|Study results will help to define the effective dose range of nicotinamide riboside (NR) in humans when taken daily, over eight weeks.
IRVINE, Calif., July 20, 2016 (GLOBE NEWSWIRE) -- ChromaDex Corp. (NASDAQ:CDXC), an innovator of proprietary health, wellness and nutritional ingredients that creates science-based solutions for dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products, announced today that the study of NIAGEN® - nicotinamide riboside is well underway having achieved 50% enrollment of its 140 total participants.
This trial is examining the effective dose range of NIAGEN® to increase NAD+ and NAD+ metabolite concentrations in the body with consistent use over time. The study design is an 8-week, randomized, double-blind, placebo controlled parallel trial in 140 healthy adults ranging in age from 40-60. Study participants in the active group receive between 100-1000mg per day. Additional endpoints 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.
Najla Guthrie, President and CEO of the contract research organization responsible for coordinating the trial, KGK Synergize Inc. commented, “We have been very pleased that enrollment has gone smoothly. If things continue along this path we would be on track to have results collected around December.”
In addition to this trial, there are eight other collaborative human studies actively underway which are sponsored by entities other than ChromaDex. There are also four additional human trials which are also estimated to begin sometime over the next 6 to 9 months. Frank Jaksch, Jr., CEO and co-founder of ChromaDex stated, “These are exciting times for the ChromaDex team and the scientific community at large. New research seems to be publishing on almost a weekly basis, further building the body of evidence around the effectiveness of NR and the importance of boosting NAD+. We look forward to sharing more about our study results in early 2017.”
This is the second human clinical study sponsored by ChromaDex. The first human clinical trial announced in February 2015 demonstrated that a single oral dose of NIAGEN® is a safe, effective NAD+ precursor in humans.
NAD+ is an essential metabolite which activates cellular metabolism and cellular energy production within the “powerhouses of the cell” - the mitochondria. The mitochondria’s key role within the cell is to convert nutrients such as fats, proteins and carbohydrates into energy which is necessary to power all bodily systems and functions. Decreased efficiency in the mitochondria is linked to a number of adverse health conditions such as metabolic syndrome.
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 the communication between the cell’s nucleus and its mitochondria. 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 the mitochondria were “rejuvenated,” and that some aspects of aging may be theoretically reversible.
About the NAD+ precursor (or booster), Nicotinamide Riboside (NR):
Sometimes referred to as “The forgotten B3," the benefits of NR remained unknown for years after its initial discovery and classification as a vitamin B3, due to the lack of advanced understanding of nucleotide science. It was not until 2004 that this hidden gem resurfaced after Dr. Charles Brenner, then professor at Dartmouth, identified the missing link as to how NR becomes NAD+. This discovery also suggested that NR also had the ability to boost NAD+ in a more energy efficient way than could be achieved with its B3 cousins, niacin or nicotinamide, leaving the body extra energy to focus on its critical needs and processes. NR’s unique energy sparring ability to produce NAD+ has excited the scientific community around the world. This excitement has led to 70 material transfer agreements to top research institutions all studying the effects of NR in separate therapeutic endpoints. The body of evidence continues to build as researchers make seminal discoveries characterizing the unique properties of NR in a wide range of health benefits, including increased mitochondrial health resulting in improved cellular energy production, increased muscle endurance, neuroprotection, improvements in longevity, protection against weight gain when consuming a high fat diet, protection against oxidative stress and improvement of blood glucose and insulin sensitivity. NIAGEN® is the world’s first and only, nature identical form of NR commercially available today.
Dr. Brenner now sits on the scientific advisory board at ChromaDex.
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 anthocyanins derived from a domestically-produced, water-extracted purple corn. 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, including statements related to the timing and results of the study of NIAGEN® - nicotinamide riboside for long term use. 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, including, without limitation, the timing and results of the study of NIAGEN® - nicotinamide riboside for long term use, 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 2, 2016, ChromaDex's Quarterly 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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