Randomized Study of Feel Free Classic Tonic Effects on Stress and How Its Ingredients Are Processed in Healthy Adults Aged 21 to 55

What this Trial Is About

Researchers are evaluating the effects of Feel Free Classic Tonic, a herbal supplement containing kava and kratom, on stress and anxiety in healthy adults aged 21 to 55. This randomized, double-blind, placebo-controlled study aims to understand how the tonic influences self-reported stress, physiological stress markers, and how its ingredients are absorbed and processed in the body through a pharmacokinetic sub-study. Participants are randomly assigned to one of three groups a placebo group, a group receiving a higher dose of the tonic 380 mg Kava root extract and 1480 mg dried Kratom leaf powder per bottle, or a group receiving a half-strength dose 190 mg Kava root extract and 740 mg dried Kratom leaf powder per bottle. The study compares these groups over 29 days, including single and multiple-day dosing periods. During the study, participants will complete questionnaires like the Perceived Stress Scale-10 and State-Trait Anxiety Inventory to assess stress and anxiety levels. Researchers will also measure physiological markers such as cortisol, alpha-amylase, and heart rate, especially during the Trier Social Stress Test-Arithmetic. Participants must follow lifestyle and diet restrictions, abstain from alcohol, and may attend video calls for coordination. The primary outcome is the change in perceived stress from baseline to day 29, with various secondary measures tracking anxiety and physiological stress responses.

Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults