Investigational product
The investigational product was food-grade NMN bulky powder with the brand name “AbinoNutra™NMN,” which was developed and manufactured by Aba Chemicals Co., Ltd. (Shanghai, China) in collaboration with Abinopharm, Inc. (Connecticut, USA) on manufacturing process development, quality control, and regulatory compliance. The two companies co-sponsored this human clinical trial. The NMN bulky powder was packed into capsules containing 150 mg NMN/capsule by Polifarma (Nanjing, China). Placebo was also produced by Polifarma as capsules of the same make, size, shape, and opaque white color filled with 150 mg/capsule rice flour. Both NMN and placebo capsules were shipped to the site of ProRelix Services, the CRO (Pune, India). The CRO did the blinding by packing the NMN or placebo capsules into opaque bottles that all labeled the same as “NMN or placebo”. Each bottle was then placed into a coded kit. A statistician at the CRO company did the randomization to evenly divide the 80 participants into 4 groups for placebo, 300 mg, 600 mg, and 900 mg NMN with 20 participants per group. The randomization code was generated and digitally locked in CRO’s database by the statistician. The statistician was the only person who was able to access and decode the randomization list.Trial staff at the two clinical centers allocated these coded kits to participants and instructed participants to take two capsules [300 mg NMN (Trial flow for evaluating efficacy and safety of β-nicotinamide mononucleotide (AbinoNutra™NMN). Each recruited participant was instructed to take the assigned amount of either placebo or NMN orally once a day before breakfast with water of ambient temperature for 60 days. PO = orally, QD = once daily dosing. *Due to 1 participant each from placebo and 900 mg groups did not fast, Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) was based on 19 participants for these two groups