At first glance, it may appear that the women’s market for dietary supplements and functional foods seems voluptuously crowded. Among the numerous supplements and remedies designed to support a variety of feminine health issues, some standout products exist: Amerifit Nutrition’s Estroven line, French Meadow Bakery’s Women’s Bread and Zoe Foods’ Flax & Soy cereal. So is there more room for product innovation in the women’s health arena? Absolutely.
Continuing medical research in epidemiology and mechanistic trials illuminate areas where opportunity for product development exists. Tangentially, raw material providers have found ways to apply and adapt particular compounds to address these open areas.
As for indications, most experts point to menopause (peri- and post-), and conditionally related osteoporosis, and cardiovascular disease, and the emerging area of urinary tract health as key women’s health issues they have identified through research and consumer desire for solutions (e.g., market entry opportunities).
UTIs in the Spotlight
Perhaps the area of women’s health that has most recently seen a flurry of activity, both in research and in product development, is urinary tract health. Approximately 80% of women worldwide will endure at least one urinary tract infection (UTI) during their lifetime. According to the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH), Bethesda, MD, UTIs account for about seven million doctor’s visits and 1.3 million emergency room visits each year. “Women are particularly prone to UTIs for reasons not yet concretely understood,” said Doug Klaiber, general manager, Decas Botanical Systems, Wareham, MA. “Nearly 20% of women who develop a UTI will develop another, and 30% of those will develop yet another UTI.” Of that last group, Mr. Klaiber said, 80% will have continuing recurrences.
UTIs are often treated with antibacterial drugs for one to two weeks. Sherry Torkos, BScPhm., scientific advisor to Proprietary Nutritionals, Branford, ON, writes in her booklet, The Benefits of Berries, “More than 90% of UTIs are caused by the bacteria E. coli…Once present in the urinary tract, E. coli bacteria attach themselves with tiny hairs to the mucous lining of the urethra and bladder. Securely anchored in place, the bacteria are able to multiply and infection becomes established.”
Cranberries have been shown to inhibit E. coli’s ability to adhere to the urinary tract lining by as much as 80%, and studies point to the proanthocyanidins existing in the cranberries as being responsible for this action. Through thwarting the bacteria’s penchant for adhesion, the infection simply gets swept out of the body through urination. In addition, cranberries are both astringent and diuretic, which assist in the blockage and removal of the nefarious bacteria. A 2002 year-long, double-blind, controlled study appearing in the Canadian Journal of Urology, looked at the effects of a particular cranberry compound alone with placebo juice, cranberry juice alone with placebo tablet and placebo; 150 women were divided evenly into groups of 50. The study authors concluded that the cranberry compound (tablet) group had the fewest occurrences of UTI during the 12 months.
More recently, reported Mr. Klaiber, the NIH announced a $2.6 million initiative to support research and clinical trials on the role of cranberry in the prevention and treatment of UTIs, using cranberry juice cocktail, concentrate and encapsulated powders. As of February this year, NIH awarded nine grants. Two of the studies will endeavor to reveal how cranberry behaves in the body and interacts with drugs; four will seek the efficacy of cranberry to prevent UTIs. (The NIH also included a study looking at cranberry for dental health.)
Due to the etiology of UTIs, women of all ages are susceptible, and therefore, the realm of opportunity includes marketing products for a wide range of the female population.
The Mid-Life Years & Beyond
As women enter mid-life, they begin to deal with the realm of symptoms leading to and through menopause (cessation of menstruation), which brings about numerous symptoms and changes that accelerate the precipitation of increased risks of cardiovascular disease and osteoporosis. Attaining strong health post-menopause became a focus of study for the National Heart, Lung and Blood Institute, part of NIH, which established in 1991 the Women’s Health Initiative (WHI). Enrolling approximately 161,000 generally healthy women classified as post-menopausal, several trials were designed to test the clinical effects of hormone therapy combined with diet modification, plus supplemental calcium and vitamin D.
The latest news is that the estrogen-alone hormone therapy was terminated in February because it was not only found to be ineffective on coronary heart disease risk, but was also discovered to significantly increase the risk of deep-vein thrombosis (the four-year trial involved nearly 10,800 healthy post-menopausal women ages 64 to 70 who did not have a uterus). This provided landmark knowledge: According to WHI, approximately 10 million American women were on some form of hormone therapy. As such, this failure should motivate research and development in the nutraceuticals arena.
“It is estimated that by the year 2020, more than 45 million American women will be in their 50s,” said Vladimir Badmaev, PhD, MD, scientific advisor to Sabinsa Corporation, dually based in Payson, UT and Piscataway, NJ. “Although they will be facing the possibility of hot flashes and mood swings, the increased risk of cardiovascular disease related to menopause is a more serious threat to women’s health—cardiovascular disease, especially coronary artery disease, is the leading cause of morbidity and mortality in women over the age of 50.”
In tandem, “Osteoporosis is another silent disease in women’s health,” offered Jennifer Causey, MS, PhD, research scientist with Glanbia Nutritionals, Inc., Monroe, WI. “The slow loss of mineral from bone structure is not easily replaced.”
The umbrella category of natural-based support for menopause brings forth both short- and long-term issues for address. “Much of the adult female population in the U.S. is either going through menopause or is near this stage,” said Jocelyn Mathern, RD, technical specialist, Acatris USA, Minneapolis, MN. “Therefore, many health issues affecting women are related to menopause, such as dealing with the uncomfortable symptoms of menopause and the increased risk of heart disease and osteoporosis associated with the decrease of estrogen after menopause.”
From the experience of Tova Arditi, scientific advisor for Solbar, Ashdod, Israel, women’s concerns remain focused on menopausal symptoms from pre- to post-menopausal phases, and both in symptoms and major health risks afterwards.
Solutions for the Short Term
Approximately 35 million American women are currently peri-menopausal, according to women’s health expert Susan Love, MD. Discomforts that lessen daily quality of life during the peri-menopause include hot flashes, night sweats and irritability, among other annoyances. Recent research on naturallyoccurring substances, such as soy and red clover constituents, and black cohosh, have shown clearly some benefit overall.
A British 12-week double-blind, placebo-controlled investigation by the U.K.-based Natural Menopause Advice Service found that the composition of a particular isoflavone-rich supplement improved five of the most common complaints of menopause. After three months, the supplement group had a 31% decline in severity and number of night sweat episodes and a 69% reduction of insomnia, compared to 2% and 21%, respectively in the placebo group.
“A number of studies have shown that consuming both soy protein and isoflavone extracts can help reduce the severity and frequency of hot flashes,” said Kip Underwood, marketing director, The Solae Company, St. Louis, MO. He added that consuming soyfoods or supplements will not provide the equal impact of symptomatic reduction provided by hormone replacement therapy (HRT), but the HRT risks should also be kept in mind.
In a move that bodes well for the botanicals industry, a one-year study is well underway at Northwestern Memorial Hospital in collaboration with researchers at the University of Illinois Chicago (UIC)/NIH Center for Botanical Dietary Supplements and Northwestern University to determine the efficacy and role of black cohosh and red clover in relieving symptoms of menopause. Specifically, researchers want to assess whether the botanicals can decrease frequency and intensity of hot flashes and other symptoms. Equally important, lead researcher Stacie Geller and her colleagues have already completed a Phase I clinical trial of both botanicals in 30 women, concluding they were safe for use in an expanded trial.
Red clover has also been effective in four separate studies in two years at providing comfort during menopause. For example, one trial (van de Weijer, et al 2002) showed a 44% decrease of hot flashes compared to placebo; the treatment group in a separate 16-week trial showed a 48.5% reduction of daily hot flash frequency, compared to 10.5% in the control group.
According to Allondra Stevens, marketing services manager for Benicia, CA-based InterHealth Nutraceuticals, Polygonum cuspidatum is another botanical high in phytoestrogenic activity that has been shown to help reduce hot flashes and balance mood swings.
Overall, noted Mindy Kurzer of the department of food science and nutrition at the University of Minnesota, “The strongest data show that phytoestrogens reduce the number and intensity of hot flashes, although the reduction is a modest 10-20%.”
However, HRT is not “evil”, and it does have its proven merits in providing significant symptomatic relief. In fact, several women still take it, and many are combining HRT with more gentle natural products. According to the British Medical Journal, a survey of 734 New Zealand women who were taking HRT when the first HRT study was halted in 2002, indicated that of the 423 who ceased the therapy when they read about the results, 132 (18%) had recommenced. Of those, 100 did so because of the return of symptoms.
After women endure menopause, their risks of suffering from cardiovascular and osteoporosis-instigated adversity rise drastically, due to the significantly altered hormonal blueprint typical of the elderly female body. (To a lesser degree, this condition also brings about higher weight and fat, and decreased lean muscle. These body composition issues, in turn, affect glucose tolerance. It is not that unusual for post-menopausal women to be diagnosed with adult onset, or type II, diabetes.)
Here, it is not only the late middle-aged and elderly women to whom manufacturers can market heart and bone support products. Women in their peri-menopausal years, and those in their mid- to late 30s keenly understand and embrace the prevention principle.
Sabinsa’s Dr. Badmaev pointed out succinctly that “heart disease still remains the leading cause of mortality among post-menopausal women,” shattering the long-held myth that deadly heart problems were a man’s disease. “The consensus opinion is that decline in menopausal women is due to disrupted hormonal play on a monthly basis,” he added.
Both Sharon Rokosh, market development specialist, Purac America, Lincolnshire, IL, and Susan Crowley, trade marketing specialist, DMV International, Delhi, NY, pointed to a specific factor in cardiovascular disease among post-menopausal women—hypertension. “High blood pressure is a growing problem for women,” noted Ms. Rokosh. Said Ms. Crowley, “Until menopause, women are protected to some extent from increases in blood pressure. After 50 or so, there is a dramatic rise in hypertension in women.”
Ms. Rokosh commented further that some research focusing on potassium deficiency has yielded intriguing results. “Potassium plays a significant role in the electrophysiologic properties of the heart. Studies have shown potassium depletion has significant, deleterious influences that increase the risk of hypertension, atherosclerosis, heart failure and stroke,” she said.
InterHealth’s Ms. Stevens noted that CoQ10, the omega 3 fatty acids DHA and EPA, garlic, vitamin E and green tea extract are well clarified compounds for inclusion in heart-support formulas and functional foods aimed at women. Furthermore, Ram Chaudhari, PhD, senior executive vice president of research and development for Fortitech, Schenectady, NY, stated that cardio formulas for this audience can also include vitamins B12, B6 and folic acid, as well as antioxidant vitamins C and E, and alpha lipoic acid.
Antoixidants have been the focus of a few studies determining their potential for post-menopausal cardiovascular sufficiency. In one study, by Osganian et al (Am. J. Clin. Nut., 2003;77:1390-9), Harvard researchers studied dietary intakes of particular carotenoids and incidence of coronary artery disease in 73,000 female nurses over 12 years. They concluded that women who consumed the highest levels of alpha- and beta-carotenes were least likely to suffer heart attacks.
In another study, by Sesso et al (J Nutr, 133(7):2336-41), data extrapolated from the cohort of the Women’s Health Study found that those women who consumed the highest amount of lycopene (seven or more servings of tomato-based foods) showed an approximate 30% reduction in cardiovascular disease.
According to the National Osteoporosis Foundation, Washington, D.C., osteoporosis is the second-leading healthcare problem after cardiovascular disease, affecting one in two women ages 65 and older. The promotion of bone health in the prevention or lessening of severity of osteoporosis is extremely well known, but consumer demand for bone support products still remains high.
Mr. Underwood of The Solae Company noted that there is preliminary research suggesting that soy protein consumption may result in improved bone health. Specifically, two research studies based on soy protein with higher isoflavone levels suggest bone density increased “significantly” in post-menopausal women after six months. An additional study, Mr. Underwood said, concluded that soy protein may enhance the body’s ability to maintain calcium stored in the body.
DMV’s Ms. Crowley asserts that “the calcium market is mature; consumers believe in calcium. But as women become more knowledgeable about the connection between diet and bone mineral density, they are starting to understand the importance of other bone minerals such as magnesium and phosphorus, which must be delivered in the right proportion to ensure strong and flexible bones.”
In agreement was Ms. Causey of Glanbia Nutritionals, who pointed to magnesium and phosphorus as necessary for “optimal bone scaffold strength. Milk and milk-derived calcium sources provide a similar ratio of minerals to that found in healthy bone,” she said.
Ms. Rokosh observed that the trend of offering more calcium-fortified products is growing at a rapid rate. In agreement was Hilary Hursh, food and nutrition scientist for Orafti Active Food Ingredients, Malvern, PA, who said, “Many women are consuming calcium-supplemented foods in order to maintain bone density in an attempt to ward off osteoporosis.” Ms. Hursh noted that 8 grams a day of a chicory-derived inulin has been demonstrated in a study to boost calcium absorption by up to 18%.
The next maturation step for calcium appears to be its bioavailability, an issue that has come to the forefront over the last couple of years. Gilbert Gluck, CEO of Cyvex Nutrition, Inc., Irvine, CA, says, “The issue of calcium bioavailability is the critical factor being recognized in the scientific and medical community.”
Nutraceutical Product Considerations
Now that key areas of opportunity for product development have been identified, there are some trends and thoughts as to how nutraceutical compounds should be used. Consider women’s lifestyles and the convenience factor; both tablets and capsules, as well as functional foods and beverages, are sensible and should be well received. Also to be kept in mind is the research factor. Increasingly, women are drawn toward products that purport to be backed by science. According to the Natural Marketing Institute’s Health & Wellness Trends Database, 65% of women preferred to purchase supplements that have been clinically proven to be effective. Additionally, over half of the women surveyed said proven clinical research has considerable impact on the believability of a supplement health claim.
Discussing trends in multi-ingredient formulations was Ms. Stevens of InterHealth, who said they are gaining in popularity among women. She offered, “In a very competitive market, every manufacturer is vying for shelf space and ultimately, consumer appeal. Today’s women want comprehensive yet uncomplicated products to provide them with as many health benefits as possible.”
But a kitchen sink approach may backfire; today’s savvy woman, Ms. Stevens added pointedly, is skeptical when confronted with a bevy of nutrients purporting to address varied, unrelated health areas. Pairings of nutraceuticals with similar mechanisms of action continue to be a viable approach. Said Ms. Hursh of Orafti, “Including too many functional ingredients may overwhelm customers and drive up costs, while using a single-compound approach would not have that great an impact.”
Nikos Linardakis, MD, president and CEO, Tharos Laboratories, Inc., Foxboro, MA, feels it’s best to begin with a single, clearly focused concept. He said, “Simply combining ingredients doesn’t necessarily offer the known benefits. The bottom line should always be: is there enough of the active ingredient present in the product to have the measured and desired effect in the body?”
When it comes to multi-ingredient formulations, affirmed Ms. Mathern of Acatris, a key issue is getting an efficacious amount of all ingredients in the tablet or capsule, food or beverage. “When it comes to extracts versus whole foods, a concern is that by concentrating one nutrient, others are lost. Using soy as an example, Asian women, who consume more soy than American women, have less menopausal symptoms. But when soy is eaten in countries like Japan, it is usually the whole soy food and not isolated soy protein or isoflavones. Soy also contains many other nutrients including fiber and essential fatty acids (EFAs). Some researchers believe it is the combined action of all soy’s components that provide the health benefits.”
According to Mr. Chaudhari of Fortitech, the functional food area is a tremendous opportunity for women of all ages. “The issue we deal with sometimes is seeking the ability to precisely measure how micronutrients work with macronutrients in specific food matrices,” he explained.
In summation, Deanne Dolnick, MS, education manager for Los Angeles, CA-based Soft Gel Technologies, Inc. (SGTI)/OptiPure, stated that since women are the majority of those who purchase supplements for themselves and their families, the industry needs to cater to them. “For those companies that do not, they will lose a large market share of the industry.”
About the author
Lisa Schofield is a freelance writer. She can be reached at 732-431-7509; E-mail: [email protected].