Los Angeles — Niagen Bioscience announced a start-up agreement with Mass General Brigham to begin planning a large, multi-year clinical trial evaluating nicotinamide riboside supplementation in adults ages 50 and older.
The proposed randomized, placebo-controlled prevention trial would study Niagen, the company’s patented form of nicotinamide riboside, or NR, across a range of clinical outcomes, healthy aging measures and biomarkers.
“This agreement reflects the next stage of responsible NAD+ science,” said Rob Fried, Chief Executive Officer of Niagen Bioscience. “As NAD+ continues to gain mainstream attention, a larger, longer, well-designed trial is needed to study the preventative, long term benefits of this remarkable ingredient, Niagen.”
Fried said large, long-term studies have helped establish confidence in widely used products such as multivitamins, fish oil and vitamin D, and said the company believes Niagen should undergo similar evaluation.
The investigator-led study is being developed by Mass General Brigham in collaboration with the Niagen Research Program, which supports independent and collaborative research involving food-grade and pharmaceutical-grade Niagen and other NAD+ precursors.
The proposed trial would evaluate both short- and long-term effects of Niagen supplementation in a large group of apparently healthy adults ages 50 and older.
Researchers are considering outcomes including major morbidity and mortality, physical activity, cognition, fatigue, energy, sleep, biological aging, inflammation and NAD+ status.
Final details, including the number of participants, supplemental dose, trial duration, clinical endpoints, regulatory review and logistics, remain under development.
“Large-scale prevention trials are essential to understanding how nutrition interventions definitively impact clinically meaningful outcomes over time,” said Howard Sesso, ScD, MPH, Associate Director of the Division of Preventive Medicine at Brigham and Women’s Hospital and Associate Professor of Medicine at Harvard Medical School.
“Our unique hybrid randomized trial design will allow us to evaluate Niagen supplementation that combines clinical, functional, and wellness outcomes with novel biomarker measures and other innovative assessments relevant to aging biology and mechanisms of effect in subsets of participants,” Sesso added.
Niagen Bioscience and Mass General Brigham are also seeking participation from academic, nonprofit, philanthropic and industry organizations that could contribute scientific expertise or resources to the project.
The proposed study would build on previous large-scale nutrition and prevention trials led by Sesso and colleagues at Brigham and Women’s Hospital while incorporating newer biomarker and healthy aging assessments.
Niagen Bioscience said more than 45 peer-reviewed clinical studies involving Niagen have been published, while its research program supports more than 175 ongoing or developing studies.
Earlier this year, nicotinamide riboside chloride, the patented form of NR used in Niagen, became the first among NR, NMN and NAD+ to receive a published United States Pharmacopeia dietary supplement ingredient monograph, according to the company.
