First human clinical study of ChromaDex's NIAGEN nicotinamide riboside meets primary endpoint

ChromaDex Corp. (OTCQX: CDXC) announced today that the initial results of the first human clinical study for the company's NIAGEN® nicotinamide riboside (NR) has met its primary endpoint. The results demonstrated that a single dose of NR resulted in statistically significant increases in the co-enzyme nicotinamide adenine dinucleotide (NAD+) in healthy human volunteers. The study shows for the first time a similar conversion of NR into NAD+ as has been shown in prior animal studies.

Maintenance of sufficient levels of NAD+ is key to cellular energy metabolism and mitochondrial function. If NAD+ levels go down or are 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.

In the first human clinical study of NIAGEN®, NAD+ metabolomic analyses were completed in blood for various time points over a 24-hour period. For the first time, the study also established an effective dose range for NR in humans.

A preliminary analysis of the results did not reveal any safety issues with NR, which is consistent with previous safety results demonstrated in numerous cell and animal studies.

The full results of the study will be submitted for peer review in the scientific literature.

The NAD+ metabolomics analyses were performed in the laboratory of Dr. Charles Brenner, the Roy J. Carver Chair of Biochemistry and Professor of Internal Medicine at the University of Iowa. In 2004, Brenner, who was then a faculty member at Dartmouth College, discovered NR to be a vital precursor of NAD+, which is made available by nicotinamide riboside kinases (Nrks) that are conserved between yeast and humans. In 2007, Dr. Brenner's lab discovered a second pathway by which NR is converted to NAD+ and showed that NR can extend the lifespan of yeast cells by virtue of elevating NAD+ levels and increasing the activity of the NAD+-dependent Sir2 enzyme.

Dr. Brenner commented, "The results of this study constitute a significant milestone in the translation of NR technologies as it is the first time an increase in NAD+ in humans has been demonstrated through NR supplementation. As noted in numerous scientific studies, the potential health and therapeutic benefits of NR as a precursor to NAD+ are significant. The results of this clinical study should encourage more studies and research regarding the possible health benefits of NR in humans."

Nobel Laureate Dr. Roger Kornberg, who chairs ChromaDex's Scientific Advisory Board, commented, "Demonstrating that NR is an effective precursor to increase NAD+ in humans has significant positive implications and may be a cornerstone to developing solutions to delay or reverse the effects of aging, obesity and disease."

Frank Jaksch Jr., founder and CEO of ChromaDex, commented, "We believe the confirmation that a single dose of NR increases NAD+ in humans is a landmark result and a significant bridge between the numerous animal studies previously conducted that have demonstrated not only an increase in NAD+, but also a broad range of therapeutic benefits."

Jaksch continued, "Dysfunctional cellular energy metabolism in mitochondria is increasingly implicated in diseases of aging, autoimmune diseases, muscle wasting, neuropathies and other conditions, and this study opens the door to the development of both consumer products and pharmaceuticals addressing these conditions."

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 Dartmouth College, Cornell University and Washington University.

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 also been shown to participate as an extracellular signaling molecule in cell-to-cell communication. NAD+ is 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 the activity of a group of enzymes called sirtuins, which are believed to play key roles in longevity. NAD+ levels can be depleted by many of the stresses of life. By boosting NAD+, NR can increase mitochondrial health and induce creation of new mitochondria.

Source:

ChromaDex Corp.

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Comments

  1. Lang Trostler Lang Trostler United States says:

    Please share the effective dosing range information! I have been basing my dosage on the mouse study dosage converted using the surface area difference from mice to humans. This is a very much larger and very much more expensive dose than is recommended on the bottle. I have had wonderful results.

  2. Steven J. Hendriks Steven J. Hendriks United States says:

    The article makes mention that"...For the first time, the study also established an effective dose range for NR in humans." - So what is it?

  3. S Talbutt S Talbutt United Kingdom says:

    Is there any reason why  Niagen should not be used if Levothyroxine is being taken for hypothyroidism?

    • James Berry James Berry United States says:

      I too am on Levothyroxine 112mg/day and started taking Basis a compound similar to Niagen and within two weeks came down with Peripheral Neuropathy and joint and muscle pain.  Did you ever get an answer to your question about Lovothroxine and Niagen use? Any input would be greatly appreciated.  James Berry

      • Sara Stein MD Sara Stein MD United States says:

        If you have a methylation defect, NAD can precipitate neuropathy, pain, fatigue. I'm guessing if you took methylated B vitamins with the NAD it might prevent those side effects, but everybody's different.

        • Gerard Fowke Gerard Fowke United States says:

          I experienced major lower back and neck pain while taking NIAGEN (nicotinamide riboside) -- shouldn't this be listed as a side effect. It also, made my hurting joints extremely noisy. I relate my symptoms similar to eosinophilia-myalgia syndrome (EMS).

          Doses more than 250 mg of nicotinamide (B3) now cause the same pain too.

          I have taken for years MSM, TMG and methylated B vitamins.

          I have not experienced the same when taking NADH or coenzymated B3 (nicotinamide adenine dinucleotide).

          Seems to me the pain can not be from the NAD.

  4. Gerard Fowke Gerard Fowke United States says:

    I took NIAGEN (nicotinamide riboside) for a couple of weeks and experienced extreme pain in my neck and lower back. My hurting joints were also very noisy.

    I have taken and was taking MSM, TMG and methylated B12 for years. I can take NADH and Coenzymated B3 (nicotinamide adenine dinucleotide) and not experience the same pain.
    -- I DON’T UNDERSTAND HOW NAD COULD HAVE CAUSED MY PAIN.-- (As mention by Sara Stein MD)

    I equate my pain to that of getting a bad batch of L-Trytophan and getting EMS (eosinophilia-myalgia syndrome).

    This should be listed as a side effect of NIAGEN (nicotinamide riboside).

  5. Gerard Fowke Gerard Fowke United States says:

    Instead of taking NIAGEN (nicotinamide riboside) which has to be converted to NAD; why not take a substance that is a form of NAD [either NADH or Coenzymated B3 (nicotinamide adenine dinucleotide)].  I don’t know the conversion rate of NIAGEN to NAD, but I immediately feel mental alertness when taking either of these forms of NAD at 1/20th the dose of NIAGEN. Whereas, I had to stop taking NIAGEN before I felt the same effect (see my post of October 10, 2016 at 5:27 PM).  Why isn’t there studies showing results of how much NAD increases in the cells of the body when taking the direct forms of NAD? The only reason I can think of is ChromaDex doesn’t have a patent on the forms of NAD and would not want to do a study on something that would be in direct competition with their product.

  6. Liz kazman Liz kazman United States says:

    When I first started using this product I began having pains in my ankles and feet, made walking a distance a problem, over time this got better but was replaced by back pain, ranging from middle back to lower back, finally I had to stop.  
    After a while I tried it again, same issues leg pain and back pain which does not get better over time.  I have dropped this product and returned the unused portion for refund.  This is not for me.  I have read on Longecity of other with similar pain issue in legs and back, but no one know why it happens.  Too bad.

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
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