Safety, Tolerability, and Pharmacokinetics of an Oral Withania Somnifera Product in Older Adults

This is a single-blind, crossover trial evaluating (a) the pharmacokinetics of withanolides from two doses (120 and 240 mg) of a commercially available Withania somnifera root and leaf extract (Shoden®), (b) the safety and tolerability of these doses over four weeks' use and (c) the feasibility of remotely measuring sleep- and stress-related outcomes in older adults. There will be two four-week study periods separated by a two-week washout period. During each study period, participants will attend a 13-hour pharmacokinetics study visit, where they will receive a single dose of either 120 or 240 mg Shoden®, and return for 24- and 48-hour blood and urine collections. After the 48-hour visit, they will continue taking Shoden® at the administered dose (120 or 240 mg) for four weeks, at which time they will return for a follow-up visit.