Beauty

Blood Sugar

Brain Health

Contract Manufacturing

Delivery Systems

Digestive Health

Food & Beverage

Heart Health

Herbs & Botanicals

Immune Support

Joint & Bone Health

Omega-3

Protein

Science

Sports & Energy

Stress & Sleep

Vitamins & Minerals

Weight Management

Women's Health

News

All News

Regulatory

Trends & Business

Media

Webcasts

Podcasts

Awards

Fun Facts

Publications

E-Books

Conferences

Subscribe

Resources

e-Learning Tools

Industry Insights

Nutritional Outlook is the leading news resource for manufacturers of dietary supplements, healthy foods, and nutrition beverages, from research to regulations.

About Us

Advertise

Contact Us

Editorial Submissions

Editorial Advisory Board

Do not sell my Information

Terms and Conditions

Privacy

Nutritional Outlook

Facebook

LinkedIn

Spotlight

 Contract Manufacturing

Topics

1rem

Authors

 A healthy body and mind are essential to athletic performance. Silvi Siddhu, Technical and Scientific Manager for Nutraceuticals at Univar Solutions talks about the beneficial role of prebiotics in active nutrition. There is a bidirectional relationship between exercise and composition of the gut microbiota.  Modifying the gut microbiota may help improve overall health, energy availability, exercise performance and recovery. Prebiotics selectively enhance the growth of healthy microbiota and supplements containing prebiotics or synbiotics are beneficial in exercise performance and recovery. Regardless of age or activity type, people are looking to fuel their workouts and lifestyles in an effort to promote physical, mental and cognitive health with a focus on longevity and quality of life. For an active sports person or a fitness enthusiast, taking care of gut health is beneficial for overall health. 

The Importance of Prebiotics in Active Nutrition

Prebiotics for Fitness Enthusiasts

OmniActive Health Technologies (Bridgewater, NJ and Mumbai, India) has announced a partnership with the Council for Responsible Nutrition (CRN; Washington, D.C.) to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. This knowledge will be shared at The American College of Obstetrics and Gynecology’s (ACOG) Annual Clinical & Scientific Meeting. OmniActive is 

one of six companies CRN has partnered with

 to showcase the latest research and developments in prenatal nutrition through a specially designed “Prenatal Nutrition Center” at the conference. 

“It’s wonderful to have OmniActive as one of our featured partners during the ACOG annual event to help spread the word on the importance of prenatal nutrition,” said Andrea Wong, PhD, senior vice president, Scientific & Regulatory Affairs for CRN, in a press release. “CRN continues our efforts in supporting supplement manufacturers and ingredient suppliers in bringing clinically studied products to consumers to help meet their nutritional needs. Advancing awareness at the physician’s level is a huge part of this equation and this meeting is an effective way of reaching them.”

Citing market research from SkyQuest Technology, OmniActive explains in its press release that prenatal supplement sales were estimated to be at $740 million in 2023 and projected to rise to $1.4 billion by 2031. Similarly, a recent 

 found that about 60% of gynecologists think that 80-100% of their pregnant patients take dietary supplements. There is therefore a great deal of opportunity to grow and advance this category. Lutein and zeaxanthin are known for their support of eye health, but these benefits are relevant during pregnancy as well, says Deshanie Rai, PhD, FACN, vice president of Global Science, Regulatory and Advocacy at OmniActive Health Technologies.

“Current evidence supports the preferential accumulation of lutein and zeaxanthin in the human eye and neural tissues during pregnancy, especially during the third trimester. This suggests that lutein may play a functional and protective role in infant visual and cognitive development. As part of our Lutein for Every Age campaign, our goal is to help educate healthcare practitioners on this latest nutritional science research and the benefits of achieving adequate dietary lutein during pregnancy,” said Rai, in a press release. “OmniActive is proud to partner with the CRN Foundation’s Prenatal Nutrition Centre to promote awareness among healthcare practitioners on the nutritional relevance of lutein for both mom and baby.”

The educational initiative, “Lutein for Every Age,” focuses on raising awareness of early and consistent lutein and zeaxanthin intake to help support eye, cognitive, and general health throughout life, explains OmniActive. The AOCG meeting is taking place from May 17-19, 2024 in San Francisco, CA.

OmniActive Health Technologies has announced a partnership with the Council for Responsible Nutrition to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. 

Topic

OmniActive partners with CRN to raise awareness about macular carotenoids for prenatal health

conference, October 9-11, in Salt Lake City, Utah, the Council for Responsible Nutrition (CRN) first held the WellComms forum—six presentations intended for marketing and communications professionals. In the first presentation, Brian Yam, VP of Regulatory Affairs and Quality Assurance at Blue Ocean Regulatory Inc. presented, “How To Last in the Amazon Game – How Brands Are Navigating Amazon’s Latest Compliance Requirements.” Yam covered the past, present, and potential future of Amazon requirements.

He first walked through the process of getting a brand on Amazon through a seller’s point of view in order to highlight the compliance and verification issues that naturally arise during this journey. Yam discussed the certification requirements from 2023, in which sellers needed, for example, to provide a certificate of analysis (COA) to Amazon. However, Amazon’s initial requirements enabled the retesting of a product until it produced a passing result, fabrications of a COA, or calculating the amount of an ingredient in a capsule, rather than actually testing for it. 

In April 2024, Amazon’s requirements were updated to include new information needed from sellers, such as requiring specific contaminants to be tested for, and for all the required product documentation to be funneled through designated laboratories to verify the results, instead of directly through Amazon. “This was a huge wake up call for the brands,” Yam stated. Brands realized ingredients hadn’t been tested for quantity and the validity of manufacturers’ GMP certification was questioned.

He then presented six best practices for navigating Amazon’s latest requirements for today and for the long term:

Use accredited GMP certified manufacturers

Set explicit testing specifications for the product

Conduct third party testing now so issues can be resolved before the inventory leaves the facility

Establish non-compliance protocols with the manufacturing and what the manufacturer will to do to make it right

As a bonus tip, he explained the overlap between products that are NSF certified and compliance with Amazon’s policies.

Next, Yam explained three potential future directions for Amazon compliance:

Mandating that the set of products sent to laboratories for testing come from the Amazon warehouse

Minimizing friction for seller and reduce backlogs

In his CRN Convergence '24 conference presentation, Brian Yam of Blue Ocean Regulatory Inc. discussed how brands can last in Amazon’s marketplace.

Tips for navigating Amazon’s compliance requirements

Sabinsa has announced that its global CEO and managing director, Shaheen Majeed, has been elected the vice chairman of the Confederation of Indian Industry (CII) National Committee on Intellectual Property Rights (2024-25). According to the announcement, CII aims to “create and sustain an environment conducive to the development of India, partnering Industry, Government and civil society through advisory and consultative processes.”

The non-profit, non-government, industry-led-and-managed organization has approximately 9000 members from both the private and public sectors, as well as an indirect membership of more than 365,000 enterprises from 294 national and regional sectoral industry bodies. The organizations National Committee on Intellectual Property Rights is made up of leaders from a range of sectors of Indian industry that recommend policy, educate stakeholders, extend best practices, and organize discussion platforms on intellectual property issues.

“India is progressing in the Global Innovation Index (GII) and is globally viewed as one of the fastest-growing economies in terms of innovation, a testament to cutting-edge technologies and scientific advancements,” said Majeed, in a press release. “CII has consistently supported industries and startups in fostering innovation ecosystem through a strong intellectual property framework. I look forward to collaborating with other committee members and industry peers to devise and drive strategic initiatives that will further industry’s innovation potential.”

Majeed is well-suited for the position of vice chairman, considering Sabinsa’s large intellectual property portfolio of 500 patents. Shaheen himself hold 62 U.S. and international patents, and has authored 31 peer-reviewed publications.

According to the announcement, CII aims to “create and sustain an environment conducive to the development of India, partnering Industry, Government and civil society through advisory and consultative processes.”

Sabinsa’s Shaheen Majeed elected vice chairman of the Confederation of Indian Industry National Committee on Intellectual Property Rights

A growing body of scientific literature has been drawing connections between the health of the gut microbiome and other physiological systems, including brain, skin, and heart health. Emerging research is also pointing to the microbiome’s impact on bone health.

Bones are both structural and serve as a reservoir for minerals such as calcium and phosphorous. These minerals give the bones their “hardness,” while proteins such a collagen give bones “softness,” allowing them to sustain some mechanical pressure without breaking easily.

Cells called osteoblasts are responsible for bone formation by producing collagen, which serve as a scaffold for calcium and phosphorous to deposit into. Osteoclasts are cells that resorb bone, adhering to the bone to dissolve and release mineral deposits. In a healthy system, there is a constant interaction between osteoblasts and osteoclasts. However, when this homeostasis is disrupted, conditions such as osteopenia, characterized by lower-than-normal bone mineral density, or even osteoporosis can occur. This is typically caused by the over activation of osteoclasts, degrading more bone than osteoblasts can rebuild.

Bone mass naturally decreases with age, but bone health is influenced by a number of factors, including nutrition and physical activity. Another potential factor impacting bone mass, researchers are finding, is the microbial composition of the gastrointestinal tract. A dysbiotic gut microbiome has been associated with bone diseases such as osteoporosis. Research has shown that people with osteoporosis have a significantly higher microbiome diversity (in this case, not a good thing), characterized by an abundance of 

. Animal studies have shown that the administration of antibiotics to deplete the gut microbiome was found to restore bone mass.

That said, a healthy functioning gut microbiome does beneficially impact bone health. For example, the microbiome is a source of vitamin K2, required for osteocalcin function and bone formation through the stimulation of osteoblasts. A different animal study also found that a decrease in vitamin K2 levels following antibiotic-induced microbiome depletion was associated with reduced osteocalcin and bone strength in mice.

 Additionally, while antibiotics may reduce the population of detrimental bacteria, they do the same for beneficial bacteria, such as butyrate producing bacteria, which is a short chain fatty acid (SCFA) associated with bone formation.

 For example, antibiotics can cause the depletion of Bacteroidetes. The reduced abundance of this bacteria is also associated with inflammatory bowel diseases and type 1 diabetes, which are populations that experience excessive bone loss.

The gut microbiome can influence bone remodeling both directly and indirectly. For example, the release of microbial metabolites such as SCFAs is one direct mechanism by which the microbiome influences bone remodeling, while indirectly, the gut microbiome can regulate bone remodeling through its interaction with immune cells such as T helper cells 17 or T regulatory cells, as well as hormones such as estrogen.

SCFAs are produced through microbial fermentation of non-digestible dietary fibers. The production of some SCFAs is limited to specific bacterial strains. For example, researchers have linked the production of the SCFA propionate to 

Akkermansia muciniphila, Eubacterium dolichum, Ruminococcus bromii (R. bromii), Bacteroides eggerthii, Bacteroides fragilis

. Butyrate producing bacteria belong to specific bacterial families, namely Clostridiaceae, Eubacteriaceae, Lachnospiraceae, and Ruminococcaceae. Propionate, butyrate, and acetate are SCFAs that have been demonstrated to increase bone mass through inhibiting the production of osteoclasts through a variety of distinct mechanisms.

The gut interacts with the immune system via the intestinal epithelium. Inflammation in the gut can impact the secretion of immune cells. For example, it can result in the production of inflammatory immune phenotypes such as T-helper 17 cells, which produce the proinflammatory cytokines interleukin-17 (IL-17).1 The increase of T-helper 17 cells and IL-17 in bone marrow has been shown to promote bone degradation by stimulating the differentiation of osteoclasts in the bone marrow. On the other hand, T regulatory cells can have a beneficial impact on bone health because of their immunosuppressive functions. Evidence shows that certain microbes can regulate bone remodeling by changing the balance between T-helper 17 cells and T regulatory cells. T regulatory cells work by inhibiting osteoclastogenesis and promoting bone formation through the secretion of anti-inflammatory cytokines, such as IL-4, IL-10, and transforming growth factor-beta.

A recently published study using two large human cohorts identified a potential link between specific bacteria and bone density/strength.5 In the study, researchers investigated the association between the gut microbiome and scans of radius and tibia of two large human cohorts using high resolution peripheral quantitative computed tomography. The cohorts were the Framingham Heart Study (FHS) with 1227 participants between the ages of 32 and 89, and the Osteoporosis in Men Study (MrOS), with 836 participants between the ages of 78 and 98. Results showed that there were 37 microbial genera in the FHA and 4 in the MrOS cohort whose abundance was associated with skeletal health measures.

Meta-analysis of the taxa-bone association found that greater abundance of 

 were associated with lower radius volumetric bone mineral density (vBMD) and tibia cortical vBMD, respectively, while a higher abundance of 

 was associated with greater tibia cortical vBMD. The researchers also observed that there was a great number of bacteria that were negatively associated with bone density but positively associated with bone size, which they speculate could indicate that certain microbes help promote the growth of bones at the expense of bone density as a person ages. While the study finds some interesting patterns, more research is necessary to draw any conclusions about the relationship between specific microbes and bone health. As the body of research grows, the relationship between the gut microbiome and bone health offers exciting new possibilities for product development.

1. Cooney, O.D.; Nagareddy, P.R.; Murphy, A.J.; Lee, M.K.S.Healthy Gut, Healthy Bones: Targeting the Gut Microbiome to Promote Bone Health. 

, 620466. DOI: 10.3389/fendo.2020.620466 

Pytlik, M.; Folwarczna, J.; Janiec, W. Effects of doxycycline on mechanical properties of bones in rats with ovariectomy-induced osteopenia. 

Guss, J.D.; Taylor, E.; Rouse, Z.; Roubert, S.; Higgins, C.H.; Thomas, C.J.; Baker, S.P.; Vashishth, D.; et al. The Microbial Metagenome and Bone Tissue Composition in Mice with Microbiome-Induced Reductions in Bone Strength. 

, 146-154. DOI: 10.1016/j.bone.2019.06.010

Lyu, Z.; Hu, Y.; Guo, Y.; Liu, D. Modulation of bone remodeling by the gut microbiota: a new therapy for osteoporosis. 

Okoro, P.C.; Orwoll, E.S.; Huttenhower, C.; Morgan, X.; Kuntz, T.M.; McIver, L.J.; Dufour, A.B.; Bouxsein, M.L.A two-cohort study on the association between the gut microbiota and bone density, microarchitecture, and strength. 

A look at the science demonstrating the gut microbiome’s impact on bone health.

Healthy bones via the gut

The average maternal age for women in the United States has steadily risen over the past fifty years. According to the U.S. Census Bureau, the average age of mothers reached a record high of 30 years in 2019. For comparison, in 1970, the average maternal age of U.S. women was 24.6 years.

There are many reasons why women are waiting to have children at a later age. Many of these involve education and job opportunities, greater accessibility to reproductive technologies, and the ability to complete certain milestones before starting family planning. Today, 20% of women in the U.S. give birth to their first child after age 35.

The good news is there are multiple benefits for moms when starting a family later, including cognitive and longevity benefits.

The downside is that pregnancies after age 35, or what healthcare practitioners call “advanced maternal age,” come with a higher risk of complications to both mom and baby. Some of these risks include gestational diabetes, preterm birth, increased chromosomal abnormalities and other birth defects, and miscarriage. Risk factors extend to recovery post-birth as well.

The most significant contributing factors to these risks are likely related to ovarian aging, resulting in decreased quality of eggs later in life, and a general increased risk for chronic disease that occurs with age.

Despite these risks, there are various nutritional factors which may help to reduce the risks of pregnancy in women over the age of 35. During pregnancy we know that there is an increased need for essential nutrients like iron, vitamin D, and calcium making nutrition and supplementation increasingly important. Taking a high-quality prenatal vitamin that includes iron, folate, choline, and other nutrients to support a healthy pregnancy at any age is essential.

We’ve known for decades that adequate folate intake prior to conception is important to prevent neural tube defects.

 In addition, emerging data suggests that it may also reduce risk for other fetal structural abnormalities,

 and may help to protect against early delivery, a risk factor with advanced maternal age. Common food sources of folate include dark leafy greens, beans, and peas.

We know that omega-3 is important for fetal brain development for pregnant women of all ages.

 Importantly, there is also some evidence that supplementing with omega-3 fatty acids may help to reduce risks commonly associated with pregnancy after 35, like preterm delivery.

 Food sources of DHA include fish, shellfish, and algae.

Levels of this important antioxidant and energy producing nutrient decrease with age and may also be associated with decreased egg quality and fertility rates. Studies show that supplementing with CoQ10 prior to natural and assisted fertility efforts can help support egg and embryo quality by protecting eggs from oxidative damage.

 Some food sources for CoQ10 include organ meats, fatty fish, and soy.

Supporting insulin sensitivity is important for everyone, but may become increasingly important in advanced maternal age, where there is an increased risk for gestational diabetes. Supplementing with inositol can help to support pregnancy rates, which is a challenge with women over 35.

 Increasing consumption of fruits, veggies, grains, and nuts can help boost choline intake.

Recovering from pregnancy may prove to be a challenge for older women as well.

While age alone may not factor into increased risks, women over 35 may be more prone to other factors that make them more susceptible to post-pregnancy complications like postpartum depression and slow physical recovery. These risks increase dramatically over age 40, and in mothers with multiple births.

In addition to following the nutrient recommendations, keeping up with protein intake, omega-3s, and a quality prenatal or multivitamin with iron and quality B vitamins can help to support recovery time and reduce risk for postpartum depression.

Understanding how women can be best supported and recover from pregnancy later in life is critical for mom and baby as advanced maternal age will likely continue to be more common in the years to come.


Dr. Amanda Frick, ND, LAc is the vice president of medical affairs at Thorne. She leverages her expertise in naturopathic medicine to bring a personalized, science-backed approach to the health and wellness and nutritional supplements space.

US Preventative Services Taskforce. Folic Acid Supplementation to Prevent Neural Tube Defects: US Preventive Services Task Force Reaffirmation Recommendation Statement. 

 (5), 454-459. DOI: 10.1001/jama.2023.12876

Greenberg, J.A.; Bell, S.J.; Guan, Y.; Yu, Y.H. Folic Acid Supplementation and Pregnancy: More Than Just Neural Tube Defect Prevention.

Obeid, R.; Holzgreve, W.; Pietrzik, K. Folate supplementation for prevention of congenital heart defects and low birth weight: an update. 

 (Supp 2), S424–S433. DOI: 10.21037/cdt.2019.02.03

4. Devarshi, P.P.; Grant, R.W.; Ikonte, C.J.; Mitmesser, S.H. Maternal Omega-3 Nutrition, Placental Transfer and Fetal Brain Development in Gestational Diabetes and Preeclampsia

Xu, Y.; Nisenblat, V.; Lu, C.; Li, R.; Qiao, J.; Zhen, X.; Wang, S. Pretreatment with coenzyme Q10 improves ovarian response and embryo quality in low-prognosis young women with decreased ovarian reserve: a randomized controlled trial. 

Zheng, X.; Lin, D.; Zhang, Y.; Lin, Y.; Song, J.; Li, S.; Sun, Y. Inositol supplement improves clinical pregnancy rate in infertile women undergoing ovulation induction for ICSI or IVF-ET. 

 (49), e8842. DOI: 10.1097/MD.0000000000008842

How we can better support preparation and recovery in a population of new (older) moms. 

Pregnancy over 35

In the U.S. alone, more than 2 million women every year reach menopause. That translates to about 6,000 women daily. If you count 81 years as the average life expectancy, as the Mayo Health System does, women spend more than one-third of their lives in the three stages of menopause: perimenopause, menopause, and post-menopause.

Perimenopause–when a woman’s ovaries start producing less estrogen and progesterone leading to fewer and irregular monthly periods–often starts to affect women in their early to mid-40s; however, some women show signs as early as their 30s.

After 12 months of a woman going without having her period, she is officially in menopause and can no longer become pregnant. This is followed by post-menopause, which lasts the remainder of a woman’s life.


Symptoms tend to be fewer and more mild during this period, but for some, they remain a significant challenge to their health and well-being.

As we hear (too often these days) from political pollsters, demographic groups are not monoliths when it comes to voting; the same can be said about women going through the change of life.While they may experience similar symptoms during all three stages of menopause, the manifestation of those symptoms can vary from woman to woman in intensity, effects, and duration.

There is some good news, however, that goes beyond those physically exhausting, emotionally draining, and psychologically challenging symptoms. For example, some experts say the way our society looks at this time in a woman’s life is changing for the better.

Komal Baldwa, founder of India-based Waleria Healthtech, believes that “the perception of menopause has significantly evolved in recent years, but there is still a long way to go in addressing the gaps that remain from past neglect of women’s health. This evolution can be seen across various groups, although the pace and depth of change differ.”

The shift among consumers is remarkable, she says. “Women are becoming more empowered, seeking knowledge, and advocating for their health. Online forums and support groups are fostering self-education, and women are turning to alternative therapies and solutions.”

Izaskun Monsalve, PhD, global marketing manager for women’s and infant health, proactive health at Kerry Group (Tralee, Ireland), concurs. “In recent decades,” she says, “society has made significant strides in empowering and emboldening women to seek out the lives they want for themselves.”

However, Monsalve adds, “While women should be able to navigate life’s cycles with as much ease and clarity possible, there’s still work to be done.”

The demand for more comprehensive and accessible menopause care is growing, states Baldwa, and it’s “women who are driving this momentum, leading the charge and shifting the narrative around menopause.”

Herein lies an opportunity for the women’s health category for ingredients and dietary supplements, particularly for those companies committed to providing scientifically backed solutions.

Monsalve points out that “Women, and those who care for them, are eager for solutions that can bolster their health and allow them to live life to the fullest. As Kerry research has shown that 8 out of 10 consumers throughout the world have consumed supplements in the last year, it is the most direct way to provide positive health benefits to the masses.”

Further, Baldwa notes that “studies show that 77% of women remain hesitant to use hormone therapy despite experiencing menopause-related symptoms. With an increasing number of women seeking natural, non-pharmaceutical alternatives, the industry must develop effective, safe, and validated products.”

For example, she adds that “many women prefer non-hormonal options for symptom management, and ingredients like black cohosh, Shatavari, and omega-3s offer natural alternatives that support holistic health.”


It seems like common sense—the healthier you are throughout your life, the healthier you will be as you go through the change of life.

As Monsalve explains, “Before, during, and after menopause are all times of great change in a woman’s body, and therefore life. Naturally, women have become more interested in a proactive approach to wellbeing with a focus on prevention, as 75% stated that they are adopting a long-term health plan.”

She suggests that by taking steps to prioritize wellbeing, women can set themselves up for success not just at their annual checkups, but year-round. “Early attention to the immune system, eyes, brain, and hormonal health through supplements and diet are easily accessible steps that can alleviate heath issues later in life,” says Monsalve.

“At Kerry,” she says, “we encourage and help women to take ownership of their own menopause journey and make informed decisions that can have long-lasting positive effects on their health, and we provide products which can help through this important life-stage. Taking charge and adopting proactive practices for all around health, like incorporating supplements into daily routines, can ease these years that have traditionally been painful for women.”

Some of the more common and most complained about symptoms that occur during menopause are hot flashes, night sweats, fatigue, anxiety, and insomnia.

Fortunately, there are a number of natural, branded ingredients available in dietary supplement products for women to combat these symptoms.

One ingredient for relief from common menopausal symptoms is Libifem, a branded fenugreek extract from Gencor Pacific (Austin, TX).Maggie McNamara, vice president of global marketing for Gencor, pointed to a published study, funded by Gencor Pacific (who also supplied the investigational products), in which the standardized 

 de-husked seed showed what she said were “excellent outcomes to support [the reduction of] hot flashes and night sweats.”

The double-blind, randomized, placebo-controlled clinical trial was conducted in a cohort of healthy women, aged 40-65, either perimenopausal or menopausal, who were experiencing symptoms such as hot flushes, night sweats and other related symptoms. Among the findings, the study authors noted that “over the study period, a gradual significant reduction (approximately 50%) in total flushes was observed in the active treatment group (p < 0.001),” leading them to suggest that the proprietary treatment ingredient was “an effective treatment for reducing vasomotor symptoms and associated menopausal symptoms in otherwise healthy women.”

First introduced to the European market five years ago, Kerry’s branded ingredient, Luprenol, with 8-Prenylnaringenine (8-PN), is a scientifically backed phytoestrogen ingredient that has been demonstrated to safely combat these symptoms, offering relief through menopause, says Monsalve. She explains that “in a clinical study on the active ingredients in Luprenol, specifically 8-PN, one of the strongest known phytoestrogens, women who took the solution experienced a 40% reduction in hot flashes and a 32% improvement in symptoms of nervousness, fatigue, and excessive sweating.” 

This past April, Waleria announced the results of a new study investigating its aspurūs Shatavari root extract for the management of menopausal symptoms and regulation of hypothalamic-pituitary-ovarian (HPO) axis.

The 8-week, prospective, randomized, double-blind, multi-center, placebo-controlled study enrolled 70 participants split between a test group receiving aspurūs Shatavari root extract and a placebo group. The participants were pre-and post-menopausal women between the ages of 40-65 years old who were experiencing menopausal symptoms such as hot flashes, night sweats, anxiety, fatigue, and mood swings. The primary outcome measure was the total score of Utian Quality of Life (UQoL).

The study results revealed reductions in the test group compared to placebo in symptoms such as hot flashes, night sweats, anxiety, fatigue, and insomnia. Regarding the UQoL scores, improvements were significant in the test group indicating a tangible enhancement in overall well-being. When compared to placebo, the test group saw an 85% reduction in hot flashes in as few as 4 weeks, a 90% reduction in night sweats in 8 weeks, and 60% greater reduction of reported sleeplessness.

“The findings demonstrate compelling evidence of the efficacy of aspurūs in supporting menopausal symptoms and enhancing overall quality of life,” said Danielle Greenberg, research consultant at Waleria Health, in a press release. “The significant reductions in hot flashes and night sweats coupled with the notable improvements in Utian Quality of Life scores show the potential of aspurūs to offer meaningful relief for women experiencing menopausal transition.” 

Bone Health is Foundational During Menopause

Most often when we think about peri- and menopausal symptoms, it’s the one’s that give the “ick factor”—the night sweats, the hot flashes, the mood swings, the vaginal dryness—that are most often associated with the hormonal changes.

However, there are other symptoms that can be serious too. For instance, strong bones are foundational to a healthy body, and it’s no secret that aging makes us more prone to bone loss and bone breakage.According to Jennifer Gu, PhD, vice president, research and development at AIDP (City of Industry, CA), “It is well-known that menopausal women lose bone density at an accelerated rate. In fact, bone fractures are a major concern for aging women.”

One of AIDP’s foundational branded ingredients, KoAct, has been on the market for around 15 years, supported by clinical research and three U.S. patents for its unique composition as well as its application in improving bone mineral density and bone strength, according to Gu. She explains that the formulation “goes beyond calcium supplementation and other general bone supplements by providing calcium and bone collagen at the same time.”

In the ingredient’s earlier years, AIDP, Inc. funded the first long term-clinical trial to directly compare the effects of calcium collagen-chelated products (KoAct) to calcium and vitamin D in postmenopausal females. The 12-month, randomized controlled trial studied 39 postmenopausal women divided into two groups, one group taking calcium-collagen chelate, the other, a capsule mix of calcium and vitamin D. 

The study was led by Bahram H. Arjmandi, PhD, RDN, an internationally recognized expert in nutritional interventions for bone health and other health conditions. The investigation found that “the group taking the calcium-collagen chelate, saw a loss of 1.23% in bone mineral density, while the control group saw a 3.75% loss.”

Further, Dr. Arjmandi commented at the time “that supplementation with KoAct may provide protection against bone loss and increased bone turnover for which supplementation of calcium and vitamin D alone could not achieve.” The study was published in the 

Hair, Skin and Nails Still Matter in Menopause

If it seems vanity-based only, consider that thinning hair, dry skin, and brittle nails can add to diminished confidence and emotional distress for menopausal women already dealing with other issues that may challenge their feelings of femininity.

Earlier this year, AIDP announced results from a randomized, double-blind, placebo-controlled study published in the 

 on the effects of Keragen-IV oral supplementation on hair and skin. Although the study was not specifically conducted in menopausal women, the age range of 45-60 may give women in the change of life some hope.

The 60-day trial studied 65 females with healthy skin and damaged or stressed hair, receiving either the keratin-based formulation (Keragen-IV), or placebo. At the end of the trial, the Keragen-IV group experienced significant improvements in reduced hair loss (43%) as well as a 17.61% improvement in the birefringence of the hair cortex, compared to placebo. These results suggest that the functional ingredient that shares homology with keratin naturally present in human hair may increase the structural integrity of the hair cortex in as little as 60 days.

As for skin health, there were also some positive results. The treatment group saw a significant 10% increase in comparison to the placebo group in gross skin elasticity after 60 days. In addition, there were improvements in skin barrier function with oral Keragen-IV, after 30 days, measured by 12.5% lower levels of trans epidermal water loss, a non-statistically significant improvement when compared to placebo.

AIDP’s Gu served as one of the principal investigators in the trial. She stated, in part, that “this study verifies Keragen-IV’s role in hair anchoring which is a concern for many women experiencing hair loss due to hormonal changes or stress.” 

Putting Women at the Forefront of Research

Waleria’s Baldwa is energized by what she is seeing from the research community where, she says, “institutions like the University of Melbourne are leading the way with innovative approaches, such as focusing on preventive strategies and understanding menopause as a natural life stage rather than a medical condition to be treated.”

What’s more, she says that this signals a shift towards a more proactive and holistic approach. She points to the University of Leeds which she states “is known for its research into menopause, particularly in workplace support and the socio-economic impacts of menopause. Their work often highlights the importance of accommodating menopausal women in the workforce.”

Gencor has long been an advocate for studying ingredients in female (and male) populations and McNamara says that “one of the most pressing areas for advancement in the industry is the focus on female-only populations in clinical research.”That’s because, as she explains, “the biological differences between males and females are well-documented, and how ingredients are metabolized can be significant. For example, hormonal fluctuations, differences in body composition, and variations in metabolism can all play pivotal roles in the efficacy of natural products.”

She advocates that “this targeted approach is critical and necessary to understand better how functional ingredients can safely and effectively benefit female physiology. It also enables brands to develop supplements tailored to women’s unique needs rather than repackaging ingredients previously only studied in male physiology.”

Baldwa also finds it crucial for women to continue to speak out, especially openly discussing their menopausal symptoms and the need for relief. In that way, she says that “women can normalize menopause as a natural life stage, encouraging others to share their experiences, seek help, and prioritize their health.”

This is the kind of personalized advocacy that Baldwa believes can also drive medical research into underexplored areas like cardiovascular, mental, and bone health for women.

She adds that it is also “our responsibility [as an industry] to maintain that trust [sought] out by women, by investing in new research and collaborating with healthcare providers. This ensures that our products complement other treatments and contribute to more integrated care.”

Kerry’s Monsalve, too, believes that “it’s imperative that the industry as a whole fully recognize menopause as a global health issue, guiding women through options to optimize their own health.”

Judy Blatman Communications LLCspecializes in writing for industry publications and clients, strategic counsel, and media training. Ms. Blatman spent 16 years as SVP, Communications, Council for Responsible Nutrition.

1. Pausing to learn more about menopause. 

https://www.mayoclinichealthsystem.org/hometown-health/speaking-of-health/too-embarrassed-to-ask-part-3

Steels, E.; Steele, M.L.; Coulson, H.S. Efficacy of a Proprietary Trigonella foenum-graecum L. De-Husked Seed Extract in Reducing Menopausal Symptoms in Otherwise Healthy Women: A Double-Blind, Randomized, Placebo-Controlled Study. 

From hot flashes to mood swings, menopause is rough on women, and they are actively seeking out solutions.

Univar Solutions

Articles

Latest Updated Articles