This study is being conducted to assess the effects of the Feel Free® Classic Tonic on stress in healthy adults. The goal is to see whether the tonic can help reduce self-perceived and physiological stress and provide information on how its ingredients are processed in the body.
This is a randomized, double-blind, parallel, 3-arm, placebo-controlled study to assess the effects of two dose levels of the Feel Free® Classic Tonic on stress in healthy adults. The primary goal is to evaluate how the tonic affects self-reported and physiological measures of stress and anxiety. A pharmacokinetic sub-study will assess how the tonic's components are absorbed and processed. The tonic contains kava and kratom, botanicals traditionally used for relaxation and mood support, and early data suggest it is generally well tolerated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
165
Placebo
Feel Free Classic Tonic Dose 1 (TP1)
Feel Free Classic Tonic Dose 2 (TP2 - Half Strength)
ApexTrials
Guelph, Ontario, Canada
RECRUITINGChange in Perceived Stress Scale-10 (PSS-10) Score
Change in PSS-10 score from baseline to Day 29 to assess the effect of the test product on self-perceived stress. Items are scored on a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Higher scores indicate higher perceived stress levels.
Time frame: Baseline (Day 1) to Day 29
Change in State-Trait Anxiety Inventory - State (STAI-S) - Single Dose
Change in STAI-S score from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic \[pre-TSST-A\]) on Day 1 after a single dose. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a higher anxiety.
Time frame: Day 1 pre-dose to Day 1 post-dose (pre-TSST-A)
Change in State-Trait Anxiety Inventory - State (STAI-S) During TSST-A (Trier Social Stress Test - Arithmetic) - Single Dose
Change in STAI-S score from pre-TSST-A to post-TSST-A at 0, 15, 25, and 55 minutes on Day 1. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a worse outcome.
Time frame: Day 1 assessments at pre-TSST-A, and post-TSST-A at 0, 15, 25, 55 minutes
Change in State-Trait Anxiety Inventory - State (STAI-S) - Multiple-Day Dosing
Change in STAI-S score from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic \[pre-TSST-A\]) on Day 29 after a single dose. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a worse outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 29 pre-dose to Day 29 pre-TSST-A
Change in State-Trait Anxiety Inventory - State (STAI-S) During TSST-A (Trier Social Stress Test - Arithmetic) - Multiple-Day Dosing
Change in STAI-S score from pre-TSST-A to post-TSST-A at 0, 15, 25, and 55 minutes on Day 29. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a worse outcome.
Time frame: Day 29 measurements at pre-TSST-A, and post-TSST-A at 0, 15, 25 and 55 minutes.
Change in State-Trait Anxiety Inventory - Trait (STAI-T)
Change in STAI-T score from pre-dose Day 1 to pre-dose Day 29. The scale assesses how respondents feel "generally". It measures relatively stable individual differences in anxiety proneness. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a higher anxiety.
Time frame: Day 1 to Day 29
Physiological Stress Markers (Cortisol) - Single Dose
Change in salivary cortisol (µg/dL) from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic \[pre-TSST-A\]) on Day 1.
Time frame: Day 1
Physiological Stress Markers (Alpha-Amylase) - Single Dose
Change in alpha-amylase (U/mL) from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic \[pre-TSST-A\]) on Day 1
Time frame: Day 1
Physiological Stress Markers (Cortisol) During Trier Social Stress Test - Arithmetic (TSST-A) - Single Dose
Change in salivary cortisol (µg/dL) from pre-TSST-A to 10, 20, 30, and 60 minutes post-TSST-A
Time frame: Day 1
Physiological Stress Markers (Alpha-Amylase) During Trier Social Stress Test - Arithmetic (TSST-A) - Single Dose
Change in salivary alpha-amylase (U/mL) from pre-TSST-A to 10, 20, 30, and 60 minutes post-TSST-A
Time frame: Day 1
Physiological Stress Markers (Heart Rate) During Trier Social Stress Test - Arithmetic (TSST-A) - Single Dose
Change in heart rate (bpm) from pre-TSST-A to 60 minutes post-TSST-A.
Time frame: Day 1
Physiological Stress Markers (Cortisol) - Multiple-Day Dose
Change in salivary cortisol (µg/dL) from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic \[pre-TSST-A\]) on Day 29.
Time frame: Day 29
Physiological Stress Markers (Alpha-Amylase) - Multiple-Day Dose
Change in salivary alpha-amylase (U/mL) from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic \[pre-TSST-A\]) on Day 29.
Time frame: Day 29
Physiological Stress Markers (Cortisol) During Trier Social Stress Test - Arithmetic (TSST-A) - Multiple-Day Dosing
Change in salivary cortisol (µg/dL) from pre-TSST-A to 10, 20, 30, and 60 minutes post-TSST-A.
Time frame: Day 29
Physiological Stress Markers (Alpha-Amylase) During Trier Social Stress Test - Arithmetic (TSST-A) - Multiple-Day Dosing
Change in salivary alpha-amylase (U/mL) from pre-TSST-A to 10, 20, 30, and 60 minutes post-TSST-A
Time frame: Day 29
Physiological Stress Markers (Heart Rate) During Trier Social Stress Test - Arithmetic (TSST-A) - Multiple-Day Dosing
Change in heart rate (bpm) from pre-TSST-A to 60 minutes post-TSST-A.
Time frame: Day 29
Awakening Cortisol Response
Change in morning awakening salivary cortisol over 30 minutes from baseline to Day 29.
Time frame: Baseline Day 1 to Day 29
Awakening Alpha-Amylase Response
Change in morning awakening alpha-amylase over 30 minutes from baseline to Day 29
Time frame: Baseline Day 1 to Day 29