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

NCT07469527 | Recruiting

• 1 other identifier: B05-25-02-T0083
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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

Keywords

Stress Control; Anxiety; Relaxation

Outcome Measures

Primary Outcomes (1)

• Change 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.

  Baseline (Day 1) to Day 29

Secondary Outcomes (17)

• Change in State-Trait Anxiety Inventory - State (STAI-S) - Single Dose

  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

  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

  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

  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)

  Day 1 to Day 29

Other Outcomes (125)

• PK Profile of Mitragynine AUC0-8 (Single Dose)

  Day 1 (0-8 hours)

• PK Profile of Mitragynine AUC8-24 (Single Dose)

  Day 1-Day 2 (8-24 hours)

• PK Profile of Mitragynine AUC0-24 (Single Dose)

  Day 1-Day 2 (0-24 hours)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

No Active Product per bottle

Other: Placebo

Feel Free Classic Tonic Dose 1

EXPERIMENTAL

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

Other: Kava and Kratom Herbal Supplement

Feel Free Classic Tonic Dose 2 (half strength)

EXPERIMENTAL

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

Other: Kava and Kratom Herbal Supplement

Interventions

Placebo OTHER

Placebo

Placebo

Kava and Kratom Herbal Supplement OTHER

Feel Free Classic Tonic Dose 1 (TP1)

Feel Free Classic Tonic Dose 1

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Agree to use acceptable contraceptive methods.
• Agree to abstain from alcohol consumption for the entire duration of the study.
• 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.
• For Sub-Study participants only:
• Must have suitable veins for repeated venipuncture.
• Willing and able to attend video conference calls with study coordinators.

You may not qualify if:

• 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.
• 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).
• High BP at the Screening or Baseline Visit (≥140 systolic or ≥90 diastolic mmHg)
• Have low BP (\<90 systolic or \<60 diastolic mmHg) at Baseline unless deemed clinically insignificant by the investigator and the participant is asymptomatic.
• Have a history of heart disease, blood clotting disorders, renal or hepatic impairment/disease, or liver injury.
• Have known genetic polymorphisms of CYP450, CYP3A4, CYP2D6, and/or CYP1A2 enzymes.
• Individuals with active asthma or have experienced an asthma attack in the last 5 years.
• Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
• 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.

Sponsors & Collaborators

• Botanic Tonics, LLC: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

ApexTrials

Guelph, Ontario, N1G 0B4, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ramsey Atallah

  Botanic Tonics

  STUDY DIRECTOR

Central Study Contacts

Ambreen Atif, MD

CONTACT

519-341-3367; aatif@nutrasource.ca

Stephanie Recker

CONTACT

519-341-3367; srecker@nutrasource.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 13, 2026
• Study Start: March 7, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 14, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)