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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue Burn Tincture | Dietary Supplement | Participants will complete self-assessments and provide weight and blood measurements during the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, Week 2, Week 4, Week 8, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 2, Week 4, Week 8, and Week 12 |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Las Vegas | Nevada | 89118 | United States |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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