Boning Up on Joint Care Ingredients

If recent newspaper headlines are any indication, there are good days ahead for bone and joint support products.

In September, Merck (Whitehouse Station, NJ) withdrew its much-publicized Vioxx arthritis and pain drug amid reports of increased heart attack and stroke risks, leaving a natural void for supplement makers. And in October, the U.S. surgeon general’s office issued its first-ever report on bone health, launching a national effort to urge consumers to take action to improve and maintain healthy bones. “Everyone has a role to play in improving bone health, and this report is a starting point for national action on bone health,” declared U.S. Surgeon General Richard Carmona, MD.

Of course, the fact that growing numbers of aging baby boomers are ripe for such age-related ailments as osteoarthritis and osteoporosis has not escaped notice. “I expect the joint and bone support market to continue to grow,” says Wayne McCune, vice president of sales and marketing, Cardinal Nutrition (Vancouver, WA). “It may ultimately double by the year 2030, due primarily to the active but aging baby boomer population. We also have more informed consumers today who take a much more active role in managing their own healthcare. Many of them are looking for alternatives to pharmaceutical products like Vioxx, and this helps drive the demand for joint health supplements.”

GLUCOSAMINE AND CHONDROITIN SURGE AHEAD

With total annual sales estimated at $600 million to $700 million, the combination of glucosamine and chondroitin is the hottest ticket in town among joint and bone support products.

“The awareness of chondroitin and glucosamine continues to grow, not only in dietary supplements but in other food and beverage categories,” says Lee Knudson, product line manager at Cargill Inc. (Wayzata, MN), adding that the combination benefits from ongoing studies and the sound science behind it.

In fact, glucosamine and chondroitin’s reputation for efficacy attracted the attention of the National Institutes of Health (Bethesda, MD), which is scheduled to complete a five-year clinical trial on their effectiveness in November 2005. Designed to determine whether glucosamine, chondroitin sulfate, and/or the two combined are more effective than a placebo in treating osteoarthritis pain, the multicenter GAIT study (Glucosamine/Chondroitin Arthritis Intervention Trial) enrolled nearly 1600 patients nationally.

“When it wraps up in 2005, GAIT is going to affect the industry profoundly,” says Erik Paus, director of Seikagaku America (East Falmouth, MA). “I think FDA will step into the nutraceutical market a little bit stronger.” Paus thinks it will be forced to if research shows that glucosamine and chondroitin now have a pharmacological effect. “FDA will start to demand traceability, lot history files, etc., from manufacturers,” he says. “That may cause a bit of a shakeup for some of the current suppliers if they have to conform to more rigorous inspection.”

“I’m hopeful that will happen,” adds Paus. “It will legitimize the entire nutraceutical market in many people’s eyes.”

CALCIUM CONNECTIONS

The emphasis on calcium consumption in the recent surgeon general’s report is likely to boost the popularity of a mineral that already enjoys a strong association with bone health, say industry experts. And calcium is a major player in the supplement market, with annual sales estimated at more than $800 million by industry sources.

“The future is bright for calcium,” says Bassam Faress, director of sales and marketing at Garuda International Inc. (Lemon Cove, CA). “Many people look at calcium as a good source of nutrition for preventing bone loss disease, and there’s been a lot more interest in milk sources of calcium over calcium carbonate and other forms that are not as bioavailable.”

Loren Ward, associate director of research for Glanbia Nutritionals (Twin Falls, ID), agrees that calcium ingredients from milk offer specific advantages for bone health support.“Recent research indicates that it may be beneficial to take more than just calcium if you are concerned about bone health,” says Ward. “For example, bones are made up of several macrominerals, such as calcium, magnesium, phosphorus, potassium, and several microminerals, such as copper and zinc. Milk contains the essential macro- and microminerals needed to build healthy bones, and isolating the minerals provides an excellent mineral ingredient for calcium fortification.”

A product that combines calcium with strong joint health ingredients such as glucosamine or chondroitin also offers good potential in the supplement market, says Faress. “The joint health market has been shifting from osteoporosis to osteoarthritis,” he adds. Faress thinks this is a good chance to combine glucosamine and chondroitin with calcium. “These ingredients have held their own in the industry,” he says.

MSM IN THE MIX

After glucosamine and chondroitin, the next-biggest ingredient for joint health is MSM (methylsulfonylmethane), a compound that is 34% sulfur, which is contained in joint cartilage. After its debut in the market in the 1990s, MSM has increasingly been combined with glucosamine and chondroitin and other joint support ingredients, a trend that is likely to continue, suggests Wayne McCune of Cardinal Nutrition, which pioneered MSM production for supplements in 1989.“Every successful ingredient tends to be offered in more forms over time, so we expect to see MSM available in more new products,” says McCune. “We believe our trademarked form, OptiMSM, has untapped potential in joint health and perhaps even in other body functions such as heart health.”

MICROLACTIN MAKES INROADS

Another ingredient gaining prominence is the milk protein MicroLactin. “We’ve been in the market for about three years, but in the last 12 months MicroLactin has really taken off,” says Scott Steil, executive director of sales and marketing for Humanetics Corp. (Eden Prairie, MN), which markets MicroLactin concentrated milk protein for joint health. “The crown jewel helping push MicroLactin is FluidJoint, sold by PatentHealth. In the drug channel where FluidJoint was launched, it has become the best-selling branded SKU in the entire joint-care category.”

Steil says MicroLactin’s mechanism of action is unique in the joint health industry: MicroLactin works by inhibiting the migration of neutrophils to sore joint space, which quickly helps reduce both pain and inflammation. “The onset of action among MicroLactin products is phenomenal,” Steil says. “People get very solid relief in a week, based on anecdotal feedback, and there’s improved joint health in as little as two weeks, based on published clinical trials.”

BOOSTING CALCIUM ABSORPTION

Calcium is well documented as a building block for healthy bones. So increasing the mineral’s absorption rate offers even bigger potential benefits, especially for adolescent girls and postmenopausal women.

“Many of our customers are starting to look at making label claims on calcium absorption,” says Hilary Hursh, a food and nutrition scientist with Orafti Active Food Ingredients (Malvern, PA), which markets the enriched inulin ingredient Raftilose Synergy1. “And we do have some customers already making the label claim with Synergy1.”

In fact, the company recently released the results of a new study suggesting that Synergy1 could boost postmenopausal women’s absorption of calcium by 20%, Hursh says. The study also suggests that Synergy1 has a positive effect on periods of bone-mass loss and bone-mass development.

The new Orafti research backs up earlier studies showing similar effects on mineral absorption among adolescent girls, says Hursh.

In addition to new MicroLactin-based products such as Nature’s Bounty’s Vital Joint, launched by NBTY (Bohemia, NY) in June, the milk protein concentrate is turning up in supplements that incorporate several different joint health ingredients. Construction Zone with MicroLactin, rolled out in May by Bio-Kinetics Corp. (Sioux Center, IA), combines MicroLactin with chicken-derived chondroitin, glucosamine, and microminerals.

Looking to the future, says Steil, “Humanetics has partnered with a leading contract manufacturer to produce tablets with MicroLactin and glucosamine, and MicroLactin plus hyaluronic acid. They’re not commercially sold at this time, but we do have several companies that are interested in such a combination product.”

COLLAGEN AND HYALURONIC ACID

Among the 14 different types of collagen found in the body, type II collagen is the main structural protein in cartilage. Hyaluronic acid (HA), an emerging joint health ingredient, is one of the substances interwoven in type II collagen matrixes. It’s also an integral part of BioCell Technology’s (Anaheim, CA) BioCell Collagen II-a naturally occurring matrix of bioavailable hyaluronic acid, chondroitin sulfate, and type II collagen-whose efficacy is supported by newly released research.

BioCell Technology recently announced the results of a double-blind clinical trial showing that BioCell Collagen II is safe and effective in helping to alleviate pain associated with osteoarthritis. The study, published in the Federation of American Societies for Experimental Biology Journal, involved 16 male and female subjects who took 1000 mg a day of BioCell Collagen II.

Research released early last year also suggested that BioCell’s reduced-molecular-weight HA has significant peak absorption and steady-state bioavailability in normal volunteer subjects.“A lot of the hyaluronic acid on the market right now is purified form, which is high molecular weight,” says Suhail Ishaq, vice president of BioCell Technology. “Some studies show that that material is not absorbed-it was developed to be used in cosmetics, not for oral use.”

THE PUSH FOR RESEARCH

Another recent joint health entry, SierraSil from Sierra Mountain Minerals Inc. (Vancouver, BC, Canada), is also touting new research, suggesting that its product suppresses cartilage degradation and inflammation. Conducted with researchers at Case Western Reserve University School of Medicine (Cleveland), the SierraSil study was published in the Journal of the American Nutraceutical Association (JANA) last fall.

“These results indicate that SierraSil and SierraSil with Vincaria are likely to be effective antiinflammatory agents in the treatment of joint pain and that these benefits are likely due to suppression of gene expression,” says Mark Miller, a professor of cardiovascular sciences and pediatrics at Albany Medical College (Albany, NY), who was the study’s lead researcher.

In Europe, Bioiberica (Barcelona, Spain) has released promising results from two unpublished Spanish university studies on its Hyal-Joint product, demonstrating the compound’s chondroprotective properties and confirming its ability to be absorbed in the intestine. Hyal-Joint is a natural extract with sodium hyaluronate, which nourishes synovial fluid, a vital joint component that facilitates and cushions movement.

Research efforts like this are the wave of the future for the joint health industry, says Michael Bentley, executive vice president of Sierra Mountain Minerals.

“There are a lot of products on the shelf that don’t have firsthand clinical research-the organizations use second- or third-hand research on one or two of their ingredients,” Bentley says. “What’s interesting is that more people in the industry are waking up to the importance of firsthand clinical research. There’s an education curve with any industry, a natural education process.”

“The industry is going to demand better substantiation of claims-in other words, stronger scientific background-not only for ingredients but for formulations as well,” agrees Cardinal Nutrition’s McCune.

Communicating these claims to consumers, however, is likely to remain one of the joint health industry’s challenges, says Bentley. “For example, we can’t post our JANA study on our Web site because that study suggests that SierraSil is effective for the treatment of certain conditions, and we’re not allowed to make that claim to consumers.”

But ultimately, Bentley hopes, companies that market bone and joint support products will find it easier to make consumers aware of their documented claims. “The good companies in this business-and there are many-need to find ways to differentiate themselves from companies that sell products with claims that are often unsubstantiated by real research.”