“Testosterone exerts multiple effects on the body, and libido/anabolic effects (where the market started) are not necessarily the most important ones,” says Gencor’s Paul Clayton.
Photo © Shutterstock.com/Dean Drobot
“Low T,” a term popularized by commercial tv, has become one of the most successful modern ad campaigns for men’s health. If you believe those “Low T” commercials, the inability to produce sufficient levels of testosterone (a condition also known as hypogonadism-or, in the case of lower production related to natural male aging, as andropause) is likely responsible for a number of men’s present-day health woes, with decreased energy and suboptimal libido among the most advertised.
Research focus around testosterone is gradually moving beyond just energy and libido alone. According to those specializing in the men’s dietary supplements market, attention around testosterone support may be slowly-slowly-extending to the role that healthy testosterone levels play in areas less sensational, but nevertheless extremely important, to male health overall.
Paul Clayton, PhD, chief scientific advisor to ingredients firm Gencor (Irvine, CA), describes the evolving interest in testosterone support. “Interest in testosterone fell back a little after the initial articles (e.g., see TIME magazine’s “Manopause?!” cover from August 2014), but then stabilized and has recently seen an uptick due at least in part to the publication of various scientific articles showing that low testosterone is bad for men’s health in a variety of ways, and that returning testosterone in low-testosterone males to physiological levels does not cause adverse effects.” He continues, “Male performance is still interesting to a section of the market and likely always will be, but now we see a larger number of men who are more interested in improving their general well-being.”
And, increasingly, science continues to support the notion that testosterone does play an important role in general well-being. As Clayton says, “Testosterone exerts multiple effects on the body, and libido/anabolic effects (where the market started) are not necessarily the most important ones.”
Testosterone, for instance, is intrinsic to men’s bone health. In a recent International Journal of Endocrinology paper1 reviewing the link between testosterone deficiency and bone structure, researchers explained, “Testosterone has a clear, direct effect on bone health. Testosterone signaling stimulates osteoblasts to form trabecular bone and helps osteocytes prevent trabecular bone loss. This leads to the decreased [bone mineral density] and increased fracture risk seen in men with both primary and secondary hypogonadism.”
Testosterone is also increasingly being noted as important to heart health and brain health, Clayton says. It’s a theory supported by ongoing research2,3. “This trend is likely to increase,” he adds, “as recent work at the University of California, Los Angeles, has shown that restoring testosterone in middle-aged and elderly males is also neuro-protective and likely to find a role in protecting against dementia.”
Emerging markets like bone, brain, and heart health are certainly areas where dietary supplement companies will want to lay their bets in the future. For the present time, however, dietary supplement makers report still seeing most success in the market-proven categories of testosterone supplementation-namely, sexual health. Ahead, we take a look at some of the ingredients with new science in this area.
Sexual Health and Vigor
Fenugreek (Trigonella foenum-graecum) remains a leading ingredient in the sex-health category. Gencor’s branded fenugreek ingredient, Testofen, is said to increase energy, sex drive, and general feelings of well-being. Clayton describes how Testofen works to raise testosterone levels.
“There are at least two mechanisms,” he says. “I should start by making it clear that Testofen is not a testosterone analogue, but it has been shown to increase free testosterone levels by dislodging a fraction of testosterone in the bloodstream that is bound to serum albumen [a protein in the blood] and hence inactive. This is a novel and very interesting mechanism, which you can describe as ‘re-partitioning.’”
The second way in which Testofen and its active constituent-furostanolic saponins-work, he says, is by inhibiting the enzyme 5-alpha-reductase. In doing so, he says, “this second mechanism not only increases free testosterone but also reduces dihydrotestosterone (DHT) in some tissues, providing a second benefit-namely, the alleviation of benign prostatic hyperplasia.”
The company’s latest study4 published on Testofen backs its testosterone-raising effects. Published in the journal Aging Male last year, the double-blind, randomized, placebo-controlled study was conducted in 120 healthy middle-aged men between the ages of 43 and 70. Researchers found that subjects who took 600 mg/day of Testofen for 12 weeks saw a significant increase in the Aging Male Symptom questionnaire (AMS), a measure of possible androgen deficiency symptoms-that is, low levels of testosterone.
Testofen subjects also saw improvements in sexual function and serum testosterone (both total serum testosterone and free testosterone), leading researchers to conclude that “Trigonella foenum-graecum seed extract is a safe and effective treatment for reducing symptoms of possible androgen deficiency, improves sexual function, and increases serum testosterone in healthy middle-aged and older men.”
According to Clayton, “This trial showed, for the first time, that the negative symptoms of the viropause,” another word for andropause, “could be effectively managed using a safe and botanical product.”
Ingredients supplier Cepham (Piscataway, NJ) also offers a proprietary Trigonella foenum-graecum extract under the brand name Furosap, which has been shown to boost healthy testosterone levels, sperm profile and morphology, sexual health, mood, and mental alertness in humans, the company says.
The ingredient is standardized to contain key testosterone-boosting constituents (45% furostanolic saponins and 20% protodioscin). “These chemical constituents act synergistically to promote healthy free serum testosterone levels, as demonstrated by our human clinical studies,” says Debasis Bagchi, PhD, Cepham’s chief science officer.
The most recent study5 on Furosap was published this year in the International Journal of Medical Sciences. The 90-day, one-arm, open-label multicenter study was conducted in 50 male volunteers ages 35 to 65. Subjects were given 500 mg of Furosap daily.
Researchers found that free testosterone levels improved by up to 46% in 90% of the study population. Also during the study, 85.4% of the study population showed improvements in sperm counts, with sperm morphology improving in 14.6% of volunteers.
The study findings also extend to other areas of testosterone interest, with researchers noting improvements not only in libido but also in mental alertness and mood in a majority of the subjects, as well as improvements in cardiovascular health.
Overall, the researchers concluded, “the results demonstrate that [Furosap], enriched in 20% protodioscin, is safe and effective in attenuating testosterone levels, healthy sperm profile, mental alertness, cardiovascular health, and overall performance in human subjects.”
In addition to Furosap, Cepham is now supplying BlaMus, a black-musli extract (Curculigo orchioides). The company says it has animal data showing that BlaMus may help boost testosterone levels.
In a recent rat study, researchers found that a 50-mg dose of BlaMus effected significant increases in serum free testosterone after 28 days of supplementation (but no significant increases in serum total testosterone levels). “These data demonstrated that BlaMus may serve as a safe and novel natural testosterone booster and provide broad-spectrum applications in sports nutrition, muscle building, and exercise pathophysiology,” researchers concluded. Cepham says the study (Chopra K et al., “Safety and free testosterone boosting efficacy of a novel Curculigo orchioides extract in male rats”) will soon be published in The FASEB Journal.
HP Ingredients (Bradenton, FL) is another company whose ingredient-LJ100, a studied tongkat ali (Eurycoma longifolia) extract-is assisting men with flagging libido. Standardized to 40% glycosaponins, more than 22% eurypeptides, 30% polysaccharides, and 1% eurycomanone, the ingredient is patented for its ability to combat sexual dysfunction and male infertility. The company says LJ100 is extracted using patented technology that the firm describes as a high-temperature, high-pressure, reverse-osmosis water extraction method.
In the ingredient’s most recent study6, in 2014, researchers found that LJ100 (which also markets under the trade name Physta by the company Biotropics Malaysia) was effective in enhancing sexual performance in healthy male volunteers in combination with another Malaysian herb, Polygonum minus.
The 12-week, randomized, double-blind, placebo-controlled, parallel-group study was conducted in 26 men aged 40-65 years. The supplementation group received a 300-mg combination of LJ100 and Polygonum minus. Outcomes were measured via validated questionnaires evaluating erectile function, satisfaction, sexual intercourse performance, erectile hardness, mood, and overall quality of life.
“The LJ100 group demonstrated statistically significant higher scores than the placebo group in the following endpoints: Erection Hardness Scale score, Aging Males’ Symptom score, and the Sexual Health Inventory for Men,” says Annie Eng, CEO of HP Ingredients.
HP Ingredients isn’t just promoting this ingredient for sexual health, either. The company says it has evidence (published and unpublished) showing the ingredient has an ability to increase energy, enhance sports performance, increase fat-free mass, improve mood state and maintain healthy cortisol levels7, and support healthy immunity.
Focus on Energy/Sports Nutrition
Aside from sex health, testosterone boosters are, of course, famous for increasing energy and supporting muscle mass.
“Energy and better maintenance of musculature are two predominant areas of health that benefit from increasing testosterone,” says Chase Hagerman, brand director for ingredients firm Chemi Nutra (Austin, TX). “Lesser-known benefits of testosterone include aiding in recovery following exercise.”
Hagerman says early data8 from a sports-related study indicate that his company’s SerinAid phosphatidylserine ingredient may help to “normalize” healthy testosterone levels in men.
“In addition to age-related testosterone impairment, testosterone levels can be decreased from physical stress like that of exercise,” he says.9 He notes that “phospholipids in general, and here phosphatidylserine, are involved in the hypothalamic-pituitary-adrenal (HPA) axis, as is cortisol and testosterone.”
Jeff Lind, vice president, sales and marketing, for ingredients firm Natreon Inc. (New Brunswick, NJ), says his company is focusing on how testosterone’s anabolic effects also relate to muscle mass and strength, supporting a growing role for testosterone-supporting products in the heavy-hitting sports nutrition market. (Gencor’s Clayton points out that testosterone’s role in muscle building also lays ground for a role in combatting sarcopenia, or age-related muscle mass.)
“The testosterone market is extremely large, as it plays a significant role in both the men’s health/sexual health segment as well as the sports nutrition segment,” Lind says. Given the continued growth of both the sexual health and sport nutrition markets, he says, “you can see that the testosterone market is healthy and growing.” During the Natural Products Expo West trade show this March, Nutrition Business Journal reported 7.8% and 7.1% year-over-year growth in 2016 of U.S. sports/energy/weight loss and sexual-health supplements sales, respectively-healthy growth indeed.
In fact, in a sort of reversal, Lind’s company, Natreon, is now proposing one of its ingredients originally targeting the sports nutrition and antiaging market for the male sexual health market. The ingredient is PrimaVie, made from purified Himalayan shilajit, an ingredient used in Ayurvedic medicine. As Lind says, “PrimaVie increases both total and free testosterone in oligospermic [low sperm] subjects as well as in healthy volunteers. Additionally, PrimaVie increases mitochondria, energy, and improves endothelial function.”
In 2016, a 75-subject, randomized, double-blind, placebo-controlled study10 published in the journal Andrologia. The study was performed in healthy male subjects. Researchers found that 250 mg of PrimaVie twice daily for 90 days increased total testosterone, free testosterone, and dehydroepiandrosterone compared with placebo. According to Lind, “This study, along with the previous study11 in oligospermic males as well as the performance-in-exercise study of healthy volunteers, positions PrimaVie as a leading dietary supplement ingredient for male sexual health as well as sports performance.”
And, further coming back to the concept of overall well-being, Lind says that a recent study12 published in the Journal of Medicinal Food showed that PrimaVie “upregulates the genes responsible for collagen synthesis, making PrimaVie an excellent ingredient in healthy-aging formulations” as well.
As of now, interest in testosterone-supporting ingredients continues to keep the men’s supplement industry on a straight course. “Based on our experience, we would say the interest in testosterone-supporting supplements has been steady for the past five years-that is, there has been no notable increase, but no decrease either,” says Chemi Nutra’s Hagerman. “Perhaps the most prominent change has been the increase in products that have become market leaders in this category.”
In the long term, Gencor’s Clayton says, shifting attention away from “sensational” positioning and moving toward an overall-health-benefits positioning may in fact be good for the supplement category; for, while it means the increase in product sales may not be as “sensational” as they once were following the “Low T” hype, sales may ultimately be more sustainable down the road.
Testosterone support will always remain a key focus of the men’s supplements market, of course. After all, Hagerman points out, “you could argue it is the only health focus that differs from women’s health.” As such, he says, “testosterone support is certainly one of the essential focuses of health that makes up the men’s health category.”
How that focus around testosterone continues to evolve remains to be seen, but one thing is for sure: its importance to overall male health can’t be underestimated. “Testosterone has versatile functions,” says Cepham’s Bagchi. “It plays a major role in prenatal development, as well as development of brain, prostate glands, and sex organs. During childhood, testosterone is instrumental in developing brain, hair, and muscle. During adulthood, testosterone plays an important role in sperm development and sexual health.”
Eng of HP Ingredients adds that all of the commercial advertising may in fact have helped men feel more comfortable in ultimately seeking out dietary supplements to support drops in libido. Giving the condition a name like “Low T,” she says, “eases the discomfort or embarrassment previously associated with age-related declines in testosterone (the idea of losing one’s virility or masculinity).”
“The current generation of middle-aged men does not appear at all to be embarrassed because they are overall more aware and understand that their sex hormone levels tend to decline-naturally,” she says, “and, therefore, they are more willing to try products that help them regenerate their own testosterone-producing mechanism,” such as the array of supplements waiting to serve them.
We Can…But Should We?
Age-related testosterone declines are a normal part of the aging process for men. Critics of today’s testosterone-boosting marketplace argue that instead of using supplemental products to elevate testosterone levels, we should let those declines happen as nature intended. We asked those we interviewed for this story: If declining testosterone levels are a normal part of male aging, should we-either through dietary supplementation or drug/treatment interventions-be attempting to restore testosterone levels to youthful levels? Here are their responses:
Chase Hagerman, brand director for ingredients firm Chemi Nutra (Austin, TX): “Absolutely. Testosterone, libido, and lean body mass aside, I think most people would agree that more vitality is a welcome thing.”
Annie Eng, CEO of HP Ingredients (Bradenton, FL): “Absolutely. ‘Younger’ levels of testosterone promote healthy outlook via improved or sustained quality of life. Everything in healthy moderation, and that includes dietary supplements such as LJ100; we do not advise our marketing partners to print dosages more than 600 mg per day for men.”
Paul Clayton, PhD, chief scientific advisor to ingredients firm Gencor (Irvine, CA): “This is a profound question and goes to the philosophical heart of modern medicine. There are multiple answers. To begin, how natural is the aging process as it is experienced today? The answer is that it is not natural at all. For example, studies done in the so-called ‘Blue Zones’ [parts of the world where people live the longest] show that the diseases we think of as age-related (heart disease, cancer, dementia, osteoporosis, etc.) do not occur at anything like the rates we see in our society, and are not so much to do with aging per se as the profoundly toxic aspects of the modern lifestyle and the resulting burden we carry of chronic inflammation. Then, if we take another tack, how natural is it to use modern technologies ranging from immunization to dentures and glasses, to motor cars and jet airplanes, to freezers and microwave ovens? There is change, and there is progress, depending on your own values and definitions.
But if we revert to an overall health perspective, the case is simpler. Restoring testosterone levels in males with sub-normal levels makes them feel better and is associated with multiple health benefits. And there is a time-specific factor that should be considered here-namely, very good evidence published last year that male testosterone levels are falling and are probably linked to the very significant increase that has been recorded in male sub-fertility and infertility. This is probably due to the same toxic lifestyle factors that have made us so vulnerable to the ‘diseases of civilization,’ and so the debate about what is natural and what is not natural becomes very complex.”