Presented By: Ram Chaudhari, Ph.D., FACN, CNS Sr.

Executive Vice President, Chief Scientific Officer

PAGE

Strategic Nutrition for Bone and Joint Health Nearly eclipsed in the public eye by health conditions with more visibility, bone and joint conditions are in fact the leading cause of long-term pain and physical disability worldwide. The range of musculoskeletal conditions includes, back pain, osteoporosis, rheumatoid arthritis, osteoarthritis and bodily injuries. All together, they place an enormous burden on society, including the personal suffering of those afflicted, as well as the cost of lost productivity, lost wages, and treatment. Osteoporosis is a bone disorder primarily seen in the elderly, especially in women, and is currently estimated to affect 44 million people in the US, alone. This chronic disease results in loss of bone mineral from the skeleton, which weakens the bone and leads to an increased risk of bone fracture. Osteoarthritis is a joint disease that mostly affects cartilage, which is a slippery tissue that covers the ends of bones in a joint. Cartilage acts as a shock absorber and allows the bones to glide over each other. When the cartilage breaks down and wears away, the bones under the cartilage rub together. This rubbing of bone on bone causes pain, swelling, and loss of motion of the joint. Osteoarthritis is the most common joint disease and currently affects 34 million people in the US, and although it can occur in younger people following joint injuries, like osteoporosis, osteoarthritis is most often seen in the elderly, as illustrated by hand, knee and hip osteoarthritis incidence data from the US in Figure 1.

Issues surrounding bone and joint health can impact both young and old

From Oliveria SA, Felson DT, Reed JI, et al. Arthritis Rheum. 1995;38:1134-1141.

Figure 1. Osteoarthritis incidence in the United States by age group.

Osteoarthritis is a localized disease affecting only bone joints, and in addition to aging, obesity is an important risk factor for the development of osteoarthritis. Another common form of arthritis is called rheumatoid arthritis. Rheumatoid arthritis also affects the joints, but it is a systemic disease, possibly caused by an auto-immune reaction or genetic factors. Rheumatoid arthritis can manifest itself in non-joint-related symptoms, including general fatigue and flu-like symptoms. Affecting 1.3 million people in the US, it occurs most frequently (70% of the cases) in women, aged 30-50 years. However, when it occurs in men, it tends to be more severe; and children can be affected as well. Important to all of these chronic diseases are early diagnosis and effective treatment to reduce excess bone loss and joint disability. In this regard, a number of essential nutrients and other functional ingredients have been shown to be important in managing these conditions.

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 2

2 0 1 0

PAGE

Global Perspective Aging and obesity are important factors contributing to bone and joint disorders. Given the rising numbers of older and obese people in both economically developed and less developed countries, bone and joint health is a global concern. The burden of bone and joint disease is so weighty, that governments, NGOs, patient advocacy groups and health organizations around the world started a collaborative initiative dedicating 2000-2012 as the Bone and Joint Decade (BJD). According to the BJD, 50% of chronic disease in the elderly is represented by joint diseases and 40% of women over the age of 50 are expected to suffer a minimum of one osteoporotic fracture within their lifetime. According to the World Health Organization (WHO), osteoporosis ranks second to cardiovascular disease in terms of its global healthcare burden.

Nutritional needs change as we age. Ask the Experts for more info on this by visiting fortitech.com

Worldwide, the US has the most developed bone and joint health market, which is expected to approach $4 billion by 2013. The functional ingredients market that supports bone and joint health is also a billion dollar industry in China and Japan. In Japan, 10 million patients have osteoarthritis, with over 30% of Japanese aged 70 plus, suffering from osteoarthritis, which continues to advance with age. Aging populations worldwide and the long-term consequences of obesity mean an increasing incidence of bone and joint conditions for many years to come. Target Markets Historically, women and adults age 60 plus have been the focus of bone and joint products. The market is growing, as a rising number of men and younger adults are being diagnosed with osteoporosis or are at high risk due to low bone mass according to the National Institute of Aging, two million men in the United States have osteoporosis. A body of information exists supporting that most people around the world do not get enough calcium or vitamin D, and recent research indicates that there is a high percentage of vitamin D deficiency in children under 11, particularly noting deficiency in African American and Hispanic children in the United States. The wide spectrum of deficient populations, in turn, increases the necessity for product innovation and demographic appropriate product development. In some people, evidence of osteoarthritic changes may exist by the second or third decade of life (usually without associated symptoms). By age 40, almost everyone has some osteoarthritic changes in weight-bearing joints (e.g., hip and knee joints) and, by age 75, virtually everyone has changes in at least one joint. Since osteoarthritis is a chronic degenerative disease, this information suggests that even young adults need to consider protecting their joints against chronic wear-and-tear by optimizing their nutrient intakes. Consumer Preferences In the US, consumers are increasingly seeking supplements and functional foods and beverages that promote wellness and have scientific validation. Consumer preference is now turning to foods up 29% and beverages up 11% fortified with joint-health ingredients, according to Nielsen data. According to market analysis by Frost and Sullivan, the prominent competitive factors in the US bone and joint health ingredients market include

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 3

2 0 1 0

PAGE

price, quality, distribution efficiency, ability to provide a point of differentiation through novel ingredient combinations, and value-added services that include assistance in product formulation and regulatory support. Similar analysis abroad shows heightened interest in health promoting foods across much of Europe, in particular. Strategic Ingredients for Bone and Joint Health While calcium was, for years, the most often referenced antidote for bone weakness, in recent years, vitamin D has come to the fore for its own role in promoting musculoskeletal health, as well as for its significant supporting role to calcium in bone health. While products may boast about added calcium on packaging, it needs to be better recognized that calcium works in combination with vitamin D to promote optimal bone health. A significant portion of people worldwide currently do not get an adequate dose of vitamin D through exposure to sunlight and do not take in enough through diet to compensate. Additionally, other nutrients may be minimal or absent from day-to-day diets that may also play a role in achieving optimal musculoskeletal health. Hence, the need exists for a more sweeping nutrient strategy for promoting both healthy bones and joints. In particular, more consumer attention needs to be focused on joint health, and there is a great need to develop new products that target this condition. These products need to provide novel ingredient combinations that promote the maintenance of healthy bones and joints. Below we consider some important ingredients that have been shown to be efficacious in promoting bone and joint health in people. Bone Nutrients By far, calcium and vitamin D have been the mainstay ingredients in bone health-promoting products and the subject of considerable scientific research. However, there is growing consumer interest in other ingredients that could promote optimal bone health. These ingredients shown in Figure 2 include magnesium, vitamin K1 and vitamin K2, vitamin C, and possibly some botanical compounds, such as those found in tea or soy.

There is no one-sizefits-all approach to product formulation for bone and joint health. Nutrients and market forms are unique to each application

Figure 2.

Bone Health Ingredients

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 4

2 0 1 0

PAGE

Calcium Calcium is an important constituent of bone, but is also needed in the body for proper functioning of the heart, muscles, nerves, and in blood clotting. A low intake of calcium, which is common with most people, contributes to bone loss and the development of low bone mass and osteoporosis a skeletal condition affecting 44 million people in the US alone that results in an increased risk of bone fractures, especially of the hip, spine and wrist. Bone loss also contributes to loss of teeth due to erosion of the underlying boney anchor of the tooths root. Tooth loss affects about one-third of adults age 65 and older. Current recommended intakes of calcium are between 1,000-1,300 mg/day depending on age, which is about twice the level of usual calcium intakes. Vitamin D Vitamin D is needed by the body to facilitate the intestinal absorption of calcium, as well as for other important body functions. Unfortunately, vitamin D deficiency is common throughout the world, and contributes to poor bone health, especially when dietary calcium intakes are low. It is estimated that one in five children, aged one to 11 years old dont get enough vitamin D. Prevalence rates for vitamin D insufficiency in black and Hispanic children are, alarmingly, much higher. The current recommended dietary vitamin D intake is 5g to 15g (200-600 IU) per day. However, considerable disagreement over the adequacy of this recommendation has ensued in light of recent research findings, and some prominent vitamin D researchers are suggesting that 50g (2,000 IU) per day may be a more reasonable level of vitamin D intake to promote optimal bone health. Products designed to deliver calcium should also provide vitamin D because these two nutrients work together in order to provide the best opportunity for calcium to be absorbed into the body. Vitamin K Vitamin K is well known for its important role in blood clotting. However, research in recent years has suggested that vitamin K may play an important role in maintaining bone health and reducing the risk of osteoporotic bone fracture in the elderly. Natural vitamin K in the food supply is found in two forms, vitamin K1 (phylloquinone) in plant foods and vitamin K2 (menaquinone) in animal foods or produced by bacteria, with vitamin K1 being slightly more active biologically than vitamin K2. The recommended intakes of vitamin K is 120g/day in men, and slightly lower in women, with intakes as high as 400-500g/day being suggested to influence bone metabolism. However, some very recent clinical trials of vitamin K supplementation in elderly postmenopausal women have found no effect of additional vitamin K on rates of bone loss during a three-year trial. These findings are difficult to interpret, however, because subjects were generally healthy and not selected on the basis of preexisting low vitamin K status. Given the strong epidemiologic evidence that high vitamin K intake is associated with reduced risk of osteoporotic fracture, it would be prudent to include vitamin K as an important nutrient in any bone-protecting fortified product. Vitamin C Higher intakes of fruits and vegetables have been associated with higher bone mineral density in cross-sectional population studies. Investigators in the United Kingdom found that higher vitamin C intake in adolescent boys and girls, young women, and older men and women are associated with bone mineral content. Research in the US found in the Postmenopausal Estrogen/Progestin Intervention Trial (PEPI Study) that higher vitamin C intake

Explore related news and research on bone and joint health on our TweetDeck at www.twitter.com/ fortitech

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 5

2 0 1 0

PAGE

was associated with higher bone mineral density only in women with calcium intakes greater than 500 mg/day. Magnesium Magnesium is a mineral constituent in bone and is important for a variety of other bodily functions, including energy metabolism and proper nerve function. There is scant evidence that adding additional magnesium to the diet will have a positive effect on bone metabolism and no direct evidence that magnesium supplementation will enhance bone mineral density or reduce the risk of osteoporosis. Nevertheless, an intriguing, well-conducted study in eight-14 year old girls found that supplementation with 300 mg magnesium (as magnesium oxide) per day for 12 months resulted in a significant increase in hip bone mineral content compared to a placebo group. An important element of this study was the selection of girls that had relatively low magnesium intakes, less than the RDA of 240 mg/d for this age group. Thus, at least in children, the provision of additional magnesium in the diet could have beneficial effects on bone.

Quality is the single most important factor in the success of a product. Visit www.fortitech.com/ quality to learn more

Other Potential Bone Bioactive Ingredients Tea Habitual tea drinking has been associated with higher bone mineral density in the Womens Health Initiative Observational Study of a large number of older women (5075 years of age) in the US. Additionally, investigators in Australia found that elderly women tea drinkers had higher bone mineral density than non-tea drinkers, and had lower rates of bone loss from the hip. Animal studies have supported the possible role of green tea extracts in bone metabolism, but no human studies have been reported to date. Phytoestrogens Reduction in ovarian function in postmenopausal women leads to an increase in bone resorption and greater rates of bone loss. Isoflavones found in soy act as phytoestrogens and have been reported to protect bone from estrogen deficiency. In a paper published this year, investigators at Purdue University in Indiana found that soy isoflavones could reduce bone resorption in postmenopausal women during a 50-day study. This confirms an early report in which bone turnover was measured in postmenopausal women receiving 110 mg/day soy isoflavone supplement for six months. Positive effects of soy isoflavones on bone resorption only occur in postmenopausal women not taking hormone replacement therapy. DHEA DHEA (dehydroepiandrosterone) concentrations in blood decrease as we age. A new study has assessed the effect of DHEA supplementation (50 mg/day) on bone mineral density in older adults from Missouri that were given calcium and vitamin D supplements during a two -year study. No change in bone mineral density (BMD) was found in older men, but there was a significant increase in BMD in women taking DHEA.

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 6

2 0 1 0

PAGE

Joint Nutrients Information about the role of nutrients and bioactive ingredients in joint health is generally much less developed than that of bone health. Nevertheless, a number of potentially useful ingredients as shown in Figure 3 stand out; in particular, those that are constituents of cartilage, such as chondroitin sulfate and glucosamine, or play a role in controlling inflammation, such as omega-3 fatty acids.

Fortitech is the expert when it comes to blending multiple nutrients to create an award winning end product

Figure 3.

Joint Health Ingredients

Chondroitin Sulfate Chondroitin sulfate is an important structural component of cartilage. The Glucosamine/ Chondroitin Arthritis Intervention Trial (GAIT), a large randomized, double-blind, placebo controlled intervention study in patients with knee osteoarthritis, recently reported that patients taking 400 mg chondroitin sulfate three times per day had a significant improvement in knee joint swelling. This treatment seemed particularly effective in patients with milder levels of pain and symptoms. Glucosamine Glucosamine is a chemical precursor of glycosaminoglycan, a major component of joint cartilage has been the subject of much research as a potential beneficial aid in the management of osteoarthritis. In a three-year, randomized, placebocontrolled, double-blind study of the effects of 1,500 mg of glucosamine sulfate in patients with knee osteoarthritis, Czech investigators found that glucosamine sulfate slowed the progression of knee osteoarthritis. A similar study in Belgium also found that glucosamine sulfate prevented joint space narrowing in postmenopausal women with knee osteoarthritis. In a follow up study, these investigators found that patients who had received glucosamine sulfate for one to three years were significantly less likely to require total joint replacement surgery during the subsequent five-year period. Omega-3 Fatty Acids/Fish Oil Besides osteoarthritis, another important category of arthritic disease is rheumatoid arthritis, characterized by a systemic inflamma-

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 7

2 0 1 0

PAGE

tory disorder that can affect many parts of the body, including causing destruction of joints. Management of these patients usually involves non-steroidal anti-inflammatory drugs (NSAID) or cortisone treatment. There has been a significant interest also in using omega3 long-chain polyunsaturated fatty acids, such as are found in fish oil (EPA and DHA), in the treatment of rheumatoid arthritis. Accumulating evidence from clinical trials over the past 20 years has attested the efficacy of fish oil and n-3 fatty acids in the amelioration of symptoms of rheumatoid arthritis. For example, Brazilian researchers found that the administration of fish oil containing omega-3 fatty acids at 3 g/day over 24 weeks resulted in a significant reduction on joint pain intensity, an increase in hand grip strength, and a reduction in morning stiffness and onset of fatigue. Other Potential Joint Bioactive Ingredients Vitamin K It has been known that vitamin K can affect both bone and cartilage and that vitamin K intake is associated in cross sectional studies with radiographic evidence of osteoarthritis. In a recently published study, investigators from Massachusetts reported positive effects of vitamin K supplementation (500g/day for three years) on hand joint space narrowing in elderly subjects with insufficient vitamin K at baseline. Eggshell Membrane Natural eggshell membrane (NEM) is a patented novel dietary supplement containing glycosaminoglycans used for cartilage synthesis. A recent randomized, double-blind, placebocontrolled clinical trial in patients with knee osteoarthritis found that 500 mg/day of NEM for eight weeks had positive effects on patient joint pain and stiffness scores. NEM is a registered trademark of ESM Technologies. MSM (methylsulfonylmethane) MSM is a dietary supplement that has been used for its possible benefit in osteoarthritis. A recent randomized, double-blind, placebo-controlled study in middle aged and elderly men and women with knee osteoarthritis found that treatment with 3 g/day MSM twice per day for 12 weeks produced a significant reduction in pain and in physical function impairment. Premix Prototypes Manufacturers interested in exploring the market for bone and joint health, as well as overall wellness and other specific health benefit providing food and beverage products have a variety of applications to chose from that can be supported through premix formulations. Potential products and their respective nutrients include: Ice Cream (Bone Health) Nutrient Vitamin D3 Vitamin K1 Calcium 20 Magnesium Manganese Soy Isoflavones 15 %DV/Serving 15 25 15 30

Visit the R&D Center on fortitech.com for more info on a multitude of nutrients

mg

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 8

2 0 1 0

PAGE

Yogurt (Bone Health) Nutrient Vitamin A Vitamin D3 Vitamin E Pantothenic Acid Vitamin B12 Vitamin B6 Vitamin C Vitamin K1 Calcium Phosphorous 4 Zinc Magnesium

20

%DV/Serving 20 25 30 20 25 20 30 6 10 6

Request a free premix sample through fortitech.com

Beverage (Joint Health) Nutrient Vitamin A Vitamin D3 Niacin Pantothenic Acid 25 Vitamin B1 Vitamin B12 Vitamin B2 Vitamin B6 Vitamin C Zinc Glucosamine 150 Chondroitin Sulfate 150 Collagen Type II Undenatured Lycopene Bar (Joint Health) Nutrient Chondroitin Sulfate Glucosamine Sulfate Methyl Sulfonyl Methane Omega-3 Vitamin K1

%DV/Serving 20 30 25 20 25 20 25 30 25

10

mg mg mg 5 mg Per Serving mg mg mg 50 mg 20 mcg

100 100

100

The nutrients specified above can be used in any type of snack food/grain-based product with a combination of functional food ingredients. Fortification Challenges While all of the aforementioned nutrients can aid in bone and joint health, calcium is the one particular ingredient that consumers seek out when looking for products that address this issue. A number of market forms of calcium are available to boost a products calcium content. Food products, such as fruit juice, infant food, health food and sports beverages are most often fortified with calcium and other minerals.

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 9

2 0 1 0

PAGE

The challenge for formulators is to select an appropriate form of calcium that delivers the desired level of the mineral without affecting flavor, solubility, bioavailability, sensory properties and the mouthfeel of the finished product. Calcium carbonate is perhaps the most cost-effective source of calcium, however, it has a tendency to provide a chalkiness taste and have a gritty mouthfeel, as does dicalcium phosphate. Some of these processing issues can be prevented if a blend of calcium sources are used instead of a single source. In addition, these calcium salts are not very soluble; therefore, it is desirable to add calcium citrate or organic acid to improve solubility. In order to get the most out of these salts, a manufacturer has to decrease the pH to solubilize, which causes absorption to increase. In general, in order to have more absorption, it is necessary to have soluble calcium salts, but there are advantages and disadvantages to either soluble or insoluble forms. For example, calcium gluconate is soluble but may interact with other ingredients in the product and impact flavor. Large doses of calcium are efficiently excreted by the body and do not usually produce toxic effects unless the individual has a history of kidney stones. While suggested dietary intakes vary with different age groups and between men and women, it is commonly recommended that adults consume 1,000 mg of calcium per day. Food manufacturers must work closely with their suppliers to address product development issues that could dramatically impact nutrient delivery or alter the end product. The supplier can suggest appropriate market forms, interactions to avoid, and processing effects that will improve the chance of success. Questions to address prior to fortifying a product with ingredients aimed at improving bone and joint health include:

Fortitechs technical personnel can assist you in overcoming formulation issues

type of product to be fortified amount of various nutrients to be added, particularly if a manufacturer is trying to meet label claims whether additional ingredients should be added to enhance performance processing conditions, such as time and temperature pH of the finished product shelf life and other components of the finished product While fortified beverages have become a medium of choice for delivering healthy and functional nutrients, those in the industry know that formulating beverages can be complex, particularly when multiple ingredients are being added. There is a host of complications that can occur in beverage formulation such as sedimentation, poor taste cloudiness, or lack of uniformity of ingredient incorporation among other challenges.

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 1 0

2 0 1 0

PAGE

Adding multiple ingredients to food products and supplements can promote improved bone and joint health, as well as manage other health conditions. Good practice calls for high quality nutritional blends that address these issues, which in turn will gain consumer confidence in the product and in the role that it can play in improving their bone and joint health, as well as their overall wellness.

Fortitech is your partner in product development. Contact us via info@fortitech.com to get started

S T R A T E G I C T E C H N I C A L

N U T R I T I O N P A P E R J A N ,

F O R

B O N E

&

J O I N T

H E A L T H P A G E 1 1

2 0 1 0