intake of calcium is 1,000 mg, and higher for certain populations.

Calcium carbonate is the most widely utilized calcium source because of its low cost, high natural content of elemental calcium and minimal processing needed to extract the pure calcium, Dockery said. “However, calcium carbonate is mined or retrieved from marine environments and may be contaminated with heavy metals,” she added. “Therefore, extensive testing of the raw materials and dependable methods to remove any heavy metal contamination are necessary to produce a safe product.”

Hydroxyapatite is another form of calcium found in nature, and supplemental forms are typically derived from bovine bones. In this case, lead contamination is often an issue, especially in older animals, Dockery explained. “Most non-carbonate sources of calcium, such as calcium citrate and calcium maleate are prepared in the laboratory. They contain considerably less elemental calcium, necessitating a higher dose.”

Another source of calcium, which may avoid sustainability and contamination issues, is eggshell. Eggshell as a source of calcium has yet to gain the recognition of other, more popular, sources of calcium, such as calcium carbonate. Stratum Nutrition offers eggshell calcium under the brand name ESC. According to Dockery, ESC is a minimally processed calcium form derived from sustainable food sources, like chicken eggshells.

ESC is domestically produced ingredient that contains between 35 and 40 percent elemental calcium, along with transport proteins that help facilitate intestinal absorption and may also help explain the lack of detrimental side effects often reported with some other source of calcium, Dockery said. It also contains heavy metals at levels that are well below California Prop 65 levels, which are the most stringent in the industry.

“ESC is an ideal form of calcium for combining with other bone support nutrients,” Dockery noted. “It is derived from a food source (the chicken eggshell), and contains an amount of calcium that makes it easy to formulate into products requiring fewer dosage units. It doesn’t require extra steps to remove heavy metals and naturally contains support proteins to aid in absorption and utilization in the body.”

Delivery Methods

The most popular bone health brands are primarily utilizing solid dose delivery, according to FutureCeuticals’ Pond. “However, new delivery options such as gummies, ready-to-drink beverages and shots, bars and MRP products are all also being used, and should increase in popularity in the coming years.”

As for vitamin K2, according to Wisler, the main delivery methods include tablets, capsules and food in combination with vitamin D and calcium, as well as multivitamins or in combination with omega-3s. Foods, such as milk and yogurt and sports drinks are also merging markets for vitamin K2, he added.

NattoPharma’s Badmaev agreed, adding that there is an emerging trend for development of functional foods with active ingredients like vitamin K2. “The challenges to efficacious supplements and functional foods 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 delivery,” he said.

And when it comes to calcium, Stratum Nutrition’s Dockery pointed out that it is important for manufacturers to keep in mind that individuals may be getting bone support nutrients such as calcium, vitamin D and magnesium from other sources. “Therefore, in formulating, each unit (capsule, tablet or chew) should probably contain no more than half of the RDI of the nutrients,” she said. “In this way, individuals can adjust their dosing to match consumption of the ingredients from other sources.”

As for medicinal food development, Badmaev said the objective should be product innovations that feature enhanced nutrient bioavailability and that come in forms that are more “fun” to the consumer. “The ultimate goal of this industry is to develop products with good compliance and outstanding and proven quality in the treatment of a health condition,” he said. “If one has to take the liquid/smoothie/etc. That doesn’t taste good, or if their doctor’s tests are not showing measurable benefit due to poor bioavailability of the product, most consumers and practitioners will abandon it.”

References:

1 Knapen et al 2013.

2 Kurnatowska & Nowicki et al. 2013; 50th ERA-EDTA Congress.

Extra! Extra!

Visit www.niemagazine.com to read CRN’s take on a recent vitamin D criticism.

FORMOREINFORMATION:

■ FutureCeuticals, (888) 452-6853
■ Kappa BioScience, (973) 975-4224
■ NattoPharma, (609) 454-2992
■ Stratum Nutrition, (888) 403-5039