|View printer-friendly version|
|ChromaDex Initiates Second Human Clinical Study on NIAGEN® -The World’s First and Only Commercially Available Form of Nicotinamide Riboside (NR)|
- Broader Study Will Build Upon the Successful Results of the First Trial Which Demonstrated NIAGEN® is a Safe, Effective NAD+ Precursor in Humans -
The second human clinical trial will build upon the results of the Company’s first human clinical trial announced in
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.
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
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
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."
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
Statements in this press release have not been evaluated by the
ChromaDex Company Contact: