Niagen Bioscience Enters Start-Up Agreement With Mass General Brigham To Plan The Largest And Most Comprehensive Clinical Trial Of Niagen To Date

As an investigator-led study, MGB is developing the proposed trial in collaboration with the Niagen Research Program, the Company’s external research program supporting independent and collaborative research on food-grade and pharmaceutical-grade Niagen and other precursors. The prospective, randomized, placebo-controlled clinical trial is designed to evaluate Niagen's short- and long-term effects on major clinical and healthy aging outcomes and related biomarkers in a large number of apparently healthy adults aged 50 and older.In addition to the two founding collaborators, MGB and Niagen Bioscience, the initiative seeks interest from other academic, nonprofit, philanthropic, and industry organizations aligned with the project's scientific goals and willing to contribute meaningful expertise or resources to support trial planning and execution."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, Division of Preventive Medicine, Brigham and Women’s Hospital and Associate Professor of Medicine, 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."Outcomes under consideration include major morbidity and mortality; functional measures of Intrinsic Capacity (IC), such as physical activity, cognition, and fatigue; wellness outcomes such as energy and sleep; and biomarker-based measures related to biological aging, inflammation, and NAD+ status. Final trial design elements such as sample size, supplemental dose, duration, clinical endpoints, regulatory review, and logistics remain subject to ongoing planning, budgeting, and final agreements.The proposed trial will build on prior large-scale nutrition and prevention research and clinical trials spearheaded by Dr. Sesso and colleagues at the Brigham and Women’s Hospital Division of Preventive Medicine while incorporating advances in biomarker science and innovative assessments of healthy aging. This trial design is expected to maximize the investment's scientific value by enabling researchers to evaluate multiple relevant endpoints within one integrated trial framework.Through the Niagen Research Program, independent investigators from world-renowned institutions have historically requested Niagen for pre-clinical and clinical research on NAD+ biology. The program provides oral food-grade and pharmaceutical-grade Niagen research materials, scientific collaboration, and technical support. To date, more than 45 peer-reviewed clinical studies have been published on Niagen, and the program supports more than 175 ongoing and developing research studies.Niagen stands out in the NAD+ category for its extensive human clinical research, patented nicotinamide riboside technology, rigorous quality protocols, and established scientific standards. Earlier this year, nicotinamide riboside chloride, the patented form of NR in Niagen, became the first among NR, NMN, and NAD+ to receive a published United States Pharmacopeia dietary supplement ingredient monograph, establishing an independent quality benchmark for NRCl.