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This is a clinical trial looking at the impact of energy drinks on heart related parameters. The study will enroll 3 participants who will be exposed to 8 different interventions.
This study is a randomized, double-blind, controlled, crossover, proof-of-concept trial designed to examine how energy drinks affect heart rhythm and other health measures in healthy adults aged 18 to 40. This study investigates the cardiovascular safety of energy drinks by examining their effects on electrocardiographic parameters, with a specific focus on the QTc interval.
The protocol consists of two phases conducted with 3 healthy volunteers. Phase A (Visits 1-4) evaluates four interventions: 1) energy drink A 2) moxifloxacin 3) caffeine 4) placebo.
Phase B (Visits 5-8) evaluates four interventions: 1) energy drink B 2) taurine 3) caffeine + taurine 4) lower dose energy drink A.
After an overnight fast participants will consume the study intervention within a 30 minute period. Over the next 4 hours, the electrocardiogram, blood pressure, hemodynamics, glucose, endothelial function, and side effects will be monitored. Participants maintain minimal physical activity during this period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase A: Energy Drink A + Placebo | Experimental | Energy Drink A (320 mg caffeine) consumed with placebo capsule |
|
| Phase A: Placebo Drink + Moxifloxacin | Active Comparator | Placebo drink with 400 mg moxifloxacin capsule |
|
| Phase A: Placebo Drink + Caffeine | Active Comparator | Placebo drink with 320 mg caffeine capsule |
|
| Phase A: Placebo Drink + Placebo Capsule | Placebo Comparator | Placebo drink with Placebo capsule |
|
| Phase B: Energy Drink B | Experimental | Energy Drink B (320 mg caffeine) |
|
| Phase B: Control + Taurine | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Drink A + Placebo Capsule | Dietary Supplement | 1000 mL caffeine- and taurine-containing commercially available beverage (Formula A) consumed with placebo capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Corrected QT Interval (QTc) in Milliseconds (ms) | QTc interval will be calculated using both Bazett's and Fridericia's correction formulas assessed via 12-lead ECG. | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in QT Interval in Milliseconds (ms) | As assessed via 12-lead ECG | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in RR Interval in Milliseconds (ms) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quy Phan, PharmD | Contact | 209-946-7754 | qphan@pacific.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Pacific | Recruiting | Stockton | California | 95211 | United States |
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Randomized, Double-Blind, Controlled, Crossover Study
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Control product with 4000 mg taurine powder
|
| Phase B: Control + Caffeine + Taurine | Experimental | Control product with 320 mg caffeine + 4000 mg taurine powder |
|
| Phase B: Lower Dose Energy Drink A | Experimental | Energy Drink A (189 mg caffeine) |
|
| Placebo Drink + Moxifloxacin Capsule | Drug | Placebo drink with 400 mg moxifloxacin capsule |
|
| Placebo Drink + Caffeine Capsule | Dietary Supplement | Placebo drink with 320 mg caffeine capsule |
|
| Placebo Drink + Placebo Capsule | Other | Placebo drink with placebo capsule |
|
| Energy Drink B | Dietary Supplement | 568 mL caffeine- and taurine-containing commercially available beverage (Formula B) |
|
| Control Product + Taurine | Dietary Supplement | Control product with 4000 mg taurine powder |
|
| Control Product + Caffeine + Taurine | Dietary Supplement | Control product with 320 mg caffeine + 4000 mg taurine powder |
|
| Lower Dose Energy Drink A | Dietary Supplement | 591 mL caffeine- and taurine-containing commercially available beverage (Formula A) |
|
As assessed via 12-lead ECG
| Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in PR Interval in Milliseconds (ms) | As assessed via 12-lead ECG | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in QRS Duration in Milliseconds (ms) | As assessed via 12-lead ECG | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in Systolic Blood Pressure (SBP) in Millimeters of Mercury (mmHg) | Assessed via a non-invasive automated blood pressure device | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in Diastolic Blood Pressure (DBP) in Millimeters of Mercury (mmHg) | Assessed via a non-invasive automated blood pressure device | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in Heart Rate (HR) in Beats Per Minute (BPM) | Assessed via non-invasive bioimpedance monitoring and/or 12-lead ECG | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in Cardiac Output (CO) in Liters Per Minute (L/min) | Assessed via non-invasive bioimpedance monitoring during Phase A only | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in Stroke Volume (SV) in Milliliters Per Beat (mL/beat) | Assessed via non-invasive bioimpedance monitoring during Phase A only | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in Interstitial Glucose Level (mg/dL) | Assessed via a continuously worn arm sensor (Continuous Glucose Monitor, CGM) during Phase A only | Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention |
| Change from Baseline in Reactive Hyperemia Index (RHI) | A non-invasive, unitless measure of endothelial function assessed via peripheral arterial tonometry (EndoPAT) during Phase A only | Baseline, 120, and 240 minutes post-intervention |
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D002110 | Caffeine |
| D035061 | Control Groups |
| D013654 | Taurine |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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