- Broader Study Will Build Upon the Successful Results of the First Trial Which Demonstrated NIAGEN® is a Safe, Effective NAD+ Precursor in Humans -
IRVINE, Calif., March 10, 2016 (GLOBE NEWSWIRE) -- ChromaDex Corp. (OTCQX:CDXC), an innovator of proprietary health, wellness and nutritional ingredients, that creates science-based solutions to dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products, announced today the initiation of the second human clinical trial for its patented ingredient, NIAGEN® (Nicotinamide Riboside - NR).
The second human clinical trial will build upon the results of the Company’s first human clinical trial announced in February 2015 which demonstrated that a single oral dose of NIAGEN® is a safe, effective nicotinamide adenine dinucleotide (NAD+) precursor in humans. The results of that study constituted a significant milestone as it showed for the first time an increase in NAD+ in humans has been demonstrated through NR supplementation.
The second human clinical trial will be a randomized, double-blind, placebo controlled parallel study in 140 healthy adults ranging in age from 40-60, which will examine the benefits of NIAGEN® if taken daily for eight consecutive weeks. The outcome will provide key information on the effective dose range of NIAGEN® to increase the mitochondrial co-enzyme NAD+ and NAD+ metabolite concentrations in the body.
Additional endpoints to be investigated include: C-reactive protein, total cholesterol, LDL, HDL and triglycerides and amino acid panels, NAD+ levels in muscle, mitochondrial biomarkers, and the effects of NR on Resting Metabolic Rate.
Frank Jaksch Jr., founder and CEO of ChromaDex, commented “Given the success of the first human trial of NIAGEN®, we have been eager to generate additional human data demonstrating NR is an effective precursor to NAD+.”
ChromaDex’s NIAGEN® is the only commercially available form of NR and is supported by five patents issued and several pending, with patents rights acquired from Cornell University, Dartmouth College and Washington University. In addition to human clinical studies, ChromaDex is actively collaborating with numerous leading universities and research institutes studying the health benefits of NIAGEN®.
Maintenance of sufficient levels of NAD+ is key to cellular energy metabolism and mitochondrial function. If NAD+ levels go down or if NAD+ is redirected (as in cancer cells), mitochondrial function erodes, creating numerous adverse effects. For example, results of a mouse study conducted by the National Institutes of Health (NIH) in collaboration with ChromaDex published in November 2014 indicated that NR was effective at restoring NAD+ levels in mitochondria and rescuing phenotypes associated with a devastating accelerated aging disease known as Cockayne Syndrome (CS). The researchers concluded that NR showed promise as a potential therapy for the disease, as well as for other age-related neurodegenerative conditions.
Published research has shown that NR is perhaps the most effective precursor to boost the co-enzyme NAD+ in the cell. NAD+ is arguably the most important cellular co-factor for improvement of mitochondrial performance and energy. In recent years, NAD+ has been shown to be essential in supporting healthy cellular metabolism including the efficient conversion of blood glucose into energy.
As organisms age NAD+ levels drop, which leads to a decrease in mitochondrial health; this in turn leads to age-related health issues. Low NAD+ levels limit activity of a group of enzymes called sirtuins, which are believed to play a key role in longevity. NAD+ levels can be depleted by lifestyle choices such as overeating and lack of exercise. By boosting NAD+, NR can increase mitochondrial health and induce creation of new mitochondria.
About Nicotinamide Riboside (NR):
Sometimes referred to as the "hidden vitamin," NR is found naturally in trace amounts in milk and other foods. Researchers around the world are studying the effect of NR on mitochondria, the powerhouses of the cell, where macronutrients are converted to energy the cell can use. Mitochondria also play an important part in the aging process. Scientists hope that the stimulation of mitochondrial function with NR may result in increased longevity as well as other health improvements. Researchers worldwide are continuing to make seminal discoveries characterizing the unique properties of NR in a wide range of health benefits, including increased mitochondrial health, increased muscle endurance, neuroprotection, sirtuin activation, protection against weight gain on high-fat diet, protection against oxidative stress and improvement of blood glucose and insulin sensitivity.
A study by researchers from Harvard Medical School conducted in conjunction with the National Institute on Aging and published in December 2013 in Cell demonstrated that mitochondrial dysfunction (a hallmark of aging) in aging mice is due to a disruption in Sirtuin1-dependent nuclear-mitochondrial communication. The study further showed that a reduction in NAD+ levels is responsible for this disruption. Excitingly, the study demonstrated that this mitochondrial dysfunction is readily reversible by the administration of a NAD+ precursor. The study reported that "1 week of treatment with a compound that boosts NAD+ levels is sufficient to restore the mitochondrial homeostasis and key biochemical markers of muscle health in a 22-month-old mouse to levels similar to a 6-month-old mouse," indicating that some aspects of aging may be theoretically reversible.
Separately, findings from a 2012 study conducted by researchers at Weill Cornell Medical College and the Ecole Polytechnique Federale de Lausanne, Switzerland showed that mice on a high-fat diet that were fed NR gained less weight than mice eating the same high-fat diet without NR. Moreover, unlike the mice that were not fed NR, none of the NR-treated mice had indications that they were developing diabetes and their energy and cholesterol levels improved, all without side effects. The Swiss researchers were quoted as saying the effects of NR on metabolism were "nothing short of astonishing."
ChromaDex leverages its complementary business units to discover, acquire, develop and commercialize patented and proprietary ingredient technologies that address the dietary supplement, food, beverage, skin care and pharmaceutical markets. In addition to our ingredient technologies unit, we also have business units focused on natural product fine chemicals (known as "phytochemicals"), chemistry and analytical testing services, and product regulatory and safety consulting (known as Spherix Consulting). As a result of our relationships with leading universities and research institutions, we are able to discover and license early stage, IP-backed ingredient technologies. We then utilize our in-house chemistry, regulatory and safety consulting business units to develop commercially viable ingredients. Our ingredient portfolio is backed with clinical and scientific research, as well as extensive IP protection. Our portfolio of patented ingredient technologies includes NIAGEN® nicotinamide riboside; pTeroPure® pterostilbene; PURENERGY®, a caffeine-pTeroPure® co-crystal; ProC3G®, a natural black rice containing cyanidin-3-glucoside; IMMULINA™, a spirulina extract; and Purple Corn derived from a proprietary non-GMO purple corn hybrid which contains an extraordinarily high level of anthocyanins. To learn more about ChromaDex, please visit www.ChromaDex.com.
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects", "anticipates", "intends", "estimates", "plans", "potential", "possible", "probable", "believes", "seeks", "may", "will", "should", "could" or the negative of such terms or other similar expressions. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in ChromaDex's business. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended January 3, 2015, ChromaDex's Quarter Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.
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