Study Comparing How Fisetin Is Processed in Healthy Young Adults 18-30 years and Older Adults 65 years and up

What this Trial Is About

Researchers are evaluating how fisetin, a dietary supplement, behaves in the body of healthy adults in two age groups young adults aged 18 to 30 years and older adults aged 65 years or older. The study aims to describe the kinetics of fisetin after a single oral dose in older adults and to compare these kinetics between young and old age groups. This trial is designed as an open-label, four-arm, cross-over study involving fasted and fed conditions to assess differences in fisetin absorption and metabolism. Participants will receive a single oral dose of 500 mg fisetin as capsules with water either after overnight fasting or following a high-caloric, high-fat meal recommended by the FDA for food-effect studies. Each participant will complete all four arms in random order with at least a one-week washout period between arms. The fed meal includes toast with butter, fried eggs, hash brown potatoes, and whole milk. Urine collection and blood sampling will be conducted to measure fisetin and its metabolites. During each kinetic visit, 24 blood samples will be drawn over 10 hours to track fisetin levels in plasma, with a total blood volume of 164 ml per arm. Participants will stay in the clinical research unit for 10 hours post-dose, during which blood pressure and heart rate will be monitored for the first 4 hours. They will also drink sparkling water hourly to aid digestion. Urine will be collected for 10 hours after dosing to assess fisetin excretion. The studys main outcomes focus on fisetin plasma concentrations under different conditions and across age groups.

A Comparison of Fisetin Kinetics in Young and Old Adults