Energy Drinks for Cardiovascular Health

Overseen By Quy Phan, PharmD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of the Pacific

Must not be taking: Daily medications

Disqualifiers: Heart disease, Diabetes, Psychiatric condition, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different energy drinks and ingredients affect heart health. Participants will try various combinations, including two specific energy drinks, Energy Drink A and Energy Drink B, and a placebo (a treatment with no active ingredients), to assess their impact on heart-related measures. The trial seeks healthy individuals who are willing to fast and can consume large amounts of liquid quickly. Participants should not have heart conditions or allergies to ingredients like taurine or nuts. As a Phase 4 trial, this research involves FDA-approved treatments and aims to understand how they can benefit more patients.

Do I need to stop taking my current medications to join the trial?

Yes, you must stop taking any medications, including herbal products or supplements, that you take daily (more than 2 days per week) to participate in this trial.

What is the safety track record for these treatments?

Research shows that energy drinks can affect the heart in various ways. For Energy Drink A, studies have found that these drinks might raise blood pressure and cause heart rhythm problems, especially in individuals with heart issues, due to their high caffeine content. Some reports also suggest that energy drinks can lead to irregular heartbeats.

Similarly, Energy Drink B, which also contains high caffeine levels, has been linked to serious heart problems, including heart attacks and cardiac arrest. In some cases, deaths have been related to energy drink use. These effects highlight the importance of caution, particularly for those with existing heart problems. While energy drinks are popular, they can pose risks to heart health. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the potential of energy drinks for cardiovascular health because they offer a unique combination of caffeine and taurine, which are not typical in standard heart health treatments. While most cardiovascular treatments focus on managing blood pressure, cholesterol, or heart rate through medications, these energy drinks provide an innovative approach by potentially improving heart function through increased alertness and energy. Energy Drink A and B both deliver significant caffeine dosages, with Energy Drink A being tested at a lower dose as well, which could offer varied effects on cardiovascular performance. Additionally, the inclusion of taurine in some treatment arms introduces a novel element that might enhance cardiovascular benefits, offering a new perspective on heart health management.

What evidence suggests that this trial's treatments could be effective for cardiovascular health?

This trial will compare the effects of Energy Drink A and Energy Drink B on cardiovascular health. Studies have shown that energy drinks can affect the heart. Research indicates that Energy Drink A can raise blood pressure and alter heart rhythms due to its caffeine content, making the heart work harder. Energy Drink B has similar effects, as studies also link it to increased blood pressure. Both drinks have been associated with changes in the heart, such as irregular heartbeats and higher blood pressure. Overall, evidence suggests that these energy drinks can impact heart health, but more research is needed to fully understand their long-term effects. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in the effects of energy drinks on heart health. Specific eligibility criteria are not provided, but typically participants should have no known cardiovascular issues and be within a certain age range.

Inclusion Criteria

Participants must be willing to refrain from caffeine and alcohol use 72 hours prior to sessions on study days

Participants must be willing and able to swallow a single large capsule per visit

Participants must be willing to fast 10 hours prior to sessions on study days (only water is allowed during the fasting and active study period)

Exclusion Criteria

Currently pregnant or breastfeeding

Have a corrected QT (QTc) interval greater than 450 milliseconds (ms) for males or greater than 470 milliseconds (ms) for females, determined during the baseline visit

Study physician recommendation for participant to not be enrolled

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase A

Participants undergo four interventions: energy drink A, moxifloxacin, caffeine, and placebo. Monitoring includes ECG, blood pressure, and other health measures.

4 visits

4 visits (in-person)

Phase B

Participants undergo four interventions: energy drink B, taurine, caffeine + taurine, and lower dose energy drink A. Monitoring includes ECG, blood pressure, and other health measures.

4 visits

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Energy Drink A
• Energy Drink B

Trial Overview The study tests how different products like energy drinks, caffeine capsules, and control substances with taurine affect cardiovascular endpoints. Participants will try 8 variations including placebos to compare their impacts.

How Is the Trial Designed?

Group I: Phase B: Lower Dose Energy Drink A Experimental Treatment 1 Intervention

Energy Drink A (189 mg caffeine)

Group II: Phase B: Energy Drink B Experimental Treatment 1 Intervention

Energy Drink B (320 mg caffeine)

Group III: Phase B: Control + Taurine Experimental Treatment 1 Intervention

Control product with 4000 mg taurine powder

Group IV: Phase B: Control + Caffeine + Taurine Experimental Treatment 1 Intervention

Control product with 320 mg caffeine + 4000 mg taurine powder

Group V: Phase A: Energy Drink A + Placebo Experimental Treatment 1 Intervention

Energy Drink A (320 mg caffeine) consumed with placebo capsule

Group VI: Phase A: Placebo Drink + Moxifloxacin Active Control 1 Intervention

Placebo drink with 400 mg moxifloxacin capsule

Group VII: Phase A: Placebo Drink + Caffeine Active Control 1 Intervention

Placebo drink with 320 mg caffeine capsule

Group VIII: Phase A: Placebo Drink + Placebo Capsule Placebo Group 1 Intervention

Placebo drink with Placebo capsule

Who Is Running the Clinical Trial?

University of the Pacific

Lead Sponsor

Trials

16

Recruited

1,000+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/jaha.118.011318

Impact of High Volume Energy Drink Consumption on ... We aim to determine the impact of energy drinks on electrocardiographic and hemodynamic parameters in young healthy volunteers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5714807/

Effects of energy drinks on the cardiovascular system - PMC Results showed that the fifteen minute systolic BP readings were significantly higher in the three energy drink trials (163.87, 166.47, and 165.00) compared to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05559372?term=PANAX%20GINSENG%20WHOLE&viewType=Table&rank=10

Energy Drink Effects on Performance, Mood, and ... Unfortunately, there are few studies that have (1) examined the effects of energy drink consumption on performance and cardiovascular safety, nor (2) compared ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352007823003153

Energy drink consumption can induce cardiovascular ... Studies have consistently found that ED consumption is associated with increased blood pressure, platelet aggregation, and arrhythmias.

5. link.springer.com link.springer.com/article/10.1007/s10654-025-01292-z

Chronic high consumption of energy drinks and ... So far there are no data on possible cardiovascular health effects of chronic high ED consumption. Only the EDUCATE-study and Mansour et al ...

6. mayoclinic.org mayoclinic.org/medical-professionals/cardiovascular-diseases/news/energy-drinks-may-trigger-cardiac-arrhythmias-in-patients-with-genetic-heart-disease/mac-20570446

Energy drinks may trigger cardiac arrhythmias in patients ... Patients prone to cardiac arrhythmias due to genetic heart disease could be at a higher risk of arrhythmia when consuming energy drinks.

7. thecardiologyadvisor.com thecardiologyadvisor.com/features/cardiovascular-effects-of-pre-workout-caffeine-and-energy-supplements/

Cardiovascular Effects of Pre-Workout Caffeine and Energy ... A range of cardiovascular side effects linked to consumption of energy drinks, including coronary disease, heart failure, cardiac arrhythmias, ventricular ...