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Flexible and Strong

Bone, Muscle, Joint Health Bone, Muscle, Joint Health
AIDP

A shift in ingredients that address bone, muscle and joint health is underway to meet the interests of a broadening marketplace.

No matter what your age, maintaining muscle, joint and bone health is key to staying active and vital throughout life.

As for natural products, Barbara Davis, PhD RD, vice president, medical and scientific affairs with New Jersey-based PLT Health Solutions, said the market for joint health is huge and growing. She noted that consumer sales of joint health supplements topped $1.65 billion in 2013, with bone health supplements reaching nearly $1.9 billion (NBJ 2014). “Consumers trust the ability of joint and bone supplements to improve their lives with rankings for ‘extremely believable’ and ‘believable’ claims among the top in the supplement industry.”

Davis noted that, “For the past decade, glucosamine and chondroitin have dominated the market in terms of product launches. At the same time, both patent applications and scientific publications in the area of joint health have slowed—this despite the fact that new product launches in the category continue to increase globally. It can be fairly said that this market is in need of innovative ingredients to take advantage of the interest in the marketplace and respond to consumer demand.”

Dr. Aparna Kalidindi, technical sales and marketing manager with New Jersey-based Natreon Inc. added the market for bone, muscle and joint health has remained very stable with a loyal consumer base. However, over the past few years, new ingredients with new research have emerged along with a new consumer. The global market for bone and joint supplements is forecast to reach more than $9 billion by the year 2017, led by developing markets in Asia-Pacific.

Although industry members are optimistic about the future for bone, joint and muscle support natural products, health news on calcium has negatively affected the category, noted Kathy Lund, vice president of business development & marketing with California-based AIDP, Inc. “The bone health category has been declining,” she said, adding that collagen as an ingredient for joint health is growing. Collagen has been strong internationally, and now that awareness is gaining a foothold in the U.S.

Consumers are interested in the benefits of these ingredients, agreed Dr. Andrew Halpner, vice president of product development with Douglas Laboratories in Pennsylvania, adding that he believes there is a trend moving in the direction of healthy aging. “More people are interested in focusing on maintaining healthy bones and joints into their older years versus trying to address an existing problem. As a result we see people looking to be more proactive in terms of their bone and joint health. We are also seeing more people being active and exercising as they get older, and maintaining healthy bones and joints allows them to continue being active well into their later years.”

The Evolving Market

For all its benefits, there is a down-side to getting physically fit. Annie Eng, CEO of HP Ingredients in Florida said as more Americans are getting in shape by regular workouts to fitness centers, ironically, they often lose more than just weight; they often lose joint integrity via the physical stress of repetitive motion.

“Similarly, as more women are now being advised by their ob/gyns to be conscious of their bone density in their mid-30s, there has been a significant uptick in the demand for bone-nourishing supplements.”

In our later years, Xiaoming “Sandy” Chien, PhD, vice president, innovative products with HORN Nutraceuticals in California, said osteoporosis, the degenerative loss of skeletal muscle mass or sarcopenia, and joint issues are health risks that highly affect the degradation of the quality of life once people reach their golden years.

“Menopausal and post-menopausal women are still very much the target audience for bone health,” she said, but agreed that muscle and joint health markets have been expanded to young populations in addition to Baby Boomers. “Weekend warriors, young adults, male and female have increased awareness of the benefits of lean body mass due to increased scientific research. Manufacturers are targeting this new demographic with wide variety of offerings in proteins for muscle strength, and sports nutrition for muscle recovery.”

Eric Anderson, senior vice president of global sales and marketing, NattoPharma USA Inc., in New Jersey, said the company sees the supplement and natural self-care market experiencing aggressive growth in industry launches as well as consumer demand.

Anderson pointed out that according to the World Health Organization (WHO), osteoporosis currently affects some 200 million people globally. “Worldwide, one in three men are expected to suffer from osteoporotic fractures in the future, whereas lifetime risk of fracture for women is nearly one in two,” he said. “Women are more vulnerable due to two factors. First, women in general have less bone mass than men and secondly, the annual loss of bone mass in women accelerates after menopause.”

Product and Ingredient Shift

A decade or so ago if you mentioned bones and joints, the ingredients that would come to mind were calcium, glucosamine and chondroitin. “While these ingredients still maintain their popularity,” said Halpner, “there has been a shift to a much broader base of nutrients that have become associated with bone and joint health. This ranges from other vitamins and minerals including vitamin D, vitamin K2 and magnesium, to ingredients such as omega-3 fatty acids, curcumin and even collagen. The industry is gaining a better appreciation for the complex set of factors involved in supporting bone and joint health and we are therefore seeing different ingredients approach this category from different angles.”

Chien concurred, “Calcium, vitamin D and K are still the dominant ingredients for bone health; glucosamine and chondroitin for joint; and proteins for muscle. The big shift is the awareness of vitamin K2 and its importance to bone health via the uptake of calcium.” She noted that new guidelines now also call for increased vitamin D daily intake. The Institute of Medicine (IOM) recommends daily intake of 600 IU for ages 7 years and older and up to 4,000 IU/day.

In addition, formulations with joint support herbs such as turmeric and ginger are now on the rise, and Kalidindi noted that another ingredient that has gained popularity is UC-II Natural Collagen Concentrate.

Natreon’s AyuFlex is a vegetarian, organic, non-GMO (genetically modified organism) joint product developed from the ayurvedic ingredient Terminalia bellerica, which is an edible fruit. One study done in moderately osteoarthritic subjects has shown that supplementation with AyuFlex resulted in significant improvements in WOMAC scores, knee-swelling index, and VAS (for pain, stiffness, and disability) compared to placebo. Two additional pain studies showed that single dose administration of 1,000 mg of AyuFlex resulted in significant improvements in pain tolerance. This is a safe, efficacious and vegetarian alternative to glucosamine/chondroitin and UC-II.

Another ingredient with a history of use in Chinese and ayurvedic medicines, is from Andrographis paniculata, an annual herbaceous plant. Although HP Ingredients has been providing their version, Paractin, for a few years, its sales team has witnessed increasing sales and inquiries about its use in joint health supplements, said Eng. “This may be a reflection of increased media exposure about the role of inflammation in joint discomforts.”

Paractin is a patented extract of Andrographis paniculata, standardized to andrographolide, 14-deoxyandrographolide, and neoandrographolide. (U.S. Patent No: 8,084,495 B2). Preliminary research has shown ParActin to promote healthy inflammatory response by naturally inhibiting NF-kappaB, the key regulator of our inflammatory response system, thereby naturally reducing pro-inflammatory cytokines and proteins associated with pain and redness from everyday activities.

“Claims our brand marketing partners may use for Paractin are: ‘Supports healthy inflammatory response,’ ‘Supports healthy joint function,’ and ‘Supports healthy bone structure,’” Eng added.

Category Trends

Answering the trending demands for natural and organic vegan ingredients, HORN offers ErgoMax, which is a vegan vitamin D2 derived from conventional and organic mushrooms. Another ingredient that answers to trends in this category is Nutri-K, offering the most bioavailable form of vitamin K2 derived from fermented natto soy beans. Nutri-K is made in Japan and has 99 percent of the active trans form of menaquinone-7, noted Chien.

Lund added that collagen is gaining ground beyond skin health. “It is widely recognized as a strong supplement for joint health and with our research, KoACT, a patented combination of collagen and calcium, is proven effective for bone health.” kollaGen II-xs supplies the body with more hyaluronic acid than any collagen products on the market, Lund explained, adding that it is an important nutrient for joint health, eye health and skin health, as well as offering more chondroitin, an important nutrient for joint and cell health.

The company’s kollaGen II-xs is denatured type II collagen processed by using an exclusive water extraction technology process without using solvent (ethanol) to change the original molecules for assimilation and is recognized as a nutrient as building blocks for damaged cartilage. The category’s inclusion of more vegetarian and herbal ingredients has seen a rise in turmeric, boswellia, and Terminalia chebula (unlike glucosamine/chondroitin and UC-II), said Kalidindi. Natreon’s AyuFlex (Terminalia chebula) is a vegetarian, organic, non-GMO ingredient for joint health.

Ultimately, noted Davis, bone and joint health are among top concerns for consumers, and they believe supplements can help. “Joint and bone supplements rank in the top 10 in health benefit believability for statements like ‘promotes healthier and stronger bones’, ‘helps to maintain bone, joint and muscle function with aging’ and promotes healthier and more flexible joints’ (HealthFocus 2012),” she said. “This type of reaction helps drive product launches and product sales. It is interesting to note, however, that despite a constant increase in product launches over the last decade, the number of patent applications and scientific publications have leveled off in the last few years. This points to a need for innovative, new ingredients with proven efficacy in the joint and bone space.”

Delivery Innovation

Supplements are by far the leading application for joint health ingredients. At the same time, suppliers said they see a good deal of interest in the development of beverage-based, gummies and other delivery forms.

“To meet the required 1 g of calcium daily intake, any tablets that meet such requirement would be a horse pill,” noted Chien, adding that sachet, effervescent tablets, and ready-to-drink beverages are more suitable delivery forms compared to pills. Another option is HORN BlastMax, a new delivery system that stores active ingredients in a universal bottle cap. When in need, the consumer just places the HORN BlastMax cap on a water bottle, blast the ingredients into the water with a push of a button and enjoy the drink instantly. The HORN BlastMax technology can increase the shelf life of the actives. It can also reduce the use for fillers and excipients.

“Delivery innovation in this category includes development of liquid and soft gel formulations, which can increase patient compliance,” added Kalidindi, who said that powder delivery system for both drinks and food is also becoming more popular. Natreon’s AyuFlex can be compressed into a small tablet, capsule or caplet compared to the large tablet size of glucosamine and chondroitin, she said.

Addressing Category Hurdles

Despite reports of high intakes of calcium being associated with a higher risk of cardiovascular disease in women, “calcium is good for bones, period,” said Chien. “However, like every other nutrient, calcium has to be utilized properly in the body for it to be beneficial for bone health. In the case of calcium, it needs help from vitamin K2, which plays a key role in metabolizing calcium. Vitamin K2 will remove excess calcium from the arteries and deposit into the skeleton. Better formulation is the key to overcome the calcium controversy. In addition to vitamin K2, magnesium, phosphorus, vitamin D and boron can be beneficial bone nutrients.”

Partnering with a seasoned ingredients distributor like HORN helps finished product marketers gain confidence in working with high-quality, efficacious ingredients backed with formulation experts who offer reliable technical support, she added.

Another issue in this category relates to the allowable language that can be used to discuss the actions and benefits of dietary supplements, noted Halpern. “Certainly it is well understood that disease claims are not allowed when marketing supplements, so references to osteoporosis and other overt diseases associated with bones and joints must be avoided. However, more subtle claims involving topics such as inflammation are also being called into question. FDA’s (U.S. Food and Drug Administration) position that inflammation is closely tied to disease processes and therefore most often constitutes a disease claim presents challenges when trying to communicate the attributes and science that support various ingredients and products. The challenge the industry faces is continuing to find ways to clearly communicate how and why a product works while maintaining regulatory compliance.“

The National Institute on Aging calls osteoporosis the “bone thief,” and rebuilding strong bones is the obvious challenge. Lund pointed to a study done on AIDP’s KoACT product. “It’s important to understand the bone remodeling cycle. Every day, old bone is broken down by cells called osteoclasts in a process known as bone resorption. Meanwhile, new bone is built by cells called osteoblasts in a process called bone ossification. At a young age, ossification outpaces resorption, giving bones strength and flexibility. But as the body ages, the opposite occurs, making bones fragile and rigid.”

Dr. Bahram H. Arjmandi at Florida State University conducted the randomized, double-blind, placebo-controlled human clinical trial and found KoACT caused a significant increase in total body bone mineral density among post-menopausal women compared to the same amount of calcium after just three months. It also increased biomarkers of bone synthesis.

“Post-menopausal women should be losing 3-5 percent of their bone mass each year, and in this study, that was the case. Women taking a calcium/vitamin D supplement lost more than one percent of their bone after three months,” said Arjmandi. “But the amazing news is, the women who took KoACT not only did not lose bone mass, but rather, they rebuilt bone. That is pretty difficult to achieve.”

Other Research PLT Health Solutions markets two boswellic acid extracts, 5-LOXIN and AprèsFlex. Both ingredients have been demonstrated to inhibit 5-lipoxygenase and MMP-3 enzymes, thereby supporting healthy joints and connective tissue.

In a recent human study, both 100 mg and 250 mg of 5-LOXIN daily provided improvements in joint comfort and mobility within seven days. Daily consumption provided significant benefits in WOMAC, VAS and LFI standardized testing methodologies for joint health and positively impacted biological markers associated with joint and general health, including TNFa, CRP, and IL-6. 5-LOXIN was also shown to significantly inhibit matrix metalloproteinase (MMP-3), enzymes that break down cartilage, collagen and connective tissues.

According to the company, AprèsFlex is the next generation boswellia extract composition based upon the clinically studied Boswellia serrata extract providing acetyl-11-keto- ß-boswellic acid (AKBA). With this composition, ApresFlex provides improved bioavailability and bioactivity of the AKBA. ApresFlex has been clinically evaluated in three studies, two of which are published, showing joint health benefits in as early as five days from 100 mg.

“Similar to other areas of health, a growing area of research in the bone and joint category is investigating the ability of ingredients and products to show a benefit in people who do not have overt disease,” said Halpner. “Populations such as older adults who may have normal age-related wear and tear and bone and joint complaints, but an absence of clear disease are becoming an intriguing target of research. Can we maintain bone and joint health in these individuals as they get older? Can we show a benefit of supplementation in a disease-free population? Positive results in this type of research will lead to further growth in this category as well as increased interest in the overall usefulness of supplementation in general.” NIE

For More Information:
AiDP, Inc., (626) 964-6910
Douglas Laboratories, (800) 245-4440
HORN Nutraceuticals, (800) 442-4676
HP Ingredients, (877) 437-2234
NattoPharma USA, (609) 454-2992
Natreon Inc., (732) 296-1080
PLT Health Solutions, (973) 984-0900

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