ChromaDex, Inc. Announces Commencement Of An Obesity-Related Clinical Study Of NIAGEN In Collaboration With The University of Copenhagen And Aarhus University
IRVINE, Calif., Feb. 22, 2016 (GLOBE NEWSWIRE) -- ChromaDex Corp. (OTCQX: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 the enrollment of the first patients for a collaborative human clinical study of NIAGEN® (nicotinamide riboside – NR) at the University of Copenhagen.
ChromaDex’s patented ingredient NIAGEN® is the first and only commercially available form of nicotinamide riboside (NR), a naturally occurring vitamin B3 metabolite found in milk.
The placebo controlled, double-blind, randomized study of 40 obese healthy men will assess the potential benefits of daily NIAGEN® supplementation over the course of 12 weeks. Endpoints that will be assessed include insulin sensitivity, body composition, and overall metabolism. ChromaDex will provide NIAGEN® for the study along with matched-placebo control pills.
This new study will build upon the first successful clinical trial conducted in 2015 which demonstrated that a single dose of NIAGEN® can elevate the co-enzyme NAD+ in the blood by as much as 2.7-fold and was safe. 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.
Frank Jaksch Jr., founder and CEO of ChromaDex, commented, “We are honored to collaborate with Dr. Treebak’s lab on this clinical trial. The Novo Nordisk Foundation Center for Basic Metabolic Research is one of the leading research institutions studying diabetes and obesity. The human study is designed to provide a better understand on how NR can help people optimize their physical and metabolic functions.”
Dr. Jonas Treebak, the principal investigator of the study commented, “The ability to maintain mitochondrial function in insulin sensitive tissues in the body appears to be tightly linked to development of insulin resistance, obesity, and Type 2 Diabetes. With support from ChromaDex, it is possible for us together with researchers from the Department of Clinical Medicine, Aarhus University, to engage in this important and exciting research area to answer fundamental questions regarding the role of NAD+ metabolism in these diseases; hopefully, for the health benefit of millions of people world-wide.”
ChromaDex, through more than 50 collaborations with researchers around the world, is at the forefront of research showing that the use of NR helps preserve or restore mitochondrial function and may be beneficial in treating and/or preventing disease.
About Nicotinamide Riboside (NR)
Sometimes referred to as the "hidden vitamin," NR is a form of Vitamin B3 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.
While scientists have known for decades that mitochondria produce energy for cells, it is only recently that mitochondrial function has been linked to general health, aging and numerous disease conditions. The key to mitochondrial function is the maintenance of sufficient levels of NAD+, which is used to generate energy efficiently and allows overall mitochondria function, such as signaling immune regulation and cell death to proceed properly. If NAD+ levels go down or if NAD+ is redirected (as in cancer cells), mitochondrial function erodes, creating numerous adverse effects. Scientists have begun to show in animal models that the stimulation of mitochondrial function with NR may result in increased longevity as well as other health improvements. At the same time, mitochondrial dysfunction has been increasingly linked to a broad range of disease conditions, including autoimmune diseases, macular degeneration, cancer, Alzheimer's and other central nervous system diseases, Duchenne muscular dystrophy and others.
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 supplemented with NR gained 60 percent less weight than mice eating the same high-fat diet without NR supplementation. 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."
About 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 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.
About The Novo Nordisk Foundation Center for Basic Metabolic Research:
The Novo Nordisk Foundation Center for Basic Metabolic Research is a center of excellence where a team of talented researchers and experienced laboratory technicians is bringing scientific discoveries from the laboratory to the society in an effort to tackle some of today’s biggest challenges – diabetes and obesity. The close interdisciplinary collaboration between more than 100 skilled scientists through 6 scientific sections is one of our unique strengths, enabling us to discover more effective strategies to prevent, control and, ultimately, cure metabolic diseases. By committing ourselves to innovative research, by being home to 2 state-of-the-art core facilities, by fostering knowledge and education, we are striving to create a unique environment within a great university and a prominent health care system.
About The University of Copenhagen:
With its more than 530 years, the University of Copenhagen (UCPH) is one of the oldest universities in Northern Europe. Being one of the largest institutions of education and research in Denmark, including over 40,000 students and more than 9,000 employees, the University of Copenhagen is also one of the largest institutions of research and education in the Nordic countries. In 2007, The University of Copenhagen merged with The Royal Veterinary and Agricultural University and The Danish University of Pharmaceutical Sciences. After the merger, the University of Copenhagen contains one of the largest Health and Life Science Centres in Northern Europe.
About Aarhus University:
Aarhus University (AU) was founded in 1928. It has a long tradition of partnerships with some of the world's best research institutions and university networks. Among over 17,000 universities world-wide, Aarhus University is ranked in the top 100 by several influential rankings. Since the university was founded, it has provided the Danish as well as the international communities with more than 130,000 graduates. Today, the AU has more than 44,000 students and 11,000 employees.
Forward-Looking Statements:
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.
Statements in this press release have not been evaluated by the Food and Drug Administration. Products or ingredients are not intended to diagnose, treat, cure or prevent any disease.
ChromaDex Investor Contacts: The Del Mar Consulting Group, Inc. Robert B. Prag, President 858-794-9500 bprag@delmarconsulting.com ChromaDex Company Contact: Andrew Johnson, Director of Investor Relations 949-419-0288 andrewj@chromadex.com