Cardiovascular DiseasesNCT03841838
The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial
A study testing Energy drink in people with Cardiovascular Diseases, run by University of the Pacific at 1 site in United States.
Trial summary
Many adults in the United States regularly consumer energy drinks. Currently, the safety of energy drinks is still questionable and there are many reports associating energy drinks with adverse events including hospitalizations and deaths. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Energy drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2019to 9 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 old
- Participants must be willing to refrain from caffeine and alcohol use 48 hours prior to each study day
- Participants must be willing to fast 10 hours prior to each study day
- Participants must have health insurance
Who cannot join
- Corrected QT (QTc) interval greater than 450 milliseconds (ms). QTc will be determined on the ECG obtained during initial screening appointment.
- Blood pressure at initial screening appointment greater than 140/90 mmHg.
- Presence of any known medical condition confirmed through participant interview
- Concurrent use of ANY medication taken on a daily basis, to include herbal products or supplements (exception include oral contraceptives that will be allowed if taking for longer than 1 month)
- Current smokers or those who have smoked any cigarettes within the past month
- Pregnant or currently breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Many adults in the United States regularly consumer energy drinks. Currently, the safety of energy drinks is still questionable and there are many reports associating energy drinks with adverse events including hospitalizations and deaths. Previous research shows that energy drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher volume (32 ounces) of energy drinks than those available in the market (24 ounces). The purpose of this study is to study if 24-ounce energy drinks can significantly affect heart rhythm and elevate blood pressure when compared to a placebo.
Read the detailed description
The study is a randomized, double blind, controlled, crossover study comparing the effect of energy drinks and placebo on cardiovascular parameters including heart rhythm and blood pressure.
Subjects who contact the PI for interest in study participation will be scheduled a time to study facility for initial evaluation on eligibility criteria. At initial evaluation, participants will be informed about the study details, presented with Informed Consent Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to participate. Once consented, participants will be asked a series of questions and screened for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient is eligible to enroll, they will be allocated a randomized identification number.
Participants will be randomly assigned to consume either two-12 oz bottles of energy drink and two-12 oz bottles of control drink on 2 separate days. The study will occur over approximately 8 days with each session taking about 5 hours per day. Each session will have 6 days between each other.
Participants will be expected to refrain from any products containing caffeine or alcohol 48 hours and fast 10 hours before each study visit. At the beginning of each study visit, baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to consuming study drinks. Repeat measurements will be obtained every 60 minutes after consumption over 4 hours.
- Conditions
- Cardiovascular Diseases
- Being tested
- Energy drink, Placebo drink
- Keywords
- Energy drink, Heart rhythm, QT prolongation, Blood pressure
- Medical subject headings
- Cardiovascular Diseases, Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy drinkOther
Two 12 oz bottles of commercially available energy drink
Placebo drinkOther
Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring.
| Study group | Role | What they receive |
|---|---|---|
| Energy drink | Experimental | Two 12 oz bottles of energy drink Receives: Other: Energy drink |
| Placebo | Placebo comparator | Two 12 oz bottles of placebo drink Receives: Other: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc interval
Maximum change in QTc interval from baseline in each of 2 arm
Measured: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Central systolic blood pressure
Maximum change in central systolic blood pressure from baseline in each of 2 arm
Measured: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Secondary outcomes (7)
QT interval
Maximum change in QT interval from baseline in each of 2 arm
Measured: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
PR interval
Maximum change in PR interval from baseline in each of 2 arm
Measured: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
QRS duration
Maximum change in QRS duration from baseline in each of 2 arm
Measured: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Heart rate
Maximum change in heart rate from baseline in each of 2 arm
Measured: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Central diastolic blood pressure
Maximum change in central diastolic blood pressure from baseline in each of 2 arm
Measured: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Peripheral systolic and diastolic blood pressure
Maximum change in peripheral systolic and diastolic blood pressures in each of 2 arm
Measured: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Augmentation index
Maximum change in augmentation index from baseline in each of 2 arm
Measured: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start23 Feb 2019
- Primary completion9 May 2019
- Study completion9 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Lee, PharmD, Principal investigator, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841838
- Sponsor's protocol ID
- 19-03
- Status last verified
- Mar 2019
- First submitted
- 12 Feb 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fletcher EA, Lacey CS, Aaron M, Kolasa M, Occiano A, Shah SA. Randomized Controlled Trial of High-Volume Energy Drink Versus Caffeine Consumption on ECG and Hemodynamic Parameters. J Am Heart Assoc. 2017 Apr 26;6(5):e004448. doi: 10.1161/JAHA.116.004448.
PubMed 28446495Shah SA, Occiano A, Nguyen TA, Chan A, Sky JC, Bhattacharyya M, O'Dell KM, Shek A, Nguyen NN. Electrocardiographic and blood pressure effects of energy drinks and Panax ginseng in healthy volunteers: A randomized clinical trial. Int J Cardiol. 2016 Sep 1;218:318-323. doi: 10.1016/j.ijcard.2016.05.007. Epub 2016 May 13.
PubMed 27240158Shah SA, Chu BW, Lacey CS, Riddock IC, Lee M, Dargush AE. Impact of Acute Energy Drink Consumption on Blood Pressure Parameters: A Meta-analysis. Ann Pharmacother. 2016 Oct;50(10):808-15. doi: 10.1177/1060028016656433. Epub 2016 Jun 23.
PubMed 27340146Phan JK, Shah SA. Effect of caffeinated versus noncaffeinated energy drinks on central blood pressures. Pharmacotherapy. 2014 Jun;34(6):555-60. doi: 10.1002/phar.1419. Epub 2014 Mar 19.
PubMed 24644139Hajsadeghi S, Mohammadpour F, Manteghi MJ, Kordshakeri K, Tokazebani M, Rahmani E, Hassanzadeh M. Effects of energy drinks on blood pressure, heart rate, and electrocardiographic parameters: An experimental study on healthy young adults. Anatol J Cardiol. 2016 Feb;16(2):94-9. doi: 10.5152/akd.2015.5930. Epub 2015 Mar 23.
PubMed 26467367Elitok A, Oz F, Panc C, Sarikaya R, Sezikli S, Pala Y, Bugan OS, Ates M, Parildar H, Ayaz MB, Atici A, Oflaz H. Acute effects of Red Bull energy drink on ventricular repolarization in healthy young volunteers: a prospective study. Anatol J Cardiol. 2015 Nov;15(11):919-22. doi: 10.5152/akd.2015.5791. Epub 2015 Mar 5.
PubMed 25868042
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03841838
- Acronym / sponsor ID
- 19-03
- Conditions
- Cardiovascular Diseases
- Keywords
- Energy drink, Heart rhythm, QT prolongation, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 23 Feb 2019 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 15 Feb 2019 (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.
Many adults in the United States regularly consumer energy drinks. Currently, the safety of energy drinks is still questionable and there are many reports associating energy drinks with adverse events including hospitalizations and deaths. Previous research shows that energy drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher volume (32 ounces) of energy drinks than those available in the market (24 ounces). The purpose of this study is to study if 24-ounce energy drinks can significantly affect heart rhythm and elevate blood pressure when compared to a placebo.
Detailed description
The study is a randomized, double blind, controlled, crossover study comparing the effect of energy drinks and placebo on cardiovascular parameters including heart rhythm and blood pressure.
Subjects who contact the PI for interest in study participation will be scheduled a time to study facility for initial evaluation on eligibility criteria. At initial evaluation, participants will be informed about the study details, presented with Informed Consent Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to participate. Once consented, participants will be asked a series of questions and screened for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient is eligible to enroll, they will be allocated a randomized identification number.
Participants will be randomly assigned to consume either two-12 oz bottles of energy drink and two-12 oz bottles of control drink on 2 separate days. The study will occur over approximately 8 days with each session taking about 5 hours per day. Each session will have 6 days between each other.
Participants will be expected to refrain from any products containing caffeine or alcohol 48 hours and fast 10 hours before each study visit. At the beginning of each study visit, baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to consuming study drinks. Repeat measurements will be obtained every 60 minutes after consumption over 4 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy drink | Experimental | Other: Energy drinkTwo 12 oz bottles of energy drink |
| Placebo | Placebo comparator | Other: Placebo drinkTwo 12 oz bottles of placebo drink |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female adults 18-40 years old
- Participants must be willing to refrain from caffeine and alcohol use 48 hours prior to each study day
- Participants must be willing to fast 10 hours prior to each study day
- Participants must have health insurance
Key exclusion criteria (6 listed)
- Corrected QT (QTc) interval greater than 450 milliseconds (ms). QTc will be determined on the ECG obtained during initial screening appointment.
- Blood pressure at initial screening appointment greater than 140/90 mmHg.
- Presence of any known medical condition confirmed through participant interview
- Concurrent use of ANY medication taken on a daily basis, to include herbal products or supplements (exception include oral contraceptives that will be allowed if taking for longer than 1 month)
- Current smokers or those who have smoked any cigarettes within the past month
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 drinkTwo 12 oz bottles of commercially available energy drink | Other | Energy drink |
| Placebo drinkTwo 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring. | Other | Placebo |
Primary outcome
QTc interval
Time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Maximum change in QTc interval from baseline in each of 2 arm
Central systolic blood pressure
Time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Maximum change in central systolic blood pressure from baseline in each of 2 arm
7 secondary outcomes
QT interval
Time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
PR interval
Time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
QRS duration
Time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Heart rate
Time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Central diastolic blood pressure
Time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Peripheral systolic and diastolic blood pressure
Time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Augmentation index
Time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 28446495Fletcher EA, Lacey CS, Aaron M, Kolasa M, Occiano A, Shah SA. Randomized Controlled Trial of High-Volume Energy Drink Versus Caffeine Consumption on ECG and Hemodynamic Parameters. J Am Heart Assoc. 2017 Apr 26;6(5):e004448. doi: 10.1161/JAHA.116.004448.
- Background: PubMed 27240158Shah SA, Occiano A, Nguyen TA, Chan A, Sky JC, Bhattacharyya M, O'Dell KM, Shek A, Nguyen NN. Electrocardiographic and blood pressure effects of energy drinks and Panax ginseng in healthy volunteers: A randomized clinical trial. Int J Cardiol. 2016 Sep 1;218:318-323. doi: 10.1016/j.ijcard.2016.05.007. Epub 2016 May 13.
- Background: PubMed 27340146Shah SA, Chu BW, Lacey CS, Riddock IC, Lee M, Dargush AE. Impact of Acute Energy Drink Consumption on Blood Pressure Parameters: A Meta-analysis. Ann Pharmacother. 2016 Oct;50(10):808-15. doi: 10.1177/1060028016656433. Epub 2016 Jun 23.
- Background: PubMed 24644139Phan JK, Shah SA. Effect of caffeinated versus noncaffeinated energy drinks on central blood pressures. Pharmacotherapy. 2014 Jun;34(6):555-60. doi: 10.1002/phar.1419. Epub 2014 Mar 19.
- Background: PubMed 26467367Hajsadeghi S, Mohammadpour F, Manteghi MJ, Kordshakeri K, Tokazebani M, Rahmani E, Hassanzadeh M. Effects of energy drinks on blood pressure, heart rate, and electrocardiographic parameters: An experimental study on healthy young adults. Anatol J Cardiol. 2016 Feb;16(2):94-9. doi: 10.5152/akd.2015.5930. Epub 2015 Mar 23.
- Background: PubMed 25868042Elitok A, Oz F, Panc C, Sarikaya R, Sezikli S, Pala Y, Bugan OS, Ates M, Parildar H, Ayaz MB, Atici A, Oflaz H. Acute effects of Red Bull energy drink on ventricular repolarization in healthy young volunteers: a prospective study. Anatol J Cardiol. 2015 Nov;15(11):919-22. doi: 10.5152/akd.2015.5791. Epub 2015 Mar 5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Cynthia Lee, PharmD principal investigator
University of the Pacific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy drink in people with Cardiovascular Diseases, 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 25 Sep 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QTc interval (time frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03841838, which also lists 6 linked publications.
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 25 Sep 2019.