StressNCT06949540
A Clinical Trial to Evaluate the Effects of a Herbal Tincture on Energy Levels, Weight Management, and Markers of Metabolic Health
A study testing Blue Burn Tincture in people with Stress and Fatigue, run by Apothekary at 1 site in United States.
Trial summary
This study will evaluate the effects of the Blue Burn Tincture on energy levels, weight management, and markers of metabolic health. It is a single-arm, hybrid trial involving 40 participants over a 12-week period. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- What is being tested?
- Blue Burn Tincture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2025to 7 May 2025
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be male or female.
- Be aged 30 or over.
- Anyone who owns a body weight scale.
- Anyone currently experiencing issues regarding all of the following:
- Self-reported feelings of stress.
- Self-reported issues with maintaining their current body weight or losing weight.
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- Exercises at least once per week.
- If taking prescription medications, are willing to discuss this study with their physician before starting the study.
- Willing to maintain the study protocol for the study duration.
- Willing to refrain from taking any products, new medication, or supplements that target cortisol levels, stress, energy levels, or weight management during the study duration.
- If taking oral over-the-counter supplements or herbal remedies targeted at improving cortisol levels, stress, energy levels, or weight management, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.
- Willing to maintain their current diet, sleep schedule, and activity level for the study duration.
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- Resides in the United States.
- Not currently partaking in another research study and will not be partaking in any other research study for the next 12 weeks and at any point during this study's duration.
Who cannot join
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone who is planning to undergo any surgeries or invasive treatments for the study duration.
- Anyone diagnosed with a condition related to the thyroid.
- Anyone diagnosed with Type I or Type II diabetes.
- Anyone who has had any major illness in the last three months.
- Anyone who drinks heavily (i.e., eight or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
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- Anyone with an allergy to nightshade vegetables.
- Anyone with known severe allergic reactions to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone with a history of substance abuse.
- Anyone who is currently a smoker or has been a smoker in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the effects of the Blue Burn Tincture on energy levels, weight management, and markers of metabolic health. It is a single-arm, hybrid trial involving 40 participants over a 12-week period. Participants will use the product daily, complete scheduled questionnaires, attend blood tests at Labcorp (Baseline and Week 12), and provide body mass measurements. Primary outcomes include changes in cortisol levels, energy levels, and body mass.
- Being tested
- Blue Burn Tincture
- Keywords
- Weight Management, Energy Levels
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue Burn TinctureDietary supplement
Participants will complete self-assessments and provide weight and blood measurements during the study.
| Study group | Role | What they receive |
|---|---|---|
| Blue Burn Tincture Group | Experimental | Participants will receive 4 mL of the Blue Burn Tincture daily for 12 weeks. The dose is split into 2 mL in the morning and 2 mL at lunchtime (before 2 PM), mixed with water or another liquid. Receives: Dietary Supplement: Blue Burn Tincture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cortisol levels
Measured via morning blood draws at Baseline and Week 12 to assess the physiological impact of the tincture on stress hormone regulation.
Measured: Baseline and Week 12
Change in body mass
Self-reported daily body mass measurements for 3 days at Baseline and Week 12; mean values will be calculated to determine any weight changes.
Measured: Baseline and Week 12
Change in self-reported energy levels
Participants will complete validated questionnaires evaluating energy at multiple time points to assess perceived improvements in fatigue and vitality.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
Secondary outcomes (1)
Change in perceived workout performance and health metrics
Questionnaires will assess participant perceptions of workout performance, stamina, exercise recovery, weight management, fitness, and overall health.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start7 Feb 2025
- Primary completion7 May 2025 (estimated)
- Study completion7 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apothekary
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949540
- Sponsor's protocol ID
- 20716
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effects of a Herbal Tincture on Energy Levels, Weight Management, and Markers of Metabolic Health
- ClinicalTrials.gov ID
- NCT06949540
- Acronym / sponsor ID
- 20716
- Keywords
- Weight Management, Energy Levels
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ApothekaryIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 7 May 2025 (estimated)
- Study completion
- 7 May 2025 (estimated)
- First posted
- 29 Apr 2025 (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 will evaluate the effects of the Blue Burn Tincture on energy levels, weight management, and markers of metabolic health. It is a single-arm, hybrid trial involving 40 participants over a 12-week period. Participants will use the product daily, complete scheduled questionnaires, attend blood tests at Labcorp (Baseline and Week 12), and provide body mass measurements. Primary outcomes include changes in cortisol levels, energy levels, and body mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blue Burn Tincture Group | Experimental | Dietary Supplement: Blue Burn TinctureParticipants will receive 4 mL of the Blue Burn Tincture daily for 12 weeks. The dose is split into 2 mL in the morning and 2 mL at lunchtime (before 2 PM), mixed with water or another liquid. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Be male or female.
- Be aged 30 or over.
- Anyone who owns a body weight scale.
- Anyone currently experiencing issues regarding all of the following:
- Exercises at least once per week.
Key exclusion criteria (11 listed)
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone who is planning to undergo any surgeries or invasive treatments for the study duration.
- Anyone diagnosed with a condition related to the thyroid.
- Anyone diagnosed with Type I or Type II diabetes.
- Anyone who has had any major illness in the last three months.
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 |
|---|---|---|
| Blue Burn TinctureParticipants will complete self-assessments and provide weight and blood measurements during the study. | Dietary supplement | Blue Burn Tincture Group |
Primary outcome
Change in cortisol levels
Time frame: Baseline and Week 12
Measured via morning blood draws at Baseline and Week 12 to assess the physiological impact of the tincture on stress hormone regulation.
Change in body mass
Time frame: Baseline and Week 12
Self-reported daily body mass measurements for 3 days at Baseline and Week 12; mean values will be calculated to determine any weight changes.
Change in self-reported energy levels
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Participants will complete validated questionnaires evaluating energy at multiple time points to assess perceived improvements in fatigue and vitality.
1 secondary outcome
Change in perceived workout performance and health metrics
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
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 29 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue Burn Tincture in people with Stress and Fatigue, run by Apothekary at 1 site in United States.
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 15 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. 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 United States. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cortisol levels (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. 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 29 Apr 2025.