Perimenopause is the next needed women's health category

[EDITOR'S NOTE: This feature is just the tip of the iceberg of industrial know-how to address the burgeoning women's supplements category. To learn more about postmenopause, how to market to women, 12 must-use supplement ingredients for your formulation, and the "microgenderome," download the free Natural Products Insider digital magazine here.]

“Well, sh**,” I thought to myself as I realized perimenopause was taking over my body. 

I was on the cusp of turning 45, with a full life and a seemingly normal amount of stress, but I wasn’t sleeping well and I was noticeably more anxious. After waking up from a night sweat, I suddenly understood I was facing the inevitable. 

Fast-forward a couple weeks and I had my first true hot flash while awake. A checkup with my gynecologist confirmed my suspicions — I was entering the phase of life known as perimenopause. Having researched nutraceutical ingredients for many facets of women’s health, my professional work suddenly took on a very personal meaning. 

The predicament with perimenopause — No one talks about it! 

I was not prepared for this! But I’m not alone — in fact, more than 90% of women never received any education about menopause in school, according to results from a recent online survey. Additionally, 60% did not feel sufficiently informed about this natural transition. 

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Jean Marino, APRN-CNP, MSCP, IF, a women’s health nurse practitioner at University Hospitals in Cleveland, agreed. “I saw a gigantic need — not only for education, but treatment for both perimenopause and menopause,” the specialist in menopause and women’s sexual health shared. “It is a time of huge fluctuations in hormones that impact everything.” She noted classes are commonly offered about puberty and childbirth, but very little education exists for women about menopause and the accompanying changes. 

While perimenopause is considered a normal life event, taking medications or supplements is not about its treatment — rather, addressing unpleasant symptoms accompanying the transition. 

“Women have estrogen receptors everywhere, so everything is impacted by the fluctuating hormones,” Marino maintained, adding that vasomotor symptoms are the most familiar earmark of perimenopause. She said many women are surprised to learn that other symptoms, like changes in mood, are quite common, and that many women can have unique issues like lack of energy, fatigue and low self-esteem. 

“All right, Devon, time to get to work...”  

Most ingredients for perimenopause aim to help balance hormones or address mental health. Many recent studies — specifically in perimenopausal women — evaluate the benefits of nutraceutical ingredients. Let’s explore some of them. 

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ISO ingredients for perimenopause — isoflavones? 

I learned a great deal about soy isoflavones in grad school, so phytoestrogens became my starting point for perimenopausal ingredients. The research has since come a long way. For instance, Menopause: The Journal of The Menopause Society, published a meta-analysis on the effects of soy isoflavones on hot flash frequency and severity. However, soy is not the only source of phytoestrogens — isoflavones also are present in red clover (Trifolium pratense). 

In one study on red clover, isoflavones were subjected to cold fermentation with a proprietary mix of lactic acid bacteria cultures, and were evaluated for their impact on vasomotor symptoms versus a placebo in 59 perimenopausal women over a span of 12 weeks. Supplementation with the red clover isoflavones significantly reduced hot flash frequency and intensity after three months as measured by both skin conductance and self-reported results. 

While no changes in cholesterol were noted in the previous study — presumably because parameters for all subjects were within normal range — red clover has been shown effective in reducing total cholesterol, according to a meta-analysis of studies conducted on perimenopausal and postmenopausal women. This is quite noteworthy, as hormonal changes during perimenopause can significantly impact cholesterol levels. 

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I’m just mad about saffron… 

Saffron (Crocus sativus) extracts have become increasingly popular for their positive effects on mental health — I recently utilized saffron in a gummy formulation supporting sleep and relaxation. A study from Mashhad University of Medical Sciences in Iran evaluated the effect of saffron stigma extract in combination with fennel seed and chamomile flower extracts on perimenopausal symptoms in 120 women. Subjects received either a placebo, low dose (250 mg chamomile, 30 mg fennel, 15 mg saffron), medium dose (500 mg/60 mg/30 mg) or high dose (1,000 mg/120 mg/60 mg) for 12 weeks and filled out a questionnaire at baseline and weeks one, six and 12. Both the medium and high doses showed significant symptom reduction in physical, psychological and urogenital symptoms. 

Another study out of Murdoch University in Australia evaluated the effects of 14 mg saffron extract alone (as affron, from Pharmactive) twice daily in 86 perimenopausal women over a period of 12 weeks. Three surveys and scales were used to measure changes in physical and psychological symptoms. While saffron did not show any improvement in vasomotor or somatic symptoms compared to the placebo, researchers observed significant reductions in anxiety and depression symptoms. 

Tongue-tied about tongkat ali 

Tongkat ali, also known as Eurycoma longifolia or Malaysian ginseng, is another botanical ingredient touted for positive impact on mood. What I found most interesting about this ingredient is not only has it been studied in perimenopausal women, but it also has been shown to improve testosterone levels and sexual performance (in conjunction with Polygonum minus) in men. 

A study on 75 perimenopausal and menopausal women in Canada evaluated the effect of 100 mg daily supplementation with tongkat ali (as Physta, from Biotropics) and 400 mg Labisia pumila (SLP+) extracts (marketed as Nu Femme, from HP Ingredients) over 24 weeks. Although the study reported a significant placebo effect — which the authors stated is common in menopausal clinical trials — supplementation with the botanical ingredients significantly reduced follicle-stimulating hormone, which normally increases in women undergoing perimenopause. Both test and control groups showed significant reduction in hot flashes, although the percentage of those reporting a reduction was higher for the group receiving Nu Femme. 

A protocol for a clinical trial studying the effects of tongkat ali alone was published last year, with the anticipation that data collection would be completed in December 2023. The study will investigate two doses of 50 mg and 100 mg versus placebo over 12 weeks in perimenopausal and postmenopausal women. 

Press play: Perimenopause is manageable 

Clearly an array of ingredient options may help alleviate the unpleasant symptoms of perimenopause. Of course as product formulators, we must consider regulatory issues and organoleptic challenges as we create new functional foods and supplements. Thankfully, many ingredients are GRAS (generally recognized as safe) for several food and beverage applications, and others have “old” dietary ingredient status for use in supplements. Flavor masking technology has made great strides that eliminate most issues in formulating with botanical ingredients. 

It’s an exciting time to be in the nutraceutical industry and it is an exciting time for women’s health. The more we speak out about perimenopause, the more we can normalize discussions and get the industry to take notice, leading to more product options for women around the globe. Let’s do this!