Umasudhan (Uma) Pal., president, and CEO for Florida-based Valensa International, has announced that a comparison study of Valensa’s USPlus Serenoa repens lipidosterolic extract to the herbal medicine Permixon in the mechanistic enzyme activity associated with prostate health and hair loss was just published in the journal Uro.
In this new pre-clinical study, the researchers compared two standardised lipidosterolic extracts of Serenoa repens - a proprietary ultrahigh-pressure supercritical carbon dioxide extract of S. repens (UHP-sCESr), USPlus) and the well-established hexanic extract of S. repens (HESr, Permixon) - for both 5αR inhibition activity and lipid profiles.
The data demonstrated that both UHP-sCESr and HESr had nearly identical inhibition curves and comparable IC50 (potency measurement) values for both 5αR-1 and 5αR-2, which convert testosterone to dihydrotestosterone. Both saw palmetto extracts also had comparable lipid profiles based on total fatty acid levels, weight/weight comparisons of individual fatty acids, and individual fatty acid ratios to lauric acid.
HESr (Permixon) meets the standard set by the European Medicines Agency (EMA) for a well-established use medicinal product. And, according to Margaret H. Dohnalek, PhD, Chief Science Officer and Senior Vice President, Research and Innovation for Valensa International: “USPlus meets the standard set by the United States Pharmacopeia (USP) monograph for authenticity and purity of a supercritical carbon dioxide (SCCO2) extract of saw palmetto.”
The study authors concluded that UHP-sCESr (USPlus) offers a comparable, standardised lipidosterolic saw palmetto extract for men with lower urinary tract symptoms (LUTS) due to enlarged prostate in regions such as North America where the proprietary HESr (Permixon) is not available.
Another finding in this study is the equally strong inhibition of 5 alpha reductase type 1, which is predominantly found in skin and hair. Through inhibiting this enzyme, production of dihydrotestosterone is likewise reduced, which can slow down androgenic-mediated hair loss associated with this conversion of testosterone into DHT.
The products in the market are inconsistent and many do not provide an extract with the fatty acid profile and dose for clinical effectiveness
According to the NIH’s National Institute of Diabetes and Digestive and Kidney (NIDDK), approximately 14 million men in the U.S. have lower urinary tract symptoms associated with an enlarged prostate (benign prostatic hyperplasia or BPH), and 50% of men between 50 and 60 years of age are affected by BPH, risk of which increases with age.
“Saw palmetto (Serenoa repens) has been a staple botanical for men’s urological health. However, the products in the market are inconsistent and many do not provide an extract with the fatty acid profile and dose for clinical effectiveness,” said Dohnalek. “Valensa’s USPlus, saw palmetto, a patented pure lipidosterolic extract, delivers the mechanism of action and represents the lipid profile shown by the global body of literature to provide specific support to the prostate in men exhibiting lower urinary tract symptoms.”
Clinical studies indicate that standardised saw palmetto is effective in controlling urinary urgency and frequency observed in men beyond the age of 50 when taken only as a lipidosterolic extract of Saw Palmetto with minimum 80% total fatty acids that meets USP or EU monograph, at the efficacious dose of 320 mg daily. In vitro tests further confirm that its mechanism of action is based on its ability to inhibit 5-alpha reductase mediated transformation of testosterone to the more potent androgen dihydrotestosterone whose abundance has been linked to urinary flow issues in older men.
Inhibition of 5 alpha-reductase enzymes (5αR-1 and 5αR-2), which prevent the conversion of testosterone to its active metabolite, dihydrotestosterone, has been shown to impact further prostate enlargement. Clinical trials of standardised lipidosterolic extracts of Serenoa repens (LSESr), also known as standardised extracts of saw palmetto, have demonstrated improvement in LUTS and delayed progression of symptoms.
Valensa International is a leading innovator and next-generation supplier of pure, science-based, clinically effective nutraceutical ingredients proven to benefit health and wellness. For over 20 years, Valensa has partnered with nutraceutical, cosmeceutical, food, and pharmaceutical companies to bring condition-specific results to market for human and companion animal well-being. Valensa is a fully integrated manufacturer of USPlus lipidosterolic extract of Saw Palmetto that has applications in fulfilling unmet needs in men’s prostate and urinary health, and emerging hair wellness category for women and men.
USPlus lipidosterolic extract is the first and only U.S. Pharmacopeia verified ingredient from Saw Palmetto. The company’s commitment to safety, quality and the environment is represented by the United States Pharmacopeia (USP) Dietary Ingredient Verification Program, FDA cGMP compliance and sustainability practices. Valensa, headquartered close to Orlando, Fla., near a protected saw palmetto grove, supports ecological harvesting practices and manufacturing technologies that have been proven to be environmentally sound.
