“The results of this large human trial directly support the efficacy and safety of our NAD-boosting consumer product Tru Niagen,” said ChromaDex CEO Rob Fried. “The study also provides key data points for regulatory submissions as we continue our global expansion.”
This is the first clinical trial to measure both the kinetics and dose-dependent effects of chronic Niagen supplementation, according to the company; 132 healthy overweight adults completed the randomized, double-blind, placebo-controlled, parallel arm trial. The results showed how supplementation with three different daily doses of Niagen (100 mg, 300 mg, 1,000 mg) initially increase and then sustain elevated blood NAD levels over the course of an 8-week period.
The results of this study support the NAD-boosting efficacy of Tru Niagen, which recommends a daily serving size of 300 mg in the U.S. On average, study participants consuming 300 mg/day experienced a statistically significant 51% increase in whole blood NAD+ within two weeks. This increase was maintained throughout the remainder of the eight-week study.
The study also joins previous chronic supplementation studies to support the safety of chronic Niagen supplementation. All doses tested were well-tolerated with no attributable adverse events reported. By the end of the eight-week trial, no changes in LDL cholesterol levels or blood levels of homocysteine were observed. These results further differentiate Niagen from other NAD-boosting supplements and support the establishment of a unique upper limit for Niagen versus other B3 vitamins, the company said.
“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.”
“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,” said Matthew Roberts, PhD, chief scientific officer, ChromaDex.
To date, ChromaDex has invested millions of dollars in safety and human clinical trials on its patent-protected NR (commercially known as Niagen) and has entered research agreements with more than 160 institutions for research, including Dartmouth, the National Institutes of Health, University of Iowa, and the Scripps Research Institute.
NIAGEN is the only commercially available nicotinamide riboside which has twice been reviewed under FDA's new dietary ingredient (NDI) notification program and has also been successfully notified to the FDA as generally recognized as safe (GRAS).