Actively Recruiting
Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults
Led by Botanic Tonics, LLC · Updated on 2026-05-01
165
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
Sponsors
B
Botanic Tonics, LLC
Lead Sponsor
N
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 55 years at screening
- Self-reported stress with a PSS-10 score between 14 and 26 at screening and baseline
- Good general health with no uncontrolled diseases and able to consume the study product
- Limited use (3 or fewer times in past 3 months) of nicotine, kava, and kratom products, and willing to abstain 14 days before baseline and during the study
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 at screening and baseline
- Agree to follow restrictions on treatments and lifestyle during the study
- Maintained consistent diet, supplements, and lifestyle for 3 months before screening and agree to maintain them
- Agree to use acceptable contraceptive methods
- Agree to abstain from alcohol during the entire study
- Willing and able to consent, understand questionnaires, and complete study procedures
- For sub-study participants: have suitable veins for repeated blood draws and able to attend video calls
You will not qualify if you...
- Lactating, pregnant, or planning pregnancy during the study
- Known allergy or intolerance to study products or rescue medication
- Positive urine drug screen, positive urine cotinine, or positive breath alcohol test at screening or baseline
- Abnormal respiratory rate or oxygen saturation at screening or baseline
- Elevated liver enzymes (ALT, AST, ALP, GGT, total bilirubin) at or above twice the upper limit of normal
- Currently enrolled in another clinical trial or used investigational products within 28 days before baseline
- Gastrointestinal abnormalities that affect swallowing or digestion
- Diagnosis of Type I or II diabetes or thyroid disease
- High blood pressure (60/90 mmHg) or low blood pressure (<90/60 mmHg) unless asymptomatic and clinically insignificant
- History of heart disease, blood clotting disorders, kidney or liver impairment
- Known genetic polymorphisms affecting liver enzymes CYP450, CYP3A4, CYP2D6, or CYP1A2
- Active asthma or asthma attack in last 5 years
- Treatment for or hospitalization due to psychiatric disorders in past 12 months
- History of cancer (except certain skin or cervical cancers) with recovery within 5 years
- Significant blood donation or loss within specified recent timeframes
- Major surgery within 3 months before screening or planned during the study
- History of alcohol or substance abuse, including kratom
- Evidence of addictive tendencies (LDQ score 21)
- Use of anxiolytic or sleep aids in 4 weeks before baseline
- Consumption of more than two standard alcoholic drinks per day in past 4 weeks
- Excessive caffeine intake over 500 mg per day
- Other medical conditions or treatments that may affect study participation or data quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ApexTrials
Guelph, Ontario, Canada, N1G 0B4
Actively Recruiting
Research Team
A
Ambreen Atif, MD
CONTACT
S
Stephanie Recker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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