Gencor’s new prostate health ingredient: ‘There hasn’t been much innovation in this category until now’

By Stephen Daniells contact

- Last updated on GMT

Ageratum conyzoides.  Image © Getty Images / eyepark
Ageratum conyzoides. Image © Getty Images / eyepark

Related tags: Prostate, Herbal dietary supplements, extracts, Men's Health

Gencor is aiming to shake up the prostate health category with its Ageratum conyzoides extract. The category, which has not been the focus of much innovation for years, is dominated by saw palmetto.

Ageratum conyzoides ​has traditionally been used in the Caribbean for prostate and urinary problems, but Gencor is now growing the plant in India. The company’s new ingredient is branded AgeProst.

“As men age, prostate health becomes top of mind, and this unique extract has been clinically tested and shown to reduce symptom severity according to study applicants in the International Prostate Symptom Score (IPSS),”​ said R.V. Venkatesh, Managing Director at Gencor. “We are thrilled to add yet another unique and clinically validated ingredient to our portfolio.”

The potential prostate benefits of the ingredient – which contains terpenoids, sterols, flavonoids, coumarins, and lignans – are linked to its activity as a 5-a-reductase inhibitor.

Speaking with NutraIngredients-USA at the recent SupplySide West in Las Vegas, Venkatesh said the company has been working on the ingredient for five years.

RCT data

The ingredient is already supported by data from a double-blind randomized placebo controlled clinical trial published in BioFactors​. Scientists from the Queensland University of Technology, The University of Sydney, ABICH S.r.l (Italy), and Medlab Clinical in Sydney recruited 109 men aged between 41-76 years with medically diagnosed benign prostatic hypertrophy (BPH) to participate in their study.

The 12-week study compared the effects of the A. conyzoides​ extract at a daily dose of 250 mg with placebo.

Results showed that for the primary outcome measures of the International Prostate Symptom Score (IPSS) and daily urinary frequency, men in the AgeProst group experienced significant reductions in IPSS, and significant reductions in day-time and night-time urinary frequency. The reductions in urinary frequency were observed after four weeks, and maintained for the rest of the study period, said the researchers.

The inhibition of 5-alpha-reductase enzyme activity was also supported by an additional in vitro​ test.

“[T]his A. conyzoides extract may be a promising safe and effective treatment for reducing symptoms of BPH, by mechanisms that may involve both androgen moderation and/or anti‐inflammatory and antispasmotic actions in healthy middle‐aged and older men,”​ concluded the researchers.

Regulatory status

Gencor has also carried out toxicological studies (Regulatory Toxicology and Pharmacology, Palmer et al. 2019, Vol. 103, pp. 140-149​) and the ingredient is self-affirmed GRAS (generally recognized as safe) in the US. A novel foods dossier will be submitted by the end of the quarter with EFSA in EU, said Venkatesh, and they company will also submit a health claims dossier to the Agency.

Quite a few product launches are in the pipeline for the US market, said Venkatesh.

Chase Shryoc, VP of Business Development at Gencor, ​added: “We expect AgeProst to be a strong contender in the men’s health marketplace due to its significant positive results shown from the clinical studies. With several in-vitro and in-vivo studies, AgeProst is a well-researched, self-affirmed GRAS status ingredient with an excellent safety profile.”​ 

Saw Palmetto – Supply pressure and adulteration

The prostate health category is dominated by extracts from the berries of saw palmetto (Serenoa repens​), with the effects also linked to improvements in symptoms related to BPH.

Dietary supplement products containing saw palmetto berries and/or their extracts are among the top-selling botanical dietary supplements in the United States — ranking 11th in the mainstream market (supermarkets, drug stores, grocery stores, etc.) and 14th in the natural foods channel with a combined $35 million in sales for both channels, according to the latest HerbalGram Herb Market Report​ for 2018.

However, poor harvests over the past several years, coupled with a possible impact from new permitting requirements by the Florida Department of Agriculture and Consumer Services, has led to demand outstripping supply. As a result, prices increased substantially in 2018, and adulteration has become more commonplace​.

Hair growth

In addition to the potential prostate benefits, there is also emerging evidence that the Ageratum conyzoides​ extract may help with hair growth. Gencor has already invested in open label studies, and recently launched a double-blind study for hair growth.

Source: BioFactors
2017, Volume 43, Issue 6, Pages 789-800. doi: 10.1002/biof.1389
“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”
Authors: M. Detering

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