AnxietyNCT07469527
Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults
A study testing Kava and Kratom Herbal Supplement in people with Anxiety and Physiological Stress, run by Botanic Tonics, LLC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Physiological Stress, Stress
- What is being tested?
- Kava and Kratom Herbal Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2026to 14 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
ApexTrials
Guelph, Ontario, N1G 0B4
Katie Keene, H.BSc., CCRP, 226-706-2545, kkeene@apextrials.com
Anthony Bier, MD, CCFP(EM)
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of Feel Free® Classic Tonic on Self-Perceived Stress and Pharmacokinetic Profile in Healthy Adults
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.
Read the detailed 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.
- Conditions
- Anxiety, Physiological Stress, Stress
- Being tested
- Placebo, Kava and Kratom Herbal Supplement
- Keywords
- Stress Control, Anxiety, Relaxation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo
Kava and Kratom Herbal SupplementOther
Feel Free Classic Tonic Dose 1 (TP1)
Kava and Kratom Herbal SupplementOther
Feel Free Classic Tonic Dose 2 (TP2 - Half Strength)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | No Active Product per bottle Receives: 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 Receives: 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 Receives: Other: Kava and Kratom Herbal Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) to Day 29
Secondary outcomes (17)
Change in State-Trait Anxiety Inventory - State (STAI-S) - Single Dose
Change in STAI-S score from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic [pre-TSST-A]) on Day 1 after a single dose. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a higher anxiety.
Measured: 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
Change in STAI-S score from pre-TSST-A to post-TSST-A at 0, 15, 25, and 55 minutes on Day 1. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a worse outcome.
Measured: 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
Change in STAI-S score from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic [pre-TSST-A]) on Day 29 after a single dose. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a worse outcome.
Measured: 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
Change in STAI-S score from pre-TSST-A to post-TSST-A at 0, 15, 25, and 55 minutes on Day 29. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a worse outcome.
Measured: 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)
Change in STAI-T score from pre-dose Day 1 to pre-dose Day 29. The scale assesses how respondents feel "generally". It measures relatively stable individual differences in anxiety proneness. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a higher anxiety.
Measured: Day 1 to Day 29
Physiological Stress Markers (Cortisol) - Single Dose
Change in salivary cortisol (µg/dL) from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic [pre-TSST-A]) on Day 1.
Measured: Day 1
Physiological Stress Markers (Alpha-Amylase) - Single Dose
Change in alpha-amylase (U/mL) from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic [pre-TSST-A]) on Day 1
Measured: Day 1
Physiological Stress Markers (Cortisol) During Trier Social Stress Test - Arithmetic (TSST-A) - Single Dose
Change in salivary cortisol (µg/dL) from pre-TSST-A to 10, 20, 30, and 60 minutes post-TSST-A
Measured: Day 1
Physiological Stress Markers (Alpha-Amylase) During Trier Social Stress Test - Arithmetic (TSST-A) - Single Dose
Change in salivary alpha-amylase (U/mL) from pre-TSST-A to 10, 20, 30, and 60 minutes post-TSST-A
Measured: Day 1
Physiological Stress Markers (Heart Rate) During Trier Social Stress Test - Arithmetic (TSST-A) - Single Dose
Change in heart rate (bpm) from pre-TSST-A to 60 minutes post-TSST-A.
Measured: Day 1
Physiological Stress Markers (Cortisol) - Multiple-Day Dose
Change in salivary cortisol (µg/dL) from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic [pre-TSST-A]) on Day 29.
Measured: Day 29
Physiological Stress Markers (Alpha-Amylase) - Multiple-Day Dose
Change in salivary alpha-amylase (U/mL) from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic [pre-TSST-A]) on Day 29.
Measured: Day 29
Physiological Stress Markers (Cortisol) During Trier Social Stress Test - Arithmetic (TSST-A) - Multiple-Day Dosing
Change in salivary cortisol (µg/dL) from pre-TSST-A to 10, 20, 30, and 60 minutes post-TSST-A.
Measured: Day 29
Physiological Stress Markers (Alpha-Amylase) During Trier Social Stress Test - Arithmetic (TSST-A) - Multiple-Day Dosing
Change in salivary alpha-amylase (U/mL) from pre-TSST-A to 10, 20, 30, and 60 minutes post-TSST-A
Measured: Day 29
Physiological Stress Markers (Heart Rate) During Trier Social Stress Test - Arithmetic (TSST-A) - Multiple-Day Dosing
Change in heart rate (bpm) from pre-TSST-A to 60 minutes post-TSST-A.
Measured: Day 29
Awakening Cortisol Response
Change in morning awakening salivary cortisol over 30 minutes from baseline to Day 29.
Measured: Baseline Day 1 to Day 29
Awakening Alpha-Amylase Response
Change in morning awakening alpha-amylase over 30 minutes from baseline to Day 29
Measured: Baseline Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start7 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Botanic Tonics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Ramsey Atallah, Study director, Botanic Tonics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469527
- Sponsor's protocol ID
- B05-25-02-T0083
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of Feel Free® Classic Tonic on Self-Perceived Stress and Pharmacokinetic Profile in Healthy Adults
- ClinicalTrials.gov ID
- NCT07469527
- Acronym / sponsor ID
- B05-25-02-T0083
- Conditions
- Anxiety, Physiological Stress, Stress
- Keywords
- Stress Control, Anxiety, Relaxation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Botanic Tonics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 7 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboNo Active Product per bottle |
| Feel Free Classic Tonic Dose 1 | Experimental | Other: Kava and Kratom Herbal SupplementActive Product of 380 mg Kava root extract and 1480 mg of dried Kratom Leaf powder per bottle |
| Feel Free Classic Tonic Dose 2 (half strength) | Experimental | Other: Kava and Kratom Herbal SupplementActive Product of 190 mg Kava root extract and 740 mg of dried Kratom Leaf powder per bottle |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Other | Placebo |
| Kava and Kratom Herbal SupplementFeel Free Classic Tonic Dose 1 (TP1) | Other | Feel Free Classic Tonic Dose 1 |
| Kava and Kratom Herbal SupplementFeel Free Classic Tonic Dose 2 (TP2 - Half Strength) | Other | Feel Free Classic Tonic Dose 2 (half strength) |
Primary outcome
Change in Perceived Stress Scale-10 (PSS-10) Score
Time frame: Baseline (Day 1) to Day 29
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.
17 secondary outcomes
Change in State-Trait Anxiety Inventory - State (STAI-S) - Single Dose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Day 1 to Day 29
Physiological Stress Markers (Cortisol) - Single Dose
Time frame: Day 1
Physiological Stress Markers (Alpha-Amylase) - Single Dose
Time frame: Day 1
Physiological Stress Markers (Cortisol) During Trier Social Stress Test - Arithmetic (TSST-A) - Single Dose
Time frame: Day 1
Physiological Stress Markers (Alpha-Amylase) During Trier Social Stress Test - Arithmetic (TSST-A) - Single Dose
Time frame: Day 1
Physiological Stress Markers (Heart Rate) During Trier Social Stress Test - Arithmetic (TSST-A) - Single Dose
Time frame: Day 1
Physiological Stress Markers (Cortisol) - Multiple-Day Dose
Time frame: Day 29
Physiological Stress Markers (Alpha-Amylase) - Multiple-Day Dose
Time frame: Day 29
Physiological Stress Markers (Cortisol) During Trier Social Stress Test - Arithmetic (TSST-A) - Multiple-Day Dosing
Time frame: Day 29
Physiological Stress Markers (Alpha-Amylase) During Trier Social Stress Test - Arithmetic (TSST-A) - Multiple-Day Dosing
Time frame: Day 29
Physiological Stress Markers (Heart Rate) During Trier Social Stress Test - Arithmetic (TSST-A) - Multiple-Day Dosing
Time frame: Day 29
Awakening Cortisol Response
Time frame: Baseline Day 1 to Day 29
Awakening Alpha-Amylase Response
Time frame: Baseline Day 1 to Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramsey Atallah study director
Botanic Tonics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kava and Kratom Herbal Supplement in people with Anxiety and Physiological Stress, run by Botanic Tonics, LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ambreen Atif, MD (519-341-3367 ext. 129, aatif@nutrasource.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale-10 (PSS-10) Score (time frame: Baseline (Day 1) to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.