Healthy VolunteersPhase 4NCT07212803
Effects of Energy Drinks on Cardiovascular Endpoints
A Phase 4 study testing Energy Drink B in people with Healthy Volunteers and Safety After Oral Intake, run by University of the Pacific at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Safety After Oral Intake
- What is being tested?
- Energy Drink B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female adults 18-40 years of age
- Female participants of child-bearing potential must have a negative pregnancy test at the baseline visit
- 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: (1.) Consume up to 1 liter of fluid within a 30-minute period per visit (2.) 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)
- Participants must have active health insurance throughout the duration of the study
Who cannot join
- 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
- Presence of any known medical condition, confirmed through participant interview. Examples of these include but not limited to: Dyslipidemia, Thyroid disease, Diabetes, Recurrent headache, Any psychiatric condition or neurological disorder, History of alcohol or drug abuse, Past diagnosis or history of renal insufficiencies, Hepatic dysfunction, Electrolyte imbalances requiring hospitalization
- Presence of any known heart/cardiac diseases or conditions such as: Atrial Fibrillation, History of stroke or heart attack, Hypertension, Heart Failure, Vascular Disease, Family history/Active Long QT Syndrome, Coronary artery disease, Cardiomyopathy, Valvular heart disease, Ventricular arrhythmia, Congenital heart defect, Pericardial disease, Myocarditis
- Study physician recommendation for participant to not be enrolled.
- Are underweight (BMI<18.5 kg/m2, CDC 2024), have poor eating habits resulting in poor weight control, or have any factors that will put the participant at risk from fasting.
- Have any contraindications to the use of moxifloxacin, including a past medical history of myasthenia gravis, QT prolongation, or hypersensitivities and allergic reactions to moxifloxacin or any other fluoroquinolone antibiotics
Show all 19Show fewer
- Pre-existing risk to tendinitis and tendon rupture, peripheral neuropathy, or central nervous system side effects
- Concurrent use of ANY medication taken daily including herbal products or supplements (daily basis is defined as greater than 2 days per week)
- Self-reported allergy to taurine
- Self-reported allergy to nuts (peanuts, pecans, cashews, etc.)
- Self-reported allergic reaction to the adhesive pads (electrodes, continuous glucose monitors, etc.)
- Fear of needle puncture
- Smokers using cigarettes, vaporized nicotine, or marijuana products currently or within the past month
- Current usage of any nicotine or tobacco products including but not limited to intranasal, sublingual, oral, or transdermal dosage forms
- Currently pregnant or breastfeeding
- Have a positive pregnancy test during the baseline visit
- Are currently enrolled in any other clinical study or have participated in another study within the last 30 days
- Non-English speaking/reading individuals will be excluded due to the unavailability of medically qualified translators throughout all study procedures
- If the candidate does not sign the informed consent document
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of the Pacific
Stockton, California, 95211
Quy Phan, PharmD, 209-946-7754, pharmfip@pacific.edu
About this study
Official title: Evaluation of Energy Drinks on Electrocardiographic Parameters: A Randomized, Double Blind, Controlled, Crossover, Proof-of-concept Study
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers, Safety After Oral Intake
- Being tested
- Energy Drink A + Placebo Capsule, Placebo Drink + Moxifloxacin Capsule, Placebo Drink + Caffeine Capsule, Placebo Drink + Placebo Capsule, Energy Drink B
- Keywords
- Energy Drinks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Drink A + Placebo CapsuleDietary supplement
1000 mL caffeine- and taurine-containing commercially available beverage (Formula A) consumed with placebo capsule
Placebo Drink + Moxifloxacin CapsuleDrug
Placebo drink with 400 mg moxifloxacin capsule
Placebo Drink + Caffeine CapsuleDietary supplement
Placebo drink with 320 mg caffeine capsule
Placebo Drink + Placebo CapsuleOther
Placebo drink with placebo capsule
Energy Drink BDietary supplement
568 mL caffeine- and taurine-containing commercially available beverage (Formula B)
Control Product + TaurineDietary supplement
Control product with 4000 mg taurine powder
Control Product + Caffeine + TaurineDietary supplement
Control product with 320 mg caffeine + 4000 mg taurine powder
Lower Dose Energy Drink ADietary supplement
591 mL caffeine- and taurine-containing commercially available beverage (Formula A)
| Study group | Role | What they receive |
|---|---|---|
| Phase A: Energy Drink A + Placebo | Experimental | Energy Drink A (320 mg caffeine) consumed with placebo capsule Receives: Dietary Supplement: Energy Drink A + Placebo Capsule |
| Phase A: Placebo Drink + Moxifloxacin | Active comparator | Placebo drink with 400 mg moxifloxacin capsule Receives: Drug: Placebo Drink + Moxifloxacin Capsule |
| Phase A: Placebo Drink + Caffeine | Active comparator | Placebo drink with 320 mg caffeine capsule Receives: Dietary Supplement: Placebo Drink + Caffeine Capsule |
| Phase A: Placebo Drink + Placebo Capsule | Placebo comparator | Placebo drink with Placebo capsule Receives: Other: Placebo Drink + Placebo Capsule |
| Phase B: Energy Drink B | Experimental | Energy Drink B (320 mg caffeine) Receives: Dietary Supplement: Energy Drink B |
| Phase B: Control + Taurine | Experimental | Control product with 4000 mg taurine powder Receives: Dietary Supplement: Control Product + Taurine |
| Phase B: Control + Caffeine + Taurine | Experimental | Control product with 320 mg caffeine + 4000 mg taurine powder Receives: Dietary Supplement: Control Product + Caffeine + Taurine |
| Phase B: Lower Dose Energy Drink A | Experimental | Energy Drink A (189 mg caffeine) Receives: Dietary Supplement: Lower Dose Energy Drink A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Secondary outcomes (11)
Change from Baseline in QT Interval in Milliseconds (ms)
As assessed via 12-lead ECG
Measured: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in RR Interval in Milliseconds (ms)
As assessed via 12-lead ECG
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 120, and 240 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Nov 2025
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Double-Blind, Controlled, Crossover Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sachin Shah, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212803
- Sponsor's protocol ID
- IRB2025-207
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Energy Drinks on Electrocardiographic Parameters: A Randomized, Double Blind, Controlled, Crossover, Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT07212803
- Acronym / sponsor ID
- IRB2025-207
- Conditions
- Healthy Volunteers, Safety After Oral Intake
- Keywords
- Energy Drinks
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Randomized, Double-Blind, Controlled, Crossover Study
| Arm | Type | Receives |
|---|---|---|
| Phase A: Energy Drink A + Placebo | Experimental | Dietary Supplement: Energy Drink A + Placebo CapsuleEnergy Drink A (320 mg caffeine) consumed with placebo capsule |
| Phase A: Placebo Drink + Moxifloxacin | Active comparator | Drug: Placebo Drink + Moxifloxacin CapsulePlacebo drink with 400 mg moxifloxacin capsule |
| Phase A: Placebo Drink + Caffeine | Active comparator | Dietary Supplement: Placebo Drink + Caffeine CapsulePlacebo drink with 320 mg caffeine capsule |
| Phase A: Placebo Drink + Placebo Capsule | Placebo comparator | Other: Placebo Drink + Placebo CapsulePlacebo drink with Placebo capsule |
| Phase B: Energy Drink B | Experimental | Dietary Supplement: Energy Drink BEnergy Drink B (320 mg caffeine) |
| Phase B: Control + Taurine | Experimental | Dietary Supplement: Control Product + TaurineControl product with 4000 mg taurine powder |
| Phase B: Control + Caffeine + Taurine | Experimental | Dietary Supplement: Control Product + Caffeine + TaurineControl product with 320 mg caffeine + 4000 mg taurine powder |
| Phase B: Lower Dose Energy Drink A | Experimental | Dietary Supplement: Lower Dose Energy Drink AEnergy Drink A (189 mg caffeine) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female adults 18-40 years of age
- Female participants of child-bearing potential must have a negative pregnancy test at the baseline visit
- 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: (1.) Consume up to 1 liter of fluid within a 30-minute period per visit (2.) 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)
Key exclusion criteria (19 listed)
- 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
- Presence of any known medical condition, confirmed through participant interview. Examples of these include but not limited to: Dyslipidemia, Thyroid disease, Diabetes, Recurrent headache, Any psychiatric condition or neurological disorder, History of alcohol or drug abuse, Past diagnosis or history of renal insufficiencies, Hepatic dysfunction, Electrolyte imbalances requiring hospitalization
- Presence of any known heart/cardiac diseases or conditions such as: Atrial Fibrillation, History of stroke or heart attack, Hypertension, Heart Failure, Vascular Disease, Family history/Active Long QT Syndrome, Coronary artery disease, Cardiomyopathy, Valvular heart disease, Ventricular arrhythmia, Congenital heart defect, Pericardial disease, Myocarditis
- Study physician recommendation for participant to not be enrolled.
- Are underweight (BMI<18.5 kg/m2, CDC 2024), have poor eating habits resulting in poor weight control, or have any factors that will put the participant at risk from fasting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy Drink A + Placebo Capsule1000 mL caffeine- and taurine-containing commercially available beverage (Formula A) consumed with placebo capsule | Dietary supplement | Phase A: Energy Drink A + Placebo |
| Placebo Drink + Moxifloxacin CapsulePlacebo drink with 400 mg moxifloxacin capsule | Drug | Phase A: Placebo Drink + Moxifloxacin |
| Placebo Drink + Caffeine CapsulePlacebo drink with 320 mg caffeine capsule | Dietary supplement | Phase A: Placebo Drink + Caffeine |
| Placebo Drink + Placebo CapsulePlacebo drink with placebo capsule | Other | Phase A: Placebo Drink + Placebo Capsule |
| Energy Drink B568 mL caffeine- and taurine-containing commercially available beverage (Formula B) | Dietary supplement | Phase B: Energy Drink B |
| Control Product + TaurineControl product with 4000 mg taurine powder | Dietary supplement | Phase B: Control + Taurine |
| Control Product + Caffeine + TaurineControl product with 320 mg caffeine + 4000 mg taurine powder | Dietary supplement | Phase B: Control + Caffeine + Taurine |
| Lower Dose Energy Drink A591 mL caffeine- and taurine-containing commercially available beverage (Formula A) | Dietary supplement | Phase B: Lower Dose Energy Drink A |
Primary outcome
Change from Baseline in Corrected QT Interval (QTc) in Milliseconds (ms)
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
QTc interval will be calculated using both Bazett's and Fridericia's correction formulas assessed via 12-lead ECG.
11 secondary outcomes
Change from Baseline in QT Interval in Milliseconds (ms)
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in RR Interval in Milliseconds (ms)
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in PR Interval in Milliseconds (ms)
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in QRS Duration in Milliseconds (ms)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in Heart Rate (HR) in Beats Per Minute (BPM)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in Interstitial Glucose Level (mg/dL)
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in Reactive Hyperemia Index (RHI)
Time frame: Baseline, 120, and 240 minutes post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Energy Drink B in people with Healthy Volunteers and Safety After Oral Intake, run by University of the Pacific at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quy Phan, PharmD (209-946-7754, qphan@pacific.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Corrected QT Interval (QTc) in Milliseconds (ms) (time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.