Ninety days of supplementation with Natreon’s PrimaVie-branded purified Shilajit were associated with a 20% increase in total testosterone and a 19% increase in free testosterone levels, according to findings published in Andrologia.
Shilajit, a herbo-mineral exudate, is derived from mountainous regions across Asia. It is also called mumie, moomiyo, or mummiyo. Natreon obtains its Shilajit from the Himalayas, said the company.
Aparna Kalidindi, PharmD, Sales & Marketing Manager for Natreon, told NutraIngredients-USA: “This is an important study because it looked at healthy subjects whereas the previous testosterone study on PrimaVie was conducted in subjects with oligospermia.
“Manufacturers of male sexual health products now have a new ingredient with studies to back up safety and efficacy. The main reason behind men’s sexual health issues is testosterone. PrimaVie has shown to directly address this issue by increasing both free and total testosterone levels.”
Safety and efficacy
Sidney Stohs, PhD, Dean Emeritus at the Creighton University Medical Center in Nebraska, reviewed the scientific literature around Shilajit in 2014 in Phytotherapy Research (Vol. 28, pp. 475-9), and noted that: “The physiological and pharmacological effects of shilajit are attributed to the [dibenzo-alpha-pyrones] DBPs, DBP chromoproteins (DBPs conjugated to proteins), fulvic acid, and various polymeric forms of fulvic acid.
“In spite of the use of shilajit (moomiyo, mumie) for many years, relatively few peer-reviewed, human, controlled, and published research studies have been conducted,” noted Dr Stohs. “Studies in both animals and humans indicate that the use of shilajit is safe and generally free of adverse effects. Published human and animal studies have indicated that shilajit increases spermatogenesis in infertile males. A human study demonstrated that shilajit when given at high (2000 mg/day) doses has beneficial effects with respect to blood lipids.
“[I]t should [also] be noted that products exist on the market that do not conform to the chemical composition of ‘standard’ shilajit and may be either adulterated or counterfeit,” wrote Dr Stohs. “As a consequence, caution must be taken with respect to shilajit acquisition, and only processed and standardized products should be used. A need exists for further studies in animals and humans with processed and standardized shilajit preparations.”
Natreon’s PrimaVie-branded purified Shilajit is standardized to contain, “not less than 60% w/w of total bioactives, which include not less than 50% w/w of fulvic acids, not less than 0.3% w/w of DBPs and not less than 10% w/w of dibenzo-alpha-pyrone chromoproteins (DCPs),” wrote the researchers, led by Tuhin Biswas from the J. B. Roy State Ayurvedic Medical College and Hospital.
The researchers recruited 75 healthy men aged between 45 and 55 to participate in their randomized, double blind, placebo-controlled study. The men were randomly assigned to receive either placebo or 500 mg per day of PrimaVie for 90 days.
Results showed that supplementation with PrimaVie lead to a 20% increase in total testosterone levels and a 19% increase in free testosterone levels after 90 days.
“The significant betterment of DHEAs [the main precursor of testosterone] with the treatment of purified Shilajit signifies its role on testosterone synthesis,” they wrote. “Other two gonadotropic hormones, viz. [luteinising hormone (LH) and follicle-stimulating hormone (FSH)], were studied in this present work, to rationalize the hypothalamo-pituitary–testicular axis, where both of these hormones were in maintained levels indicating their initial role of triggering of testosterone production. This was followed by downregulation of LH and FSH on one hand and maintenance of the hypothalamo-pituitary–testicular axis by means of elevated level of testosterone on 30, 60 and 90 days on the other hand.
“All these modus operandi of purified Shilajit on synthesis and stimulation of testosterone are found to be better than placebo-treated group in healthy male volunteers in age group of 45–55 years, who may undergo andropause in normal course.”
Sexual health category
Dr Kalidindi told us that the male sexual health supplement industry is growing as the baby boomer generation is now reaching retirement age. “More older adult males are turning to nutritional supplements to support and maintain their lifestyles. According to the Nutrition Business Journal, the natural supplement market for promoting sexual health products is poised to reach an estimated worth of $905 million by 2020.”
While the sexual health market has received a lot of attention from the regulators, it is not the only category to have suffered from criticism, said Dr Kalidindi.
“Solid science is critical in every category of the dietary supplement industry especially after what happened with the NYAG. Natreon has achieved a reputation within the industry as a company that backs up every ingredient with multiple efficacy and safety studies. Our ultimate goal is to gain the trust of our consumers so they continue to take our products and this would not happen with false science and adulterated products.”
Published online ahead of print, doi: 10.1111/and.12482
“Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers”
Authors: S. Pandit, S. Biswas, U. Jana, R. K. De, S. C. Mukhopadhyay and T. K. Biswas