Clinical trial NCT06949540: A Clinical Trial to Evaluate the Effects of a Herbal Tincture on Energy Levels, Weight Management, and Markers of Metabolic Health
Official title: A Clinical Trial to Evaluate the Effects of a Herbal Tincture on Energy Levels, Weight Management, and Markers of Metabolic Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress
Fatigue
Keywords: Weight Management
Energy Levels
Lead sponsor: Apothekary
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2025-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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:

  1. Self-reported feelings of stress.
  2. Self-reported issues with maintaining their current body weight or losing weight.
* 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.

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
measure: Change in cortisol levels
timeFrame: Baseline and Week 12
measure: Change in body mass
timeFrame: Baseline and Week 12
measure: Change in self-reported energy levels
timeFrame: Baseline, Week 2, Week 4, Week 8, and Week 12
Secondary outcomes:
measure: Change in perceived workout performance and health metrics
timeFrame: Baseline, Week 2, Week 4, Week 8, and Week 12
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Citruslabs
state: Nevada
Study officials:
References: