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   Jun 22

Prostate Health Ingredient Research, From Tea to Cranberry

  • ORIGINAL ARTICLE: http://www.nutritionaloutlook.com/herbs-botanicals/prostate-health-ingredient-research-tea-cranberry

Tea Time, with Prostate Benefits

Emily Fritz, technical service manager at Kemin (Des Moines, IA), says that her company is continually working to better communicate the benefits of its branded and patented tea-based prostate health ingredient, AssuriTea. For the last year, she says, Kemin’s approach to the men’s health space has been to continue educating the public about its existing line of products. “Consumer demand for natural products is increasing,” Fritz says, “which is why we’ve stepped up our marketing of AssuriTea. That’s where most of our energy has been spent when it comes to men’s health.”

A proprietary blend of water-extracted green and black tea (Camellia sinensis L.), AssuriTea is designed to reduce lower urinary tract symptoms (LUTS) in men and improve urinary function. One randomized, double-blind, placebo-controlled clinical trial of AssuriTea followed 46 men between the ages of 30 and 70 who scored at least 8 on the American Urological Association Symptom Score (AUASS) test. Participants were randomized to receive either 500 mg of AssuriTea, 1 g of AssuriTea, or placebo, for 12 weeks. This trial found that taking 1 g of AssuriTea per day for 12 weeks caused a statistically significant increase in urine flow relative to a placebo and improved symptoms of LUTS.1

A second randomized, double-blind, placebo-controlled clinical trial funded by Kemin examined the effects of AssuriTea on antioxidant concentrations in 43 healthy men between 25 and 70 years of age. Participants were randomly assigned to a placebo or to 250 mg, 500 mg, or 1 g of AssuriTea for 28 days. The study found that a daily 1-g dose of AssuriTea resulted in a statistically significant improvement in cellular antioxidant protection after 28 days relative to the placebo.2

Fritz notes the significance of these antioxidant findings: “Prostate health issues are often caused by or exacerbated by inflammation and oxidative stress. That’s why AssuriTea provides both the anti-inflammatory benefits of black tea and the antioxidative benefits of green tea.”

AssuriTea is targeted at the active lifestyle consumer, Fritz says, noting that Kemin’s men’s health ingredients fall under the umbrella of active wellness. She says this is no accident: marketing prostate health products, she says, often requires a circuitous approach.

“[Prostate health] is something that a lot of men aren’t comfortable talking about, and a lot of household purchasers are female. So, our marketing campaign last year focused on the overall health and well-being angle,” she says. “We talked about how a healthy lifestyle and AssuriTea supplementation work together to provide health benefits.”

Fritz says the next big evolution of the men’s health and prostate health supplement market will involve a continuing emphasis on safety. She also notes that botanical ingredients are growing in popularity. “Men’s health has been a fairly stable space the last few years, but there’s a larger demand for natural products. The entire [nutritional supplement] market is moving in that direction, so I expect men’s health to move in that direction as well.”

1. Katz A et al. “A green and black tea extract benefits urological health in men with lower urinary tract symptoms.” Therapeutic Advances in Urology, vol. 6, no. 3 (June 2014): 89-96
2. Herrlinger K et al. “A randomized double blind study of a green and black tea agent, AssuriTEA, in healthy male subjects.” Functional Foods in Health and Disease, vol. 5 no. 10 (October 2015): 350-364

Managing Pelvic Pain with Flower Pollen Extract

Recent research by urologists in Italy demonstrated the effectiveness of pollen extract as a supplement for men with chronic pelvic pain due to prostatitis, or inflammation of the prostate gland. Italian urological and sexual health supplement company IDIPharma recently published a randomized controlled clinical trial examining the effect of Deprox 500, a branded and patented supplement formulated with Graminex LLC’s (Saginaw, MI) branded and patented Graminex flower pollen extract, on prostatitis-associated chronic pelvic pain in 87 males with a mean age of 33.

Participants were randomized to take either two 500-mg tablets of Deprox per day or, in the case of the control group, 600 mg of ibuprofen (three 200-mg tablets) per day for four weeks.3 After one month, both groups saw improvements in scores on the National Institutes of Health Chronic Prostatitis Symptom Index. But the Deprox group saw an approximately 50% reduction in its score, compared to just an approximately 25% reduction for the ibuprofen group.

Colleen May, public relations representative for Graminex, says this study shows that Graminex’s flower pollen extract is effective at reducing prostatitis-associated pain. Says May: “IDIPharma found that our ingredient decreased the concentration of cytokines, specifically interleukins, in men with prostatitis.”

May says that pollen extract is gaining popularity as a prostate health supplement thanks to its natural origins and the fact that it represents a complex of compounds found in the raw ingredient, as opposed to, for instance, a pharmaceutical ingredient based on a single isolated compound. May says that she also expects food-based men’s health supplements to continue growing.

“We’re noticing that a lot of formulators want to put our ingredients into foods,” she says. “We’ve developed our own protein shakes that have pollen in them. A lot of the people taking our product are older active men with prostate issues, so the protein shake is a good way to deliver all the protein and amino acids needed to recover from a workout while also providing prostate health benefits.”

She notes that product identification is becoming increasingly important as the market for men’s health products grows. The next major innovations in the men’s health niche, May says, will involve further improvements in testing and verifying natural ingredients. “There’s a push in the industry for better identity testing,” she says. “There are a lot of products coming from overseas that claim to be from the United States. We’ve developed a lot of methods in house that we can send to our customers to ensure a product is what people say it is.”

3. Cai T et al. “Pollen extract in association with vitamins provides early pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome.” Experimental and Therapeutic Medicine, vol. 8, no. 4 (October 2014): 1032-1038

Easing Overactive Bladder with Botanicals

New data is emerging to demonstrate the usefulness of botanicals for addressing urinary issues in men. Tracey Seipel, ND, founder of Australian supplements marketer Seipel Group, says that her company recently published a clinical trial on its branded bladder-control supplement Urox, a patented combination of botanicals like Crataeva nurvala stem bark, Equisetum arvense stem, and Lindera aggregata root.

The randomized, double-blind, placebo-controlled trial followed 150 participants (average age 55) over the course of eight weeks. Participants took either 420 mg of Urox or a corresponding placebo once per day. The trial measured urinary frequency by self-report at weeks zero, two, four, and eight. By the end of the trial, the active supplement group reported a 30% reduction in daytime urinary frequency and a 54% reduction in nocturia. The placebo group saw lower reductions of 5% and 7%, respectively. The active supplement group also saw statistically significant reductions in both urgency and total incontinence relative to the placebo group.4

Seipel says that the ingredients in Urox may also assist with symptoms of prostate enlargement, but notes that the bladder-related symptoms typically ease before the prostate symptoms do. Seipel, who was one of the study authors, says that the subjects’ improvements occurred in stages. The urinary urgency symptoms saw statistically significant reductions by week two, she says, but the incontinence symptoms took four weeks to improve.

Seipel Group’s branded and patented Prorox supplement, designed to support overall prostate health, combines the Urox formula with 5-alpha-reductase, lycopene, and saw palmetto (Serenoa repens). Seipel says that botanicals will play an important role in prostate health supplements in the future, in conjunction with lifestyle factors.

“Beta-sitosterol is gaining in popularity right now,” she adds. “More research is needed, which is difficult with natural products because funds are limited. But over time, I see the men’s health supplement market becoming more comprehensive. Prorox looks at prostate enlargement, but also androgens, nutrition, and other factors. We need to move the public toward a more comprehensive understanding of health issues. Exercise helps to raise testosterone in men, which wards off certain health problems.”

4. Schoendorfer N et al. “Urox containing concentrated extracts of Crataeva nurvala stem bark, Equisetum arvense stem and Lindera aggregate root, in the treatment of symptoms of overactive bladder and urinary incontinence: A phase 2, randomised, double-blind placebo controlled trial.” BMC Complementary and Alternative Medicine, vol. 18, no. 1 (January 2

Probiotics Plus Cranberry Now Entering the Prostate Health Space

For many years, “prostate supplements” typically meant “herbal supplements.” But now, other kinds of ingredients are gaining notoriety in combination with other longstanding prostate health ingredients. Dan Souza, health and nutrition category manager for Naturex (Avignon, France), says that probiotics are now entering the men’s health category and being used in interesting combinations with existing prostate-health ingredients. For instance, Souza says, Naturex recently launched a version of its patented Flowens full-spectrum cranberry powder “that is optimized for use in combination with probiotics.”

“The low-water-activity formulation results in better shelf stability for the probiotics, and when consumed, the microbiome-accessible phytochemicals in combination with targeted probiotics may deliver synergistic benefits,” he says. He adds that ingredients like these also avoid the supply chain challenges facing some more traditional prostate health ingredients like saw palmetto. He notes that maintaining an adequate supply of saw palmetto continues to be an issue for the prostate health industry, and that saw palmetto faces both cost challenges and a growing risk of adulteration as supply-management struggles continue. This is why, he says, the industry is now sourcing different botanicals, like cranberry.

Naturex’s Flowens, made from cranberry fruit powder, has been shown in clinical trials to reduce LUTS symptoms in men, making cranberries a good candidate for men’s health and prostate health formulations. One randomized, double-blind, placebo-controlled clinical trial followed 124 men between the ages of 45 and 70 for six months. All participants were assessed using the International Prostate Symptom Score (IPSS) at zero, three, and six months. At the outset of the study, all participants scored between 8 and 19 on the IPSS, indicating that they all had moderate prostate symptoms.

During the study, participants took a once-daily dose of Flowens at either a concentration of 250 mg or 500 mg, or a placebo. After six months, all groups saw reductions in their IPSS rating, but the 250-mg and 500-mg Flowens groups saw reductions in their IPSS ratings of 3.1 and 4.1 points, respectively, while the placebo group saw a reduction of only 1.5 points.5

“In their report, the study authors noted that this level of reduction is considered to be clinically relevant under guidelines produced by the American Urological Association,” Souza notes. Flowens has also been awarded six health claims from Health Canada, he adds.

5. Vidlar A et al. “Cranberry fruit powder (FlowensTM) improves lower urinary tract symptoms in men: A double-blind, randomized, placebo-controlled study.” World Journal of Urology, vol. 34, no. 3 (March 2016): 419-424

Saw Palmetto Extract as Bioactive as Drug?

Research on saw palmetto has historically been mixed. While saw palmetto’s efficacy has been called into question by reviews and studies published in The Journal of the American Medical Association6, among other journals, a recent study was much more positively in favor of saw palmetto. This study demonstrated that saw palmetto was as effective as the prescription drug finasteride at relieving the symptoms of enlarged prostate.

The in vitro study examined the efficacy of both Euromed’s (Presto, PA) branded saw palmetto extract supplement Prosterol and of generic drug finasteride at inhibiting 5-alpha-reductase. Finasteride’s therapeutic effects for enlarged prostate are partly due to the drug’s ability to inhibit 5-alpha-reductase. The study found that a 10 microgram per milliliter dose of the saw palmetto extract resulted in a 91% mean inhibition of 5-alpha-reductase expression. A similar 8-nanometer dose of finasteride resulted in only an 82% mean inhibition, the researchers said.7

The study also found that Euromed’s saw palmetto extract acted through the same mechanisms as finasteride and was as effective as other industry-leading saw palmetto extracts at inhibiting 5-alpha-reductase, but without involving the harsh solvent hexane.

In a press release, Euromed said that its saw palmetto ingredient also offers several benefits due to its roots as a supplement ingredient. “No doctor’s prescription is necessary to obtain a proven bioactive prostate health dietary supplement; it spares the expense of the medical practitioner’s fees; it spares the high costs of prescription drugs; and, most importantly for health, it eliminates exposure to drug-related side effects.”

Euromed’s Director of U.S. Sales, Guy Woodman, says that Euromed recently completed construction of a new laboratory facility in Barcelona. New analytical equipment will improve quality-control measures related to Euromed’s saw palmetto extract, an important step that Woodman says is necessary on the heels of 2016’s saw palmetto shortage.

“A global shortage of saw palmetto oil extract opened the door for adulterated products from mainland China to enter the market,” Woodman says. “These adulterated products have the incorrect fatty acid profile and are missing the expected sterols and fatty alcohols. Euromed has been surveying the market and notifying trade organizations and industry stakeholders of this practice.”

6. MJ Barry et al. “Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms.” The Journal of the American Medical Association, vol. 306, no. 12 (September 28, 2011): 1344-1351
7. Pais P et al. “Determination of the potency of a novel saw palmetto supercritical CO2 extract (SPSE) for 5α-reductase isoform II inhibition using a cell-free in vitro test system.” Research and Reports in Urology. Published online April 21, 2016.

Botanicals for Prostate and General Health Support

Megan Luu, marketing manager for Gencor (Irvine, CA), says that Gencor is currently in the process of branding and trademarking a new men’s health ingredient derived from a plant native to Brazil. She says that Gencor expects this new supplement to receive GRAS status by the middle of 2018. Says Luu: “We’ve developed a new ingredient, an extract from the leaves of Ageratum conyzoides, that has shown 5-alpha-reductase inhibition activity in in vitro studies. This ingredient has also shown good efficacy for prostate health in a human clinical study.”

That human study—a double-blind, randomized, placebo-controlled clinical trial—followed 106 men between the ages of 41 and 76 with medically diagnosed benign prostatic hyperplasia for 12 weeks. Ninety-eight participants completed the study. Participants were assessed on the IPSS scale and were given 250 mg of Ageratum conyzoides or a placebo once per day. Secondary outcomes measured included testosterone and PSA levels as well as participant scores on the Aging Males’ Symptom Score and the Derogatis Interview for Sexual Functioning self-report. The trial showed that Ageratum conyzoides caused a statistically significant reduction in total IPSS score as well as a statistically significant reduction in day- and nighttime urinary frequency.8

Luu adds that, currently, Gencor’s focus is on diversifying delivery systems for men’s health products. “This space has been lacking in innovation, specifically around delivery systems, and has remained stale,” she says. “Most applications are restricted to softgels. We’ve broadened the delivery system space by bringing in an ingredient that can be used in other delivery forms like tablets, capsules, powders, and sachets.”

8. Detering M et al. “Ageratum conyzoides L. inhibits 5-alpha-reductase gene expression in human prostate cells and reduces symptoms of benign prostatic hypertrophy in otherwise healthy men in a double blind randomized placebo controlled clinical study.” BioFactors, vol. 43, no. 6 (November-December 2017): 789-800

Beyond the Prostate: New Opportunities in the Wider Men’s Health Market

Experts say the men’s health supplement market in general, and the prostate health supplement market in particular, aren’t just in the midst of diversifying product lines; the market is also developing a more comprehensive and holistic approach to and understanding of men’s health problems.

“I see the men’s health market becoming more comprehensive as time goes on,” Seipel says. “There are a few targeted ingredients that tend to dominate the market, and I’d like to see more innovation give way to a more multifaceted approach to men’s health.” Researching how lifestyle factors may affect prostate health is increasingly important, she adds.

At least one large-scale clinical trial is currently examining the connection between lifestyle factors and prostate health. The trial, dubbed the Men’s Eating and Living Study, is following 464 American men between the ages of 50 and 80 who have early-stage prostate cancer. The phase 3 randomized clinical trial, sponsored by the Alliance for Clinical Trials in Oncology in collaboration with the National Cancer Institute, ended last month. Preliminary results are expected soon.9

Prostate health is one of the most established realms of men’s health for supplement manufacturers to target, but new opportunities for manufacturers of men’s health supplements will likely occur both inside and outside the prostate arena. Gencor’s Luu says that the men’s health niche hasn’t seen much innovation in the last 10 years, and while this makes the niche a fairly reliable space for brands, it also means the industry is overdue for a shake-up.

Says Luu, “The men’s health supplement market has excellent growth potential, not just in prostate health, but also in healthy aging, active lifestyle, and andropause.”

Graminex’s May adds this: “The market looks different depending on whether you’re targeting older men or younger men. With older men, you’re talking prostate health ingredients. But with younger men, the products are more oriented around sports health—protein products, amino acids, etc.”

As the men’s health market continues to diversify, new opportunities will call for new formulations and products to meet evolving consumer demands. Manufacturers and brands can capitalize on growing awareness of men’s health issues with innovative formulations, strong research, and targeted marketing campaigns that reach household decision makers.

Also read: Drug-Supplement Interactions: Consumer Safety Remains a Priority

Prostate health supplements are a popular remedy for men who are facing age-related prostate difficulties. But the jury is still out on whether it is safe for men who are taking certain prescription medications to also take prostate supplements.

According to Harvard Medical School’s health publishing division, herbal remedies like saw palmetto may interact with drugs like naproxen or anticoagulants to increase the risk of bleeding in men with benign prostatic hyperplasia.10 However, many of the concerns around saw palmetto and its interactions with prescription drugs stem from isolated case reports and experimental studies of unknown clinical relevance.11 Further research is needed to clarify the mechanisms of interaction, if they exist, and to determine whether or not saw palmetto causes interactions with antiplatelets, anticoagulants, or NSAIDs.

ORIGINAL ARTICLE: http://www.nutritionaloutlook.com/herbs-botanicals/prostate-health-ingredient-research-tea-cranberry

Source: Nutritional Outlook

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