Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults (NCT07469527) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults
Canada165 participantsStarted 2026-03-07
Plain-language summary
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.
Who can participate
Age range21 Years – 55 Years
SexALL
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Inclusion criteria
✓. Adults who are between 21 - 55 years of age (inclusive) at screening.
✓. Have self-reported stress at screening and baseline scoring 14 - 26 (inclusive) on the PSS-10.
✓. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product.
✓. Not currently using, defined as ≤ 3 uses in the past 3 months prior to Baseline, any nicotine containing products (patches, gums, vapes etc.), kava products, and/or kratom products, and willing to abstain starting 14 days prior to Baseline and throughout the study.
✓. Have a BMI range of 18.5 - 29.9 kg/m2 at screening and baseline.
✓. Agree to follow the restrictions on concomitant treatments.
✓. Agree to follow the restrictions on lifestyle.
✓. Have maintained consistent dietary habits, including supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study.
Exclusion criteria
✕. Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test during study visits.
✕. Have a known sensitivity, intolerability, or allergy to any of the study products, their excipients, or rescue medication.
✕. Demonstrates a positive urine drug screen test for compounds listed in Table 9 Screening or Baseline visits, a positive urine cotinine test at the Screening or Baseline visits, or a positive breath alcohol test at Baseline visit.
What they're measuring
1
Change in Perceived Stress Scale-10 (PSS-10) Score
✕. Have abnormal RR or SpO2 measurements at Screening or Baseline at the discretion of the investigator.
✕. Screening laboratory results showing liver enzyme levels \[Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), Gamma-Glutamyl Transferase (GGT), total bilirubin\] ≥ 2 times the upper limit of normal, or any other clinically significant abnormal safety laboratory values as per the Investigator's discretion.
✕. Is currently enrolled in another clinical trial or has received/used an investigational product in another research study within 28 days before baseline.
✕. Individuals with an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
✕. Have Type I/Type II diabetes or thyroid disease (thyroid function to be assessed by TSH, T3, and T4 levels at Screening visit).