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Active, Not Recruiting

NCT Number: NCT06949540

A Clinical Trial to Evaluate the Effects of a Herbal Tincture on Energy Levels, Weight Management, and Markers of Metabolic Health

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Las Vegas, Nevada, 89118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Self-reported feelings of stress.
  • 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.

Treatment and study plan

Blue Burn Tincture

Dietary Supplement

Participants will complete self-assessments and provide weight and blood measurements during the study.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in perceived workout performance and health metrics

    Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12

    Questionnaires will assess participant perceptions of workout performance, stamina, exercise recovery, weight management, fitness, and overall health.

Sponsors and collaborators

Lead sponsor

Apothekary

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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