Study supports long-term safety of ChromaDex’s Niagen ingredient
Data from a randomized, double-blind, placebo-controlled, parallel arm trial with 132 healthy overweight adults showed that NR doses of 100, 300 and 1000 mg all increased blood levels of NAD+, with no safety issues identified. The results are published in the journal Scientific Reports.
The 300 mg dose is the recommended daily serving of Tru Niagen in the United States, and the new study indicated that this dose raised NAD+ levels by 51% within two weeks.
“This is a timely publication in the history of Niagen as it clearly shows safe, dose-dependent and time-dependent increases in blood NAD in human populations,” said Charles Brenner, PhD, Roy J. Carver Chair & Head of Biochemistry at the University of Iowa & ChromaDex Chief Scientific Advisor.
“With so much global interest in NAD-boosting supplementation strategies, our approach to human translation has been to put safety first. These data will be used to design the next generation of trials to promote wellness as well as to test the activity of Niagen against diseases and conditions of metabolic stress.”
NR is found naturally in trace amounts in milk and other foods, and is a more potent, no-flush version of niacin (vitamin B3). Published research has shown that NR is a potent precursor to NAD+ in the mitochondria of animals. NAD+ is an important cellular co-factor for improvement of mitochondrial performance and energy metabolism.
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 also can be depleted by lifestyle choices such as overeating and lack of exercise. By boosting NAD+, NR may increase mitochondrial health and induce the creation of new mitochondria.
Irvine, CA-based Chromadex has been accumulating the IP surrounding NR for a couple of years, having licensed patents from Cornell University, Dartmouth College, and Washington University in St Louis.
For the new study, Dr Brenner and co-workers from Chromadex Spherix Consulting conducted eight week interventions with healthy overweight adults randomly assigned to consume Niagen doses of 0 mg (placebo), 100 mg, 300 mg, or 1,000 mg per day.
Results showed that the three Niagen doses led to statistically significant increases in blood NAD+ levels of 22%, 51% and 142%, respectively.
NutraIngredients-USA Award Winner
ChromaDex's Tru Niagen was the winner of the 2019 NutraIngredients-USA Award for Healthy Aging Ingredient of the Year.
In addition, no changes in LDL cholesterol levels or blood levels of homocysteine were observed at the end of the study.
“The safe oral availability of NR and its lack of adverse effects on [homocysteine] and LDL-[cholesterol] at doses up to 1000 mg/day support the establishment of [an upper limit] for NR that is equal to or greater than that of [nicotinamide],” concluded the researchers.
Commenting on the study’s findings, Matthew Roberts, PhD, ChromaDex’s CSO, said: “This clinical study builds upon a body of research demonstrating the safe and sustained benefits of Niagen supplementation, and importantly identifies optimal dosing to achieve increased NAD levels over time.”
ChromaDex CEO Rob Fried added: “The results of this large human trial directly support the efficacy and safety of our NAD-boosting consumer product Tru Niagen. The study also provides key data points for regulatory submissions as we continue our global expansion.”
ChromaDex is working with over 160 research institutions around the world, which represents over $50 million of research paid for by third parties, and this includes 33 ongoing clinical trials.
The ingredient is supported by two successful NDI notifications (NDIN 882 in 2015 and NDIN 1062 in 2018), as well as a successful GRAS notification (GRN 635).
ChromaDex is now pursuing reg approval for Niagen in EU, Australia, Japan, and several other countries.
Source: Scientific Reports
2019, Volume 9, Article number: 9772
“Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults”
Authors: D. Conze, C. Brenner, C.L. Kruger