Clinical study affirms Niagen nicotinamide riboside ingredient’s long-term safety, optimal dosing

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ChromaDex (Los Angeles) announced a recently published clinical study affirming the safe use of the company’s Niagen nicotinamide riboside (NR) ingredient. NR is a member of the vitamin B3 family and plays a role in the production of nicotinamide adenine dinucleotide (NAD+), “an essential molecule found in every living cell,” the company says.

The new randomized, double-blind, placebo-controlled, parallel-arm study¹ published in Scientific Reports explored the safety of chronic Niagen supplementation as well as the level of dosing required to sustainably increase blood NAD+ levels. The eight-week study, conducted in 132 healthy overweight adults, is the largest trial conducted on Niagen to date and the first to “measure kinetic and dose-dependent effects of chronic NR supplementation” and demonstrate “safety and optimal dosing levels critical for validation in ongoing research,” ChromaDex said in a press release.

In the study, subjects were given either placebo, 100 mg, 300 mg, or 1000 mg of Niagen NR daily for eight weeks. According to researchers: “Consumption of 100, 300, and 1000 mg [of] NR dose-dependently and significantly increased whole blood NAD+ (i.e., 22%, 51%, and 142%) and other NAD+ metabolites within two weeks. The increases were maintained throughout the remainder of the study. There were no reports of flushing and no significant differences in adverse events between the NR and placebo-treated groups or between groups at different NR doses. NR also did not elevate low-density lipoprotein cholesterol or dysregulate 1-carbon metabolism.”

The researchers said the data in the study support establishing a tolerable upper intake limit for Niagen NR. “Here," the wrote, "we show that once-a-day doses of NR up to 1 gram per day are safe and orally available.”

ChromaDex points out that this limit is unique: “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.”

Niagen is the ingredient in ChromaDex’s Tru Niagen retail supplement. This study supports the safe use of the supplement’s recommended dose, which is 300 mg daily. In this study, participants who consumed 300 mg/day of Niagen saw a significant 51% increase in whole-blood NAD+ within two weeks that lasted throughout the eight-week study.

“The results of this large human trial directly support the efficacy and safety of our NAD-boosting consumer product Tru Niagen,” says ChromaDex CEO Rob Fried. “The study also provides key data points for regulatory submissions as we continue our global expansion.”

“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 and Head of Biochemistry at the University of Iowa and ChromaDex’s chief scientific advisor, in a press release. “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.”

ChromaDex points out that Niagen is the only commercially available NR ingredient that has been twice successfully reviewed under FDA’s new dietary ingredient (NDI) notification process and also has undergone Generally Recognized as Safe (GRAS) notification to FDA.

References:

1. Conze D et al. “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. Scientific Reports, vol. 9, no. 1 (July 5, 2019): 9972