Recruiting

Feel Free® Classic Tonic

Sponsor:

Botanic Tonics, LLC

Code:

NCT07469527

Conditions

Anxiety

Physiological Stress

Stress

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Placebo

Kava and Kratom Herbal Supplement

Kava and Kratom Herbal Supplement

Study Details

Brief 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.

Conditions

Anxiety

Physiological Stress

Stress

Study ID

NCT07469527

Start date

Mar 7, 2026

Status verified date

Apr, 2026

Completion date

Oct 14, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Adults who are between 21 - 55 years of age (inclusive) at screening.
2. Have self-reported stress at screening and baseline scoring 14 - 26 (inclusive) on the PSS-10.
3. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product.
4. 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.
5. Have a BMI range of 18.5 - 29.9 kg/m2 at screening and baseline.
6. Agree to follow the restrictions on concomitant treatments.
7. Agree to follow the restrictions on lifestyle.
8. 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.
9. Agree to use acceptable contraceptive methods.
10. Agree to abstain from alcohol consumption for the entire duration of the study.
11. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
12. For Sub-Study participants only:

  • Must have suitable veins for repeated venipuncture.
  • Willing and able to attend video conference calls with study coordinators.

Exclusion Criteria:

1. Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test during study visits.
2. Have a known sensitivity, intolerability, or allergy to any of the study products, their excipients, or rescue medication.
3. 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.
4. Have abnormal RR or SpO2 measurements at Screening or Baseline at the discretion of the investigator.
5. 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.
6. Is currently enrolled in another clinical trial or has received/used an investigational product in another research study within 28 days before baseline.
7. 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).
8. Have Type I/Type II diabetes or thyroid disease (thyroid function to be assessed by TSH, T3, and T4 levels at Screening visit).
9. High BP at the Screening or Baseline Visit (≥140 systolic or ≥90 diastolic mmHg)
10. Have low BP (<90 systolic or <60 diastolic mmHg) at Baseline unless deemed clinically insignificant by the investigator and the participant is asymptomatic.
11. Have a history of heart disease, blood clotting disorders, renal or hepatic impairment/disease, or liver injury.
12. Have known genetic polymorphisms of CYP450, CYP3A4, CYP2D6, and/or CYP1A2 enzymes.
13. Individuals with active asthma or have experienced an asthma attack in the last 5 years.
14. Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
15. Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurring within 5 years before the screening visit.
16. Reports significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days before baseline or a blood donation of more than 450 mL within 56 days before baseline.
17. Reports donating plasma (e.g., plasmapheresis) within 15 days before baseline.
18. Major surgery in 3 months before screening or planned major surgery during the study.
19. History of alcohol or substance abuse (e.g., opioids, kratom) (including having been hospitalized for such an in-patient or out-patient intervention program).
20. Evidence of addictive tendency as indicated by an LDQ score ≥21.
21. Use of anxiolytic or sleep aids (natural health products or drugs) in the 4 weeks before baseline.
22. Currently consumes more than two (2) standard alcoholic beverages per day on average for 4 weeks.

Note: A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.
23. Excessive caffeine intake, defined as habitual consumption of >500 mg per day.
24. Any other medical conditions or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures, pose a significant risk to the participant or compromise the quality of study data.

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

No Active Product per bottle

experimental: Feel Free Classic Tonic Dose 1

Active Product of 380 mg Kava root extract and 1480 mg of dried Kratom Leaf powder per bottle

experimental: Feel Free Classic Tonic Dose 2 (half strength)

Active Product of 190 mg Kava root extract and 740 mg of dried Kratom Leaf powder per bottle

Interventions

Placebo

Placebo

Kava and Kratom Herbal Supplement

Feel Free Classic Tonic Dose 1 (TP1)

Kava and Kratom Herbal Supplement

Feel Free Classic Tonic Dose 2 (TP2 - Half Strength)

Primary outcome measure

  • Change in Perceived Stress Scale-10 (PSS-10) Score [ Time Frame: Baseline (Day 1) to Day 29 ]

Central Contacts and Locations

Central contacts

Locations

ApexTrials

Recruiting

Guelph, Ontario, Canada, N1G 0B4

Contacts

Katie Keene, H.BSc., CCRP

226-706-2545kkeene@apextrials.com

Principal Investigator:

Anthony Bier, MD, CCFP(EM)

More Information

Sponsor

Botanic Tonics, LLC

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Stress Control
  • Anxiety
  • Relaxation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Botanic Tonics, LLC on 2026-05-01.