Women In Mind

Eight million women in the U.S., compared to two million men, suffer from osteoporosis, according to the Society for Women’s Health Research. The American Heart Association reports nearly 40% of all female deaths in the U.S. occur from cardiovascular disease (CVD), which in-cludes coronary heart disease (CHD), stroke and other cardiovascular diseases. And 38% of women, compared to 25% of men, will die within one year after a heart attack. As these health issues and others affect more women than men, the nutra-ceuticals industry is working hard to im-prove women’s quality of life.

“The nutraceuticals industry is re-sponding by offering innovative ingredients that are uniquely capable of enhancing everyday foods to provide the dietary requirements that will ultimately assist in health and wellness development and maintenance,” said Coni Francis, PhD, RD, scientific affairs manager, GTC Nutrition, Golden, CO.

Increasing female consumer power is changing the way companies design, manufacture and market products, according to Marge Leahy, senior manager, Health and Nutrition Sciences, Ocean Spray In-gredient Technology Group, Lakeville/

Middleboro, MA. “Working women are now recognized as a key force within the marketplace, and have become one of the most important groups in the eyes of marketers. It is estimated that they make more than 75% of all purchasing decisions within the home,” she said.

It is equally important to reach girls and women of all ages, according to Dr. Francis, who said, “The earlier vital nutrients such as fiber and calcium are introduced to the diet the better, and the industry is rapidly responding with an ever-present need to introduce, or reformulate products capable of maintaining health and possibly preventing diseases such as osteoporosis and diabetes.” Unfortunately, most women start to take an interest in their nutritional needs around the age of 25, sometimes even later.

But don’t forget about the baby boomer generation. “Female baby boomers are aging and have entered a lifecycle where their attention has moved from raising their families to ensuring that their lives are as healthy as possible in their ‘golden’ years,” said Danielle Thomas, director of marketing and sales at Nutratech, Wayne, NJ. “Many of these women have witnessed the downsides of not exercising and eating right firsthand as they are the ones most likely to take care of aging parents. Their parents’ generation, as a rule, was not as enlightened about ‘self-care’ via better life choices and supplementation.”

“The media has also played a role in the surge of products formulated specifically for women,” said Ms. Thomas. “Women’s health issues are much more prominent in the mainstream media. This is partly a result of the National Institute of Health’s Women’s Health Initiative, which was launched in the 1990s to address the most common causes of death among women. This series of studies is the largest U.S. prevention study of its kind.”

Market Opportunities

GTC’s Dr. Francis believes opportunities to gear food, beverage and supplement products toward women in the health and wellness market are many, if not limitless. Whether they are on college budgets, have a successful career or caring for children, health-conscious women are all looking to maintain and improve overall wellness. As a result, Dr. Francis says they have come to demand specific health benefits in the products they purchase.

Along the same lines, Jocelyn Mathern, RD, technical specialist, Acatris Inc., Minneapolis, MN, sees the condition-specific market picking up steam. “Instead of single compound ingredients for women's health, we’re seeing more products formulated for conditions like menopause, which contain several ingredients that can act together to benefit health,” she explained. As a result, Ms. Mathern feels women will be looking for ways to not only help manage symptoms, but to also protect their heart and bone health after menopause.

A recent report, “The U.S. Market for Wo-men’s Foods and Beverages” from Packaged Facts, publishing division of Market-Research.com, estimates that the U.S. wo-men’s food and beverage market reached $4.6 billion in 2004, up 11% from $4.2 billion in 2003. More significant, however, is that the compound annual growth rate (CAGR) from 2000 to 2004 was over 80%.

Packaged Facts claims that cereal—at $2.2 billion—accounted for the largest share of women’s food and beverage sales in 2004. Next in line was the beverage category, with nearly $960 million in sales. These two categories together comprise almost 70% of the women’s food and beverage market.

“With more and more consumers be-coming health and nutrition conscious, there is potential for huge growth within the fruit juice market,” said Ocean Spray’s Ms. Leahy. “Juices are widely considered to be a healthy addition to the diet because they provide a convenient form of fruit intake. There is certainly an opportunity within this market to target females with the use of ingredients that have specific benefits for women’s health.”

In its report, Packaged Facts projects that sales of women’s foods and beverages will grow to $7.7 billion by 2009, reflecting a CAGR of just under 11% during the 2004-2009 forecast period.

Synergy is another trend taking place in the women’s health market. Ronny Hacham, vice president of development and marketing, Gadot Biochemicals Industries, Inc., Haifa Bay, Israel, offered his perspective on this development. “Gadot realizes that the industry cannot offer a single nutrient approach anymore,” he said. “You have to develop several nutrients that provide either synergistic effects or all-in-one solutions. I think you will see more companies providing these types of combinations.”

Dr. Francis agrees. “Increasingly, manufacturers are looking to introduce combinations of ingredients to formulations, as there is no one nutrient that really takes precedent over another—women rely on a unique combination of vitamins, minerals, fiber, protein and more to achieve and improve overall health.”

Nutratech’s Ms. Thomas points out that for obvious marketing reasons there will continue to be a greater emphasis placed on “proprietary blend” products that offer a point of difference such as Rainbow Light’s various women’s formulations. “You are more apt to see a single nutrient product when it is either an herbal with high consumer recognition like black cohosh or a registered ingredient where a company enjoys a trade class or market exclusivity,” she said.

“As the market for women’s health products grows, there will be huge opportunity for manufacturers to take advantage,” said Ms. Leahy, adding, “It is important to remember, however, that female consumers are not easily won over. As they continue to educate themselves on the various nutrients available, manufacturers must work hard to ensure they are responding to women’s needs. Products must be high quality, with well established health benefits and ‘on the button’ marketing.”

Investigating Soy

Plant estrogens found in soy products have recently taken center stage due to their questionable effects on human development and reproduction. For this reason, the Center for the Evaluation of Risks to Human Reproduction (CERHR) convened a panel of 14 scientists to re-view whether exposure to soy products may be hazardous to human development or reproduction. The National Nutritional Foods Association (NNFA), Washington, D.C., while supportive of inquiries that will protect human health, was concerned that the panel’s findings would be taken out of context by the mainstream, inappropriately causing consumers who benefit from soy isoflavone dietary supplements to avoid them.

Specifically, NNFA contended that the findings might not be of value to the population that is predominantly using soy products: women using it as an alternative to hormone replacement therapy (HRT) to relieve symptoms associated with menopause, such as hot flashes and bone loss.

Additionally, there seems to be some confusion over the natural compound typically found in dietary supplements—“genistin”—vs. the compound in question—“genistein.” The latter is only present in natural matrixes in very small amounts.

“It’s interesting that the panel is looking at a compound that really doesn’t occur frequently and really isn’t in the diet, even if you supplement in great abundance. And the levels they were looking at for toxicity isn’t anything close to what you would see in the body,” said Daniel Fabricant, PhD, vice president of scientific affairs, NNFA.

Dr. Fabricant attended the meeting where the CERHR panel made their final decision. “When they viewed the data, available evidence in its entirety, the CERHR supported the safety of soy use in terms of formula and genistein for women and children—it wasn’t an issue in terms of reproductive or developmental issues.”

Dr. Fabricant claims consumers should not be concerned about continuing their daily soy regimens as recommended on the label or by their healthcare practitioner. “Soy can indeed be used safely by both women and children,” he said.

“This event was picked up in a lot of the mainstream media but it was not necessarily reflective of the science that was ongoing,” Dr. Fabricant said. “We (NNFA) hope that the public continues to educate themselves and if they are going to take something, learn the issues surrounding it.”

Still, some healthcare experts are a little wary of soy supplements. “My main concern is with estrogenic exposures, such as the case with soy supplements. This concern relates to women being exposed to high levels of phytoestrogens (estrogens from plants), which can have a similar response to what we are seeing with HRT, and that might increase breast cancer risk,” said Barbour Warren, PhD, research associate, Cornell University, Ithaca, NY. Dr. Warren is also affiliated with the Program on Breast Cancer and Environmental Risk Factors (BCERF) at Cornell.

“I also worry about the herb preparations on the market when there is basically no regulation.” Dr. Warren’s final advice is use estrogenic products with caution, but soy in the diet is probably fine, although shouldn’t be overdone.

Scientists at ADM, Decatur, IL, recently completed a critical analysis of the studies looking at soy isoflavones and hot flashes in post-menopausal women. “The scientists looked at the individual isoflavones within the soy extracts to determine if there was a reason for the variation in previous studies,” said Liza Pepple, product manager, ADM. “What they found was that there was a difference. Soy isoflavones that are manufactured from the whole soybean and are therefore higher in the individual isoflavone genistein are effective in reducing hot flashes, whereas isoflavones with lower genistein levels are not.”

Plant Lignan Advantages

Lignans are phytoestrogens, naturally occurring plant estrogens, which can help balance hormone levels in women. “Because they act as strong antioxidants and phytoestrogens, lignans have been shown to have a balancing effect on hormones,” said Mary Ekman, general manager, Pizzey’s Milling USA Inc., Gurnee, IL. “The chemical structure of lignans is much like that of estrogen, and as such can compete with estrogen for binding sites thus helping to reduce the growth of certain types of cancers. Some animal studies have shown them to actually prevent mammary tumors from forming, as well as causing existing tumors to shrink. Human studies have also shown promising results. In fact, researchers have found that postmenopausal women who consumed flax- seed had reductions in tumor growth.”

According to Acatris’ Ms. Mathern, most Americans do not get enough lignans—less than 1 mg a day—a frightening fact when considering the increased risk of ma-jor diseases common to women as they age.

Ms. Ekman continued, “Flaxseed has also shown promising results in the area of bone health. Lignans can compete with estrogen. As a result, they may help prevent osteoporosis in hormone deficient women.”

New research performed by the clinical medicine faculty at the University of Insubria in Italy has added to the body of evidence supporting the use of lignan phytoestrogens to help women manage menopause. In the study, designed to establish the effective median concentration value (EC50) of Norway spruce-derived lignan, hydroxymatairesinol and its human metabolite enterolactone in comparison to estradiol, experiments confirmed a daily dosage of 10–30 mg as sufficient to raise circulating enterolactone to estrogenically active levels.

The study concluded that both hydroxymatairesinol and its metabolite enterolactone are endowed with estrogenic activity, which is likely to be exerted through estrogen receptors and target the same intracellular mechanisms acted upon by estradiol. This supports the notion that dietary supplementation with Norway Spruce lignans is beneficial for several conditions related to estrogen insufficiency.

The results offer a soft phytoestrogen alternative to help manage menopause. HMRlignan, manufactured and marketed by Linnea, Inc., Locarno, Switzerland, provides a highly bioavailable and efficient method to boost enterolactone levels. Derived from Norway Spruce (Picea abies) HMRlignan is a direct enterolactone precursor dietary supplement standardized to contain 80,000 mg per 100 grams of lignans.

The Reliable Cranberry

Urinary tract infections (UTIs) are a-mong the most common reasons women seek medical care. According to Ocean Spray’s Ms. Leahy, it is estimated that nearly 60% of women will develop a UTI at some point in their lives. “Research shows that in the U.S. alone, over nine million doctor visits are the result of UTIs, which cost Americans more than $1 billion to treat,” she said.

Antioxidant-rich cranberries have been found to help promote urinary tract health. Cranberry juice, concentrate and purée all possess anti-adhesion properties thereby preventing microbacterial infections.

“Since 1984, when initial research was carried out into cranberry juice’s unique benefits on urinary tract health, many stu-dies have confirmed that the red berry has numerous health benefits, the foremost being its ‘anti-adhesion’ effect on certain bacteria. North American cranberries contain proanthocyanidins, more commonly known as condensed tannins, which actually disable certain E. coli bacteria,” said Ms. Leahy. “Unable to stick to the walls of the urinary tract, disease-causing organisms are harmlessly flushed from the body, preventing the onset of infection.”

Recently published research also suggests that sweetened dried cranberries (SDC) contain the powerful “anti-adhesion” effects. Researchers from Brigham and Women’s Hospital in Boston tested the urine of five women suffering from an infection of the urinary tract and found an increase of as much as 50% in anti-adherence activity after consuming Ocean Spray’s reduced sugar, high fiber SDCs.

Before, During and After Pregnancy

Education in the past few decades has ensured women are aware of the fact that they should be consuming enough folic acid before pregnancy to prevent birth defects. Today, DHA (docosahexaenoic acid) intake in a woman before, during and after pregnancy has shown to be just as essential. It’s well documented that DHA reaches the fetus or baby through breast milk. Research has suggested that DHA levels be increased when a woman wants to become pregnant in order to have adequate nutrients to nurture herself and the fetus as the pregnancy progresses, as well as during nursing.

Martek Biosciences, Columbia, MD, performed a trial in which pregnant women ate eggs enriched with DHA derived from chicken consuming microalgae-fortified feed. The women ate an egg every day through the last trimester. As a result, there were fewer complications during the birth process for women who had eaten the DHA-enriched eggs. These women were at risk for early delivery, and the DHA actually lengthened gestation by as much as six days, making them closer to term or at term. The babies also exhibited much healthier weight.
DHA not only helps with birth outcomes, but it also benefits the baby developmentally. “If mom increases her wealth of DHA, whether through food or in supplements, it goes into the breast milk and directly to the infant,” said Angele Tsetsis, vice president for community affairs, Martek Biosciences. “Studies in which moms were breastfeeding and taking supplements resulted in their children having developmental advantages growing up. One of the studies showed that at two-and-a-half years of age, children whose moms took the supplements while nursing had advanced psychomotor development over the children of moms who did not supplement. It improved their visual perception and motor skills.”

There are also studies that show babies who get adequate amounts of DHA are better developed mentally, which may translate to higher IQs later in life. Furthermore, Ms. Tsetsis said, some infant and breastfeeding studies have shown that babies with higher DHA levels have better cardiovascular profiles later in life, as well as lower blood pressure.

Calcium supplementation can also benefit women during pregnancy. A major World Health Organization (WHO) study recently concluded calcium supplements could reduce pregnancy complications. Preeclampsia, the development of high blood pressure and protein in the urine during pregnancy, as well as its more severe complications like eclampsia, can threaten the lives of both mother and child. While there is no therapy to prevent preeclampsia, a link to calcium deficiency has been suggested. In a study published in the American Journal of Obstetrics and Gynecology, researchers in Argentina, Egypt, India, Peru, South Africa, Vietnam, under the auspices of the WHO, investigated whether a calcium supplement could reduce the complications and mortality from this condition.

Over 8300 women with low dietary calcium (<600 mg/day, about half of that recommended during pregnancy) were selected for the multicenter, randomized, placebo-controlled, double-blind trial. The subjects were randomly divided into two groups, which had similar gestational ages, demographic characteristics and normal blood pressures before treatment started. Half were given calcium supplement at 1.5 grams per day and half received a pla-cebo. While the incidence of preeclampsia was not statistically different in the supplemented women, eclampsia, other severe complications and severe gestational hypertension were significantly lower in the calcium group. Overall, the “severe preeclamptic complications index” and the “severe maternal morbidity and mortality index,” including all severe conditions, were also reduced with calcium.

Writing in the research article, Jose Villar, MD, stated, “This large randomized trial in populations with low calcium intake demonstrates that while supplementation with 1.5 gm calcium/day did not result in a statistically significant decrease in the overall incidence of preeclampsia, calcium significantly decreased the risk of its more serious complications, including maternal and severe neonatal morbidity and mortality, as well as preterm delivery, the latter among young women.”

There have also been studies on how adequate vitamin D consumption during pregnancy can provide health benefits to the child. One study, recently published in the Lancet, examined the effect of maternal vitamin D status during pregnancy on childhood skeletal growth. Results show-ed that children born to women who were deficient in vitamin D during late pregnancy had weaker bones at age nine than children whose mothers had adequate am-ounts of the vitamin during late pregnancy. Findings provided evidence that maternal vitamin D status during pregnancy influenced the bone growth of offspring and their risk of osteoporosis later in life.

Managing Menopause

According to Anne La Russo, U.S. president, Novogen Inc., Stamford, CT, 5000 women enter menopause everyday. Even though it’s a normal stage for every woman, it does present some very uncomfortable conditions that impact quality of life. Symptoms of menopause, such as hot flashes, can range from slightly annoying to life-altering.

It is important for manufacturers to realize how difficult it is for women to wade through the mountains of menopause information out there. A study sponsored by Novogen recently found that women are turning to a wide variety of sources for information on menopause issues, including physicians (70%), nurse practitioners (48%), pharmacists (39%), Internet (39%) and family/friends (26%) (see Table 1). Add to this the growing controversy surrounding HRT and things get even more complicated. The Novogen survey found that 38% of women perceive HRT as unsafe, while another 40% remain unsure about its effects (see Table 2). Given the confusion surrounding HRT, the Novogen study tried to find out if women are seeking alternatives and if so, are they asking their doctor about them. Thirty-one percent of wo-men did not ask their doctor about alternative treatments because they perceived them as not being open or approving of such treatments (see Table 3). And some women have given up on both HRT and over-the-counter (OTC) treatments altogether (see Table 4).

To help women find more natural alternatives to alleviate the symptoms that accompany menopause, Ms. La Russo said eight internationally recognized women’s health experts developed a comprehensive algorithm last year for the treatment of the symptoms of menopause. “The algorithm was important because it was the first time scientists agreed that for many women natural supplements, along with lifestyle changes, should be an integral component of the treatment process,” she said.

Susan Wysocki, RNC, NP, FAANP, president and CEO, National Association of Nurse Practitioners in Women's Health (NPWH), Washington, D.C., was one of the eight researchers who developed the algorithm. “Women are beginning to shy away from traditional methods such as estrogen, progesterone therapy,” she said. “There are many women who can be help-ed by a nutraceutical, such as red clover or black cohosh, to alleviate symptoms.”

According to Ms. La Russo, a study in the January issue of Menopause states that in the last 10 years more than 100 OTC products for the treatment of menopause have hit the shelves, and use of these products by midlife and older women has increased 380%, the largest of any other demographic.

But Ms. Wysocki stressed that it is important for women to find out if these nutraceutical products have been successfully tested in clinical trials and are safe. This is because there has been some concern over herbs like black cohosh and the possibility that it may cause liver problems, although the incidence of liver reaction, she says, appears to be very low.

A recent study found that Remifemin black cohosh extract, distributed by Enzymatic Therapy, Inc., Green Bay, WI, re-duced menopausal symptoms by 70% in 12 weeks, including hot flashes, night sweats, mood swings, irritability and related occasional sleeplessness. The results were similar to recent HRT study results showing Remifemin as a safe and effective alternative to HRT. Remifemin is hormone-free, does not contain plant-based estrogens and can be taken safely by women who cannot take estrogen.

There have also been many studies conducted on red clover, which has grown in interest among women and health practitioners. Novogen’s Promensil, a natural supplement made from isoflavones derived from the red clover plant, has proven successful in numerous clinical trials. A recent double-blind, placebo-controlled trial demonstrated that “red clover isoflavones supplementation significantly decreased menopausal symptoms.” In addition, the study said red clover, marketed under the brand name Promensil, has additional cardiovascular benefits, including decreasing LDL levels and improving arterial compliance and helping to alleviate vaginal dryness.

Supplementation for Osteoporosis and CVD

“Even though the visible symptoms of menopause thankfully ease at some point, Novogen’s Ms. La Russo believes it is the longer term invisible effects of meno-pause that are potentially more serious. “After menopause, when estrogen levels remain very low, bone density is lost at a much faster rate, leading to greater risk of osteoporosis and fractures,” she said. “Also, after menopause due to low levels of estrogen there are cardiovascular changes, including rising cholesterol levels.”

Novogen’s Promensil Post-Meno-pause with red clover isoflavones ad-dress both of these issues. It contains iso-flavones shown to help maintain bone and cholesterol health, as well as calcium and vitamin D, two essential vitamins and minerals for bone health.

Speaking of bone health, Rachel Agnew, RD, who is with Pharmavite, Mission Hills, CA, suggests the follow-ing five nutrients to support bone building: calcium because it helps build and maintain good bone health; vitamin D because it helps the body absorb calcium and is essential for the normal development and maintenance of healthy teeth and bones; vitamin K because it plays an essential role within two important proteins found in all bones; phosphorous because it is found naturally in the body, with approximately 85% being in the bones; and B vitamins because they help regulate homocysteine levels (some studies have shown that high homocysteine levels have a negative effect on bone health). Other important bone helpers, she said, include vitamin E, magnesium, zinc, copper, manganese, boron and vitamin C.

ConsumerLab.com, White Plains, NY, recently released test results from its “Product Review of Supplements for Bone Health,” which covered 32 adult and children’s products containing calcium and vitamin D. Sales of calcium supplements in the U.S. approached $1 billion in 2004, according to Nutrition Business Journal, making them the most popular supplements after multivitamins. Calcium is needed to build and maintain strong bones, and vitamin D is necessary for enhancing calcium ab-sorption. Calcium and vitamin D supplements can improve bone density and reduce hip fractures in post-menopausal women. But, ConsumerLab.com says, results recently published from the Women’s Health Initiative suggest that benefits are greatest in women otherwise deficient in these nutrients and when use is continual.

Seven calcium-only products passed the review, as did 18 calcium-vitamin D combination products. One combination product, however, failed the review due to lead levels—it contained more than twice the lead allowed by the State of California without a warning label. Six other combination products had the correct amount of calcium, but levels of vitamin D could not be accurately established.

Nature Made recently introduced OsteoRenew Ultra, a product specifically formulated for bone health, which contains the vitamins and minerals mentioned by Ms. Agnew. The ingredients in OsteoRenew Ultra have been proven to support bone health in more than 30 clinical studies.

As previously mentioned, women also face cardiovascular challenges. “Heart disease is the number one killer of women,” said Pam Stauffer, marketing programs manager, Cargill, Health & Food Technologies, Minneapolis, MN. “And there are a number of initiatives, such as the American Heart Association’s Go Red For Women campaign, to increase awareness among women that this is the case. Because high cholesterol is a risk factor for heart disease, we at Cargill feel it is important to educate women on ways to manage cholesterol with functional foods and beverages.” Cargill manufactures and markets the CoroWise brand of plant ster-ols, which is clinically shown to reduce bad cholesterol while maintaining good cholesterol.

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