Status
Conditions
Treatments
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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.
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:
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.
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.
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.
Reports donating plasma (e.g., plasmapheresis) within 15 days before baseline.
Major surgery in 3 months before screening or planned major surgery during the study.
History of alcohol or substance abuse (e.g., opioids, kratom) (including having been hospitalized for such an in-patient or out-patient intervention program).
Evidence of addictive tendency as indicated by an LDQ score ≥21.
Use of anxiolytic or sleep aids (natural health products or drugs) in the 4 weeks before baseline.
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.
Excessive caffeine intake, defined as habitual consumption of >500 mg per day.
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.
Primary purpose
Allocation
Interventional model
Masking
165 participants in 3 patient groups, including a placebo group
Loading...
Central trial contact
Stephanie Recker; Ambreen Atif, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal