Fit For Women

Nutritional Ingredients Address Women’s Needs Across Life Stages, Life Styles And Health Concerns 

Women of every age, height, weight and activity level have at least one thing in common: their bodies need certain nutrients to help them function properly. “From a nutrition perspective, the primary concern for women is bone health,” said Dr. Gameil T. Fouad, president of Utahbased Biotron Laboratories, Inc., a mineral supplier. “Peak bone density is reached relatively early in life and most of this tissue is generated during young adulthood—teens through the late 20s,” he said, adding that this happens to be a period of life where dietary choices suffer. “The types of foods which deliver adequate bone building nutrients, namely calcium, magnesium, protein, are also the foods that are infrequently consumed—milk, cheese, meats and fish. Vitamin D is also critical and so many of us suffer from both inadequate intake as well as inadequate exposure to sunlight. This is particularly acute in northern latitudes in winter.” 

Max Motyka, director of sales and marketing with Albion in Michigan, suggested a few important minerals that should be addressed for this category, including:

• Calcium Citrate Malate (CCM)—This CCM has a 6:2:3 molar ratio, which is the compound that has been used in many clinical studies to be very bioavailable. Additional clinical studies have shown this form of CCM to improve bone health in women of all ages: adolescents, childbearing age and postmenopausal. CCM is EFSA (European Food Safety Authority) approved.

• Magnesium Bisglycinate Chelate & Potassium Glycinate Complex—for cardiovascular health.

• Ferrochel Iron—Albion’s flagship, patented ingredient. It is a ferrous bisglycinate chelate that is a highly bioavailable and gentle form of iron. Applications include: perinatal, female aerobics athletes, etc.

• Magnesium Bisglycinate Chelate— for PMS (pre-menstrual syndrome) and preeclampsia.

Vladimir Badmaev, MD, PhD, head of R&D with NattoPharma ASA in Oslo, Norway, noted that lifestyle related disorders (LSRDs) including obesity, cancer and cardiovascular disease are also health concerns among women. “There is also a condition that is typically associated with post-menopausal aging population, osteoporosis or age-related loss of bone mass/strength that can be aggravated by the LSRDs and poor nutrition, especially related to insufficient absorption and misdirected metabolism of calcium in the body,” he said. “Calcium, the most abundant mineral in the body, may also hold a key role in supporting cardiovascular health and general health.” 

A Calcium Conundrum 

Despite its known benefits, Badmaev noted that recent epidemiological studies indicate that supplemental calcium intake may put women at cardiovascular risk e. g. use of calcium supplements with or without vitamin D was associated with a significant 24 percent increase in risk of coronary heart disease in a cohort of 10,555 Finnish women.

“There are other epidemiological studies with a similar conclusion on calcium supplementation increasing cardiovascular risk,” he said. “Enter the paradox of calcium: supplemental calcium is crucial for the maintenance of a strong skeletal system and teeth, but also for nerve transmission, blood coagulation, vascular tone, blood pressure, muscle contraction, enzyme activation and hormone regulation. On the other hand, several recent epidemiological studies as mentioned—including the results of a 2013 JAMA-published study—indicate that supplemental calcium and vitamin D (which increases absorption of calcium) may be detrimental to cardiovascular health, presumably by increasing arterial calcification.” 

Badmaev explained that calcium is a central element in the physiological role played by the GLA proteins. “On the other hand calcium cannot be properly utilized by the body without GLA proteins and vitamin K,” he noted. “Vitamin K2 in particular is responsible for carboxylation and activation of osteocalcin, which is essential for bone building cells, osteoblats. K2 helps in carboxylation and activation of another protein besides osteocalcin, matrix GLA protein (MGP), for elasticity and prevention of calcification of blood vessels. This dual function of vitamin K2 is sometimes referred to as the vitamin K paradox: vitamin K2 helps build calcium deposits in the bone via carboxylated (activated) osteocalcin, while it has the opposite effect on the circulatory system by activating the MGP which prevents calcium deposits in the arteries and is one of the most potent arterial calcification inhibitors known.” 

“Unfortunately despite the critical role as calcium chaperone recent epidemiological studies suggest that most healthy adults and possibly children may insufficient in vitamin K, especially K2 that is produced by friendly bacteria,” Badmaev added.

Tired and Stressed

While heart and skeletal issues are a top priority with women, Dr. Paul Clayton, chief scientific advisor with Californiabased Gencor, explained that depression, stress and fatigue are other issues reported by women. “While these factors have numerous causes, there is a growing awareness that they are all associated with another common condition called hypoactive sexual desire disorder (HSDD), or loss of sexual desire. Surveys indicate a prevalence of 20 to 35 percent in pre-menopausal women and 45 to 65 percent in post-menopausal women. HSDD has real and sometimes devastating effects, including depression, anxiety and stress, which can result in relationship difficulties,” he said.

Deanne Dolnick, vice President of Next Pharmaceuticals based in California added that weight loss will always stay top-of-mind with women. “That will probably never change,” she said. “After that there are a host of health concerns including but not limited to fatigue/exhaustion, stress/anxiety, breast cancer and other cancers. I do not believe that women worry about perimenopausal and menopausal symptoms until it hits them in the face. It is one of those issues that is not on the radar until all of a sudden … it is on the radar.” 

Next Pharmaceuticals produces Relora, a patented and proprietary blend of Magnolia officinalis bark extract and Phellodendron amurense bark extract. Studies have shown that it has the ability to assist in weight management, significantly decrease stress, improve sleep, decrease carbohydrate cravings and aid in cortisol balance, said Dolnick.

State of the Market 

A random survey of U.S. adults (The Slone Survey) examined patterns of medication use, including dietary supplements as well as prescription medications and OTC drugs. The survey found that 40 percent of adults used vitamin or mineral supplements in the week before the survey. Like other studies, it found that usage was higher among women than men and increased with age in both groups.

“The market for women’s health ingredients is growing at about nine percent per year, driven by an increasing prevalence of female health issues,” Clayton said. “At the same time, health care costs are rising, leading to delayed and forgone care. Women are looking to dietary supplements to replace some traditional medical care, and prevent more serious issues from developing.” 

In addition, women buy the majority of supplements not only for themselves but also for their families, Dolnick said. “Women’s health issues will always be on the forefront of the dietary supplement industry and as more health care professionals begin to recommend supplements, women’s categories will continue to grow.” 

With so much recent research news, vitamin D has caught the attention of consumers and is an expanding category, said Fouad. “There has been some discussion of raising the recommended daily intake for this nutrient and its benefits are thought to extend beyond bone health to include cardiovascular health. Vitamin D may confer some protection against the development of cancer as well. What is certain is vitamin D’s role in calcium absorption and the prevention of osteoporosis.”

However, the conflicting reports regarding the risks and benefits of calcium have been publicized, so the state of the market for this important nutrient has been less robust, Fouad said. “Despite the headlines, I think it’s important to consider two realities: First, calcium is the most abundant mineral in the body and plays a role in many metabolic processes, beyond bone processes, such as neurotransmission and muscle contraction. Second, large scale population based surveys such as the Third National Health and Nutrition Examination suggest that more than eight million women have osteoporosis and in fact much of this can be attributed to the fact that women are failing to maximize bone mineral density during peak bone building years.”

As for vitamin K2, according to Eric Anderson, global vice president of sales and marketing with NattoPharma, the global natural market is still relatively new, with a growth rate of 20 percent per year. “However, K2 is the ‘forgotten vitamin’ as vitamin K1 is adequate in the Western diet,” he said. “Just as different B vitamins offer different benefits, vitamin K2 plays a different role than K1 in supporting bone and cardiovascular health, and these benefits are just now becoming known. With new research and technology of vitamin K2, i.e. MenaQ7-®Crystals, showing preservation of bone health, and improvement in arterial elasticity in healthy women, the market is poised to explode.” 

Health Studies 

Last spring at the Experimental Biology meeting in Boston, MA, Biotron reported the results of a recent clinical study on a new form of calcium amino acid chelate. This material was compared against calcium carbonate in a double blind crossover study in healthy premenopausal women. The results showed that the calcium amino acid chelate was absorbed more quickly and in greater amounts than the carbonate form. Moreover, there was a statistically significant reduction in the amount of parathyroid hormone (PTH) found in the blood of those patients receiving the chelate. PTH drops in response to serum calcium—suggesting that not only is the calcium being well absorbed, but is also having a biological effect in the body.

“In other words,” according to Fouad, “the material truly shows improved ‘bioavailability’ in that it is better absorbed and has a measureable effect. In this acute setting, the safety profile was indistinguishable between the two test products according to a panel of standard lab tests and as with other mineral chelates is very well tolerated. We’re very excited about these results, but as is always the case with R&D, more work remains to be done.” 

Science has benefitted NattoPharma, and Badmaev said that despite the strong epidemiological evidence showing that dietary intake of vitamin K2 may improve overall health status, it was not until the three-year study of MenaQ7 brand—a natural supplement of K2 as MK-7—completed in 2012 (Osteoporosis Int. 2013), that there had been a clinical trial to show that only a long-term (more than one year) supplement of vitamin K, especially MK-7, improves bone mineral density, bone mineral concentration and bone strength.

The study was a double-blind randomized clinical trial evaluating the results of a three-year regular intake of natural MK- 7 in an 180 mcg daily dose by a group of 244 healthy post-menopausal Dutch women, 55 to 65 years old, randomly assigned to receive either MenaQ7 or identical-looking placebo capsules daily, he said. Specifically, with regards to bone preservation, the study showed significant protection of the vertebrae and the hip (femoral neck) against osteoporosis and fractures due to osteoporosis. This was achieved with only 180 mcg daily of MenaQ7, which is considered a ‘nutritional dose,’ meaning it is a dose that can be obtained from a healthy balanced diet.

The cited three-year study also showed substantial benefits of nutritional vitamin K2, as compared to the placebo group, in preventing age-related stiffening of arteries manifested by a significant increase of the pulse wave velocity—a sign of aging and hardening of arterial walls (age-related calcification of arteries).

Studying Libido 

When it comes to research into natural ingredients for sexual health, almost all of it applies to men, noted Clayton. “The reputation of sexuality products has been marred by product recalls and they have risen to the top of the FDA’s (U.S. Food and Drug Administration) most watched list. That’s why Gencor’s scientifically validated research into women’s sexuality is so important.”

In 2011 and 2012, Gencor commissioned an eight-week, randomized, placebo-controlled, double blind clinical trial of the effectiveness of Libifem for supporting female sexual desire, libido, hormone levels and metabolism. The aim of the clinical trial was to evaluate the effect of a specific extract of Trigonella foenum-graecum (fenugreek) on libido, hormonal profile and metabolism in healthy, menstruating women with regular menstrual cycles. The study utilized an innovative approach: While most intervention studies on female sexual function are done on menopausal or postmenopausal women, this study focused on healthy menstruating women, where all blood and hormone parameters were measured during the same three days of the follicular phase of the menstrual cycle. This allowed researchers to capture a picture of hormone levels at a set period of time in healthy menstruating women, therefore being able to see real changes in hormone profiles correlate changes to the treatment with Libifem.

Sexual function was measured using the Derogatis Interview for Sexual Functioning (DISF-SR-Female) standard interview designed to provide the quality of an individual’s sexual functioning in quantifiable terms. The study found that subjects taking Libifem showed a statistically significant increase in all domains and the total score of the DISF-SR. Subjects also perceived a reduction in fatigue, maintained consistent metabolic activity, and experienced a perceived boost in mood. Study participants described the effects as “truly remarkable.”

Menopause 

Much has been discussed about soy and menopause and according to Julio R. Lopez Cintron, PhD, marketing manager at Illinois-based ADM Food and Wellness, the interest stems from observational evidence in Japan, where researchers have found the low frequency of hot flashes in Japanese women might be attributed to high levels of soy consumption that often begins in utero and continues throughout their lifespan.

Evaluating the effects of soy isoflavones, naturally occurring compounds found in soy that exert a mild estrogen-like effect, the authors found:

• Ingesting at least 54 milligrams of soy isoflavones daily for six weeks to one year reduces menopause hot flash frequency by 20.6 percent and severity by 26 percent, compared to a placebo.

• The total reduction in frequency and severity might be even greater due to the placebo effect.

• In longer duration studies (where women consumed soy isoflavones for 12 weeks or more), the decrease in hot flash frequency was approximately threefold greater than in shorter-duration trials.

• Isoflavone supplements with higher levels (at least 19 milligrams) of genistein, one of the two main types of isoflavones, were more than twice as effective at reducing hot flash frequency as lower amounts.

The study concluded that soy isoflavone supplements, derived by extraction or chemical synthesis, are significantly more effective than placebo in reducing the frequency and severity of hot flashes.

Gencor’s Clayton noted a 156- patient, double blind, randomized, placebo-controlled clinical trial was conducted using Genopause, the company’s blend of four ayurvedic herbal extracts. The subjects were 40-60 years old and had ended their menstrual cycles one year prior. Genopause showed a reduction in many areas, including hot flashes, insomnia, mood, fatigue and nervousness, Clayton said.

Lifestyle 

While many woman take on the responsibility of looking after their loved ones’ health, Fouad said he is the supplement provider at home. “My wife can tell you that I recommend two ingredients for bone health: vitamin D and calcium,” he noted. “I place her supplements on the countertop after dinner each night; she calls it her ‘pile of pills.’ It’s taken us some experimentation to identify those products she can take without complaining of uncomfortable side effects and those she tolerates well.” 

Supplementation alone can’t do the job however, he added. “From the standpoint of bone health, whether we’re talking about achieving peak bone density or maintaining bone density in later years, they key is load-bearing exercise in addition to adequate nutrition. Activities that are mildly strenuous such as gardening or walking up and down stairs to more rigorous activity such as weight training in a gym, hiking, skiing etc. all confer benefits to bone health. They key is to engage in such activity often.” 

Dolnick explained that Next Pharmaceutical’s Relora works by helping to calm the hypothalamic-pituitaryadrenal (HPA) axis. “The HPA axis is always being stimulated, but in some people it is constantly over-stimulated which leads to an excess secretion of cortisol. Excessive cortisol levels not only disrupt sleep patterns, but over an extended period of time can lead to chronic stress and anxiety, inflammation throughout the body, autoimmune disorders and the list goes on,” she said.

“What we forget is that everything is interconnected and so sometimes if we can keep one thing in check, such as the HPA axis, we can potentially alleviate a litany of health problems.” 

Resources: 

Taku, Kyoko, Melissa K. Melby, Fredi Kronenberg, Mindy S. Kurzer, and Mark Messina. “Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials.” Menopause 19, no. 7 (2012): 776-790.

Artika R. Casini. Soy and menopause: L=largescale study finds soy may alleviate hot flashes in menopause. Available at: www.udel.edu/udaily/ 2012/apr/melby-soy-menopause-040412.html. Retrieved 03/04/2014. 

Extra! Extra!

Visit www.niemagazine.com to read of list of botanicals natural practitioner Adam Killpartrick, DC, recommends to patients seeking hormone balance.

FOR MORE INFORMATION: 

ADM Food & Wellness, (800) 637-5843 
Albion, (586) 774-9055 
Biotron Laboratories, Inc., (801) 298-8438
Gencor, (949) 502-5760 
NattoPharma USA, (609) 454-2992 
Next Pharmaceuticals, (831) 621-8712

Supported Findings 

Max Motyka, director of sales and marketing with Albion noted several health studies that examined minerals beneficial to women’s health. They include: 

• Calcium and Vitamin D during pregnancy—Effect of Calcium Plus Vitamin D Supplementation During Pregnancy in Brazilian Adolescent Mothers: A Randomized, Placebo- Controlled Trial Am J Clin Nutr; 2013 May 29 [Epub ahead of print]. Diogenes ME, et al.

The study examined how pregnancy and lactation in adolescents with habitually low calcium intake may adversely affect maternal bone mass. Calcium plus vitamin D supplementation during pregnancy of adolescents with low calcium intake was found to result in higher lumbar spine bone mass and a reduced rate of femoral neck bone loss during lactation.

• Magnesium and inflammation— Maternal Magnesium Supplementation Reduces Inrauterine Growth Restriction and Suppresses Inflammation in a Rat Model Am J Obstret Gynecol; 2013 May; 208(5):383. Roman A, et al.

Intrauterine growth restriction (IUGR) is associated with increased inflammatory responses. Magnesium was studied for attenuation of inflammation and IUGR in a rat model. Maternal oral MgCl2 supplementation was found to reduce Blinduced IUGR by 64 percent and suppressed cytokine/chemokine levels in the AF and PL.

• Iron, Potassium, Zinc and Premenstrual Syndrome—Intake of Selected Minerals and Risk of Premenstrual Syndrome Am J Epidemiol; 2013 May 15; 177(10):1118-27. Chocano-Bedoya PO; et al.

Iron, potassium, zinc, and other minerals were studied for their impact on the development of premenstrual syndrome (PMS). Findings suggested that dietary minerals might be useful in preventing PMS.

• Glucosamine, Amino Acids, Minerals, and Antioxidants on Aging Skin—The effect of an oral supplement containing glucosamine, amino acids, minerals and antioxidants on cutaneous aging: a preliminary report. Murad H and Tabibian MP. J Dermatolog Treat 2001 Mar;12(1):45-51.