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A Well-oiled BMJ Machine

CapsCanada
 
K2VITAL®
BMJ Health BMJ Health

Bone, muscle and joint (BMJ) issues look to disrupt the body, but the latest ingredient innovations look to do otherwise.

You may have heard it many times before, but the human body is a well-oiled machine. Of course, that is what it should be.

From a general perspective, proper body maintenance is easier said than done. It is no secret that the organs must work in unison for ideal living—even exteriorly, the body has to deal with the combination of constant wear-and-tear and long-term effects of damage to one’s bones, muscles and joints.

One particular condition that comes to mind regarding the joints is arthritis. According to the Arthritis Foundation, it is the leading cause of disability among U.S. adults—the foundation estimates that approximately 54 million adults have arthritis that has been diagnosed by a doctor.

More so, by the year 2040, this amount is expected to jump to 78.4 million, making it more than 25 percent of all adults in the country.

There is no doubt that tackling bone, muscle and joint health sits high atop ingredients suppliers’ and manufacturers’ priority list—innovation and research has helped this field continue to strengthen over the years.

Trending Ingredients

The bone-muscle-joint category has a variety of usual players, starting with collagen.

According to Vincent Hackel, CEO of California-based Guzen Development, which offers SCP-II (salmon collagen proteoglycan complex), undenatured proteoglycan is beginning to catch fire. It is already being used in Japan and is anticipated to emerge in the U.S. alongside side undenatured type II collagen.

“Collagen is considered one of the most versatile and important ingredients in modern health & nutrition markets—including in functional foods,” said Heather Arment, marketing coordinator (North America), GELITA, who has a local location in Iowa. “So, while collagen has been successfully used for years in topical beauty and personal care products such as body lotions, face cream and more, recent scientific evidence confirms that the highest efficacy can be achieved when collagen is ingested orally. And, GELITA’s Collagen Peptides are highly versatile. With their special nutritional and technological properties, these pure proteins are enjoying increasing popularity throughout the beverage, food and health and nutrition industries—not only because they can be easily incorporated into various types of applications, but too, because they are non-allergenic and free from additives, carbohydrates, cholesterol, fat, gluten and sugar—and, they are neutral in odor and taste. In their natural form, they do not react with other ingredients; therefore, they can enhance and optimize the most diverse applications, from liquids to solids.”

Calcium has also been a popular choice, but additional vitamins and minerals play essential roles, especially for sports nutrition.

“Calcium has long been the mainstay for bone health supplements,” noted Nena Dockery, technical services manager with Missouri-based Stratum Nutrition, “but these supplements rarely contain just calcium. These supplements usually also contain vitamin D3 and magnesium, but more supplements now additionally contain other beneficial nutrients such as vitamin C, vitamin K2, manganese and even boron. Supplements for muscle health usually center around muscle recovery following exercise or supplements to improve endurance. Protein-based shakes and other beverage formats are common in this category. Sometimes these contain additional amounts of certain amino acids, such as L-arginine or glutamine, as well as other nutrients like CoQ10 or an immune system-supporting vitamin/mineral blend.”

Dockery added that Stratum’s NEM (branded eggshell membrane) can significantly reduce pain and stiffness within seven to 10 days for people who suffer from daily discomfort and stiffness, or even those individuals who need that extra joint support when enduring a new workout, helping to reduce biomarkers of cartilage breakdown.

She was also in agreement with Arment in regard to collagen, but stressed the importance of other options that can help combat inflammation as well. “Within the last decade, the predominant ingredients in joint health products have changed,” Dockery said. “This category used to be dominated by glucosamine sulfate and hydrochloride and chondroitin sulfate. Their popularity has driven them into the commodity realm of ingredients, and quality has suffered as a result. Arising out of this market flux has been an increase in the popularity of several other ingredients including those that are part of the joint structure, such as collagen, and ingredients that have been studied for general health benefits, including those studied for their benefits in supporting a healthy inflammatory response, such as curcumin and Boswellia serrata.”

California-based AIDP offers its patented collagen, KoAct. “ … AIDP’s KoAct is a patented combination of collagen and calcium, that is clinically proven superior to traditional bone health ingredients in improving bone mineral density,” explained Samantha Ford, the company’s business development director. “K2 is also a strong bone health alternative, as it aids calcium in reaching the bone mass and incorporating calcium then into the bone, where it is needed for bone building and strengthening. Furthermore, it ensures calcium is not deposited in the arteries, where it can build up and cause serious cardiovascular risk.”

Ford also added that as alternative delivery applications continue to grow in popularity, AIDP is working with manufacturers to help develop solutions including flavor masking and instantizing.

While these well-known supplements/ ingredients have gained stardom throughout the years, some manufacturers may not be aware of the fact that sales may have struggled slightly for some of the ingredients in the bone, muscle and joint category.

“Calcium, multivitamins, vitamin D and magnesium are the most popular bone and joint supplements, according to data from NBJ 2018. Other than vitamin D, sales for these single ingredient supplements have been stagnant or dropped since 2007,” Bruce Brown, MPH, MA, president of New Jersey-based Natreon pointed out. “Historically, consumers have relied on single ingredient supplements such as calcium, but recent clinical studies have turned their attention to more innovative ingredients. Scientific data has proven to be the driving force in consumer sales as well as evolving demand for natural and botanical supplements.”

The challenge lies in being able to reach a much more general audience, as Brown added that “manufacturers are seeking ways to communicate novel benefits to a broad demographic profile. Thus they seek ingredient combinations that deliver on the evolving need of the consumer. In many cases, the new focus is on Non-GMO (genetically modified organism) Project Verified, organic, and most importantly clinically proven. Natreon’s ingredients deliver on these attributes.”

In fact, David O’Leary, commercial manager for Marigot Ltd. in Ireland, producer of Aquamin (marine multi-minerals), broke down the major manufacturer concerns into five succinct categories:

1.Safety: Are the products or bioactive compounds being considered seen as safe and is there sufficient evidence to prove this?

2. How have the products in question been considered for the end consumer? Have they been shown to be efficacious for bone and or joint health (osteoporosis/osteopaenia/osteoarthritis)?

3. Science: What level of supporting research is there? Has it been published and is this evidence-based research safe and reliable?

4. Origin: Is it natural? Cleanly obtained? Non-solvent vs. Water-based?

5. Sustainable: Is it responsible to the source and environment?

Additionally, manufacturers face the tall task of addressing these concerns while also remaining innovatively relevant in 2019.

Innovation

As previously noted, collagen is beneficial in more ways that one, making it a supplement that has been on the rise; in fact, Natreon’s branded form of shilajit has shown its share of potential, especially since it can go hand-in-hand with collagen.

“The bone, muscle and joint category has seen an impressive growth in innovation from delivery forms, to personal tracking apps, to novel ingredients based on clinical studies,” Brown observed. “One of these ingredients has redefined the category and driven growth, collagen. Collagen improves bone mineral density, muscle growth and joint health, making it the new most popular supplement for BMJ health. Supplementing with collagen peptides has proven effective, but they aren’t vegetarian. Recently, we have seen innovation in ingredient offerings that provide non-animal options for consumers seeking improved BMJ health. One such ingredient is PrimaVie shilajit, which in recent studies conducted at University of Nebraska-Lincoln and Ohio State University found PrimaVie supports the body’s natural collagen synthesis by upregulating the genes responsible for collagen synthesis. Furthermore, this novel ingredient for BMJ health was found to reduce hydroxyproline, a biomarker of collagen breakdown. PrimaVie is a vegan option for those seeking non-animal sources to support bone muscle and joint health or for those looking to enhance the health benefits of collagen supplementation. This is an exciting ingredient addition to a category as consumers seek advances in innovation in the bone muscle and joint category.”

Arment seconded Brown’s collagen sentiments—the ingredient is multi-faceted in the sense that it can be used in a plethora of delivery systems. “Collagen-based beverages, foods and supplements continually innovate,” she noted. “Recently, there have been launches of collagen-based gummies and chews. These convenient, portable supplements offer all the benefits of collagen in a fun and indulgent delivery system. Beverages are a convenient delivery system for important nutrients and supplements, especially collagen, whether ready-to-drink or powders, beverage applications are innovating by offering unique flavor profiles and exciting texture sensations. And, as collagen is a food in/of itself, its use in food is expected. In the nutritional bar category, collagen lends itself well. Again, in this category we are seeing bars offering exciting and worldly flavors, along with the benefits of collagen protein.”

It is important to keep in mind that the idea of innovation is not always as straightforward as it may seem. One must be knowledgeable of where market trends stand at a particular point in time, along with being prepared to make adjustments if necessary. Curcumin, for instance, has helped to lead by example.

“Companies that are interested in keeping up with the pace of changes within the supplement industry use innovation to keep their ingredients and formulations fresh and new,” said Dockery. “Innovation doesn’t simply mean adding in small amounts of the current fad ingredient, but looking at changes in market trends regarding dosing formats or ways to show sustainability of the ingredient or perhaps going through the process of making the ingredient non-GMO or organic.

“In recent years, there has been a substantial amount of research devoted to developing innovative ways to improve the absorption of beneficial ingredients, such as curcumin. The clinical efficacy of these ingredients is often limited by poor intestinal absorption and/or rapid metabolism that can reduce their benefits in the body. This innovation has resulted in the introduction of proprietary ingredient forms with improved clinical benefits and lower doses.”

BMJ Market Status

While it is unfortunate that bone and joint pain tends to worsen as a person ages, this fact seems to be be a positive detail for this category’s market. “As our population ages and our lifespans increase, the need for bone and joint support products should continue to grow, especially as with the desire to stay active later in life,” said Patrick Stano, senior brand manager with California-based Stauber Performance Ingredients, the exclusive distributor for Marigot in both the U.S. and Canada.

Ford was in agreement, also noting that the growth of the bone market will be propelled by the popularity of bone both products and functional foods.

She is even interested to see how collagen products will continue to develop, saying they have “grown substantially in recent years. Full-spectrum collagens are the next big thing—those that provide collagens type I through X.”

Interestingly enough, hip fractures are more prevalent than many may believe, which further demonstrates how much of an impact BMJ health plays. “Ailments affecting the bone, muscles and joints are widespread, and their occurrence increases as people age,” explained Anne Trias, MS, product director with Massachusetts-based American River Nutrition. “For osteoporosis, for example, the worldwide incidence of hip fracture is projected to increase by 310 percent in men and 240 percent in women by 2050, as reported by the International Osteoporosis Foundation. … Arthritis is thought to increase as the population grows and ages, with ~50 percent of cases occurring in people age 65 and older.

“These trends, coupled with our growing aging population and lack of therapeutic options in mainstream medicine, suggest a tremendous market potential for alternatives such as dietary supplements. Well-known ingredients with strong science backgrounds, including collagen, vitamins K and D, and more recently tocotrienols, are bound to do well in this category. These ingredients have shown remarkable benefits without the downsides that are often experienced with traditional medicine. For those suffering from osteoporosis, for example, available drugs that slow bone loss can have serious side effects, such as bisphosphonate-related osteonecrosis of the jaw. Moreover, treatment options for osteoarthritis are limited to pain relief, use of supportive devices, weight loss and steroids. None of these ‘standard protocols’ remedy the condition.”

Interest in Research

Marigot’s research focus begins with proof of transparency—clean label is vital, followed by ingredient effectiveness, which Aquamin has demonstrated via human studies.

“[We are looking for] evidence of efficacy highlighting benefits of products in the chosen categories: osteopaenia avoidance, maintaining healthy bone density especially in female categories post menopause. Improved bioactivity and bioavailability are also key, as more and more consumers become educated for their own health issues,” O’Leary explained. “Natural origin, science-based ingredients that are clean label and proven are also very much on-trend.

“Our products [at] Aquamin come with a significant amount of science-based research across bone and joint health,” he continued. “Comparative human studies involving our material tested against other calcium salt forms have been carried out and shown unique efficacy over other mineral forms. In the joint health sector, we have looked at comparative studies against widely used joint health products such as glucosamine sulfate. Again, our human study evidence suggests that our all-natural unique multi-mineral matrix is more effective at relieving symptoms associated with osteoarthritis—and positively influencing pain, stiffness and improving mobility.”

Natreon is continuously seeking results as they relate to the various branded ingredients that the company offers, including Sensoril, PrimaVie and more.

“Natreon continues to focus on clinically proven health benefits with our portfolio of ingredients,” Brown said. “The BMJ category is seeking innovation as consumers move away from standard synthetic products that have dominated the industry to natural products that have proven science. Primarily, adaptogens along with collagen have driven growth in the category and have appealed to consumers. Natreon has completed or has in progress over 10 clinical studies with outcomes measures in the BMJ category. Our adaptogens Sensoril ashwagandha and PrimaVie shilajit have recently concluded U.S. studies that show positive results. These two adaptogens coupled with our AyuFlex ingredient, are our lead ingredient candidates in the category.”

Besides aging, American River Nutrition considers other details, including weight and metabolic syndrome, among others. It has various studies utilizing its DeltaGold ingredient, its branded form of tocotrienol.

“A variety of factors have been linked with bone and joint health, including aging, obesity and metabolic syndrome, oxidative stress and inflammation,” Trias mentioned. “These are some of the primary endpoints we are now looking at when designing clinical trials. With our DeltaGold tocotrienol ingredient, for example, we looked at a population of post-menopausal women with osteopenia, and although we mainly focused on bone turnover biomarkers, we also examined the level of oxidative stress.1 Not surprisingly, the annatto-derived vitamin E tocotrienol—a potent antioxidant—significantly reduced urine 8-hydroxy-2’-deoxyguanosine (8-OHdG), a stable and reliable oxidative stress biomarker of DNA breakdown product, by 49 percent. It may be in part due to tocotrienol’s antioxidant mechanism that we saw the significant improvements in bone remodeling (~100 percent) along with decreased bone resorption (13-24 percent) after 12 weeks of supplementing daily tocotrienol doses of 300 mg and 600 mg. When possible, as it was in this case, we strive to design our studies to the gold standard, which is randomized, double-blind, placebo-controlled clinical trials. Our collaborators at Texas Tech University, who conducted the study, also published an excellent report concerning the safety of consuming higher doses of tocotrienols for an extended time period: No adverse events were reported by study participants, giving tocotrienol—an FDA (U.S. Food and Drug Administration) GRAS (generally recognized as safe) ingredient—a stellar safety assessment.2 Considering that obesity and metabolic syndrome have been strongly linked with bone loss and because of our prior clinical success with tocotrienols in bone health, the same researchers have designed a second trial in obese post-menopausal women, which will run for 24 weeks. DeltaGold tocotrienols will be used at 300 mg/day.”

As more educational materials become accessible, consumers are seeking more substantiation to support product claims, which is where research comes into play. This holds true, even in the professional arena.

“With today’s consumers being better educated on the correlation between health and nutrition, Arment explained, “they are also becoming more interested in understanding how these products work in collaboration with one another. This means consumers will favor products with the greatest amount of scientific research and substantiation to support them. Scientific proof is paramount for active ingredients within the BMJ space. Here, successful ingredient companies will offer a collection of high-level, peer reviewed clinical studies that illustrate an ingredient‘s efficacy. Gone are the days of relying on anecdotal evidence. Fact-based clinical research is the basis for structure-function claims and consumer confidence.

“Even the International Olympic Committee (IOC) is recognizing that collagen supplementation might be beneficial for the athletes. In their recently published consensus statement, they concluded that ‘Collagen may support athletes to train harder and perform better.’ And, their findings are based on research primarily conducted with GELITA Bioactive Collagen Peptides.”

A point to consider is research in healthy subjects—achieving results in this environment is a challenge on its own. “Within the supplement industry, there is greater emphasis now in conducting research in healthy populations,” Dockery explained. “This has always been the requirement from the FDA, in order to distinguish supplement ingredient research from that for pharmaceuticals. However, achieving meaningful results in subjects who are already healthy is difficult—how do you improve on a health status that is already good? This is made even more difficult because the FDA also stipulates that, except for a select few qualified health claims and claims for deficiency disease prevention through supplementation of specific vitamins or minerals, prevention claims are disallowed. Therefore, some researchers use exercise as a means of stressing the body and then determine the beneficial effects of dietary supplement ingredients on the rate or degree of recovery from exercise-induced joint pain and/or swelling.

“ … The joint health ingredient, NEM brand eggshell membrane has already been the focus of one published healthy person trial,3 and a second study has just concluded. These trials used exercise as a means of stressing the joints in the hips, knees and ankles. These healthy person trials also employed the use of an objective measurement tool in addition to more subjective tools such as questionnaires for assessing pain and stiffness. Reduction in the levels of the cartilage degradation biomarker, CTX-II (C-terminal cross-linked telopeptide of type-II collagen) was used to demonstrate the cartilage protection capability of NEM.” NIE

References:

1 Shen CL, Yang S, Tomison MD, Romero AW, Felton CK, Mo H. Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial. Osteoporos Int. 2018. Epub 2018/01/14.

2 Shen CL, Wang S, Yang S, Tomison MD, Abbasi M, Hao L, et al. A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity and nutrient intake. BMC Complementary and Alternative Medicine. 2018;18(1):198. Epub 2018/06/30.

3 Clin Interv Aging (2018) 13:285-295.

For More Information:

AIDP, www.aidp.com
American River Nutrition, www.americanrivernutrition.com
GELITA, www.gelita.com
Guzen Development, www.guzendevelopment.com
Marigot, Ltd., www.aquamin.com
Natreon, Inc., www.natreoninc.com
Stauber Performance Ingredients, www.stauberusa.com
Stratum Nutrition, www.stratumnutrition.com

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