Hemodynamic Effects of Energy DrinkNCT02023723
Evaluation of Energy Drink Consumption on ECG and Hemodynamic Parameters in Young Healthy Volunteers
A study testing Energy Drink in people with Hemodynamic Effects of Energy Drink and Electrocardiograph Effects of Energy Drinks, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial summary
This study is designed as a safety assessment to determine the cardiac and hemodynamic effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and blood pressure measurements. It will evaluate the use of a consumer available product that is classified as a dietary supplement by the FDA. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Effects of Energy Drink, Electrocardiograph Effects of Energy Drinks
- What is being tested?
- Energy Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Oct 2014
- 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 and female, active duty military service members or DoD beneficiaries, who are eligible to receive care at DGMC.
- Ages 18-40 years old
- Participants must be willing to refrain from caffeine and energy drink use 48 hours prior to study days 1 and 8. They must also refrain from consuming additional caffeine or energy drinks during the 24-hour observation time on days 1-2 and 8-9.
Who cannot join
- Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, atherosclerosis, hypertension, palpitations, T-wave abnormalities, baseline corrected QT (QTc) interval greater than 440 milliseconds(ms). This will be determined on the ECG obtained during initial screening appointment, and reviewed by cardiologist and through the questionnaire responses of the participant.
- Blood pressure at initial screening appointment or at baseline on study Day 1 greater than 140/90
- Presence of any known medical condition, confirmed through participant interview. Examples of these are:
- Hypertension
- Thyroid disease
- Type 1 or 2 diabetes mellitus
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- Recurrent headaches
- Depression, currently receiving treatment (due to possible drug interactions)
- Any psychiatric condition or neurological disorder
- History of alcohol or drug abuse in the previous 5 years
- Ever been diagnosed or told they have or had renal or hepatic dysfunction
- Concurrent use of ANY medication taken on a daily basis, to include herbal products or supplements. Daily basis is defined as greater than 2 days per week.
- Pregnant or lactating females will be excluded from participation with urine dipstick tests used to confirm pregnancy (pregnancy test performed before each treatment session, days 1 and 8)
- All non-English speaking / writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
- If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant AF Medical Center
Travis Air Force Base, California, 94535
About this study
This study is designed as a safety assessment to determine the cardiac and hemodynamic effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and blood pressure measurements. It will evaluate the use of a consumer available product that is classified as a dietary supplement by the FDA.
- Being tested
- Energy Drink, Active Control
- Keywords
- Energy Drink, Electrocardiograph, Hemodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy DrinkDietary supplement
16oz energy drinks - 2 consumed within 60 minutes
Active ControlDietary supplement
16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Energy Drink | Experimental | 16oz original flavor energy drink consume 2 -16oz energy drinks within 60 minutes Receives: Dietary Supplement: Energy Drink; Dietary Supplement: Active Control |
| Active Control | Active comparator | 16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes Receives: Dietary Supplement: Energy Drink; Dietary Supplement: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT/QTc measured on an office ECG
Measured: 6 hours over 5 visits
Secondary outcomes (3)
Peripheral Blood pressure
systolic and diastolic
Measured: 6 hours with 5 visits
Central blood pressure
utilizing an applanation tonometry device
Measured: 6 hours over 5 visits
Augmentation Index, pulse wave
Measured: 6 hours over 5 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic Effects of Energy DrinkStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Emily Fletcher, PhamD, Principal investigator, David Grant AF Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023723
- Sponsor's protocol ID
- FDG20130042H
- Status last verified
- Apr 2020
- First submitted
- 24 Dec 2013
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 28446495
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Energy Drink Consumption on ECG and Hemodynamic Parameters in Young Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02023723
- Acronym / sponsor ID
- FDG20130042H
- Keywords
- Energy Drink, Electrocardiograph, Hemodynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Dec 2013 (estimated)
- 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 study is designed as a safety assessment to determine the cardiac and hemodynamic effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and blood pressure measurements. It will evaluate the use of a consumer available product that is classified as a dietary supplement by the FDA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy Drink | Experimental | Dietary Supplement: Energy Drink, Dietary Supplement: Active Control16oz original flavor energy drink consume 2 -16oz energy drinks within 60 minutes |
| Active Control | Active comparator | Dietary Supplement: Energy Drink, Dietary Supplement: Active Control16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female, active duty military service members or DoD beneficiaries, who are eligible to receive care at DGMC.
- Ages 18-40 years old
- Participants must be willing to refrain from caffeine and energy drink use 48 hours prior to study days 1 and 8. They must also refrain from consuming additional caffeine or energy drinks during the 24-hour observation time on days 1-2 and 8-9.
Key exclusion criteria (15 listed)
- Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, atherosclerosis, hypertension, palpitations, T-wave abnormalities, baseline corrected QT (QTc) interval greater than 440 milliseconds(ms). This will be determined on the ECG obtained during initial screening appointment, and reviewed by cardiologist and through the questionnaire responses of the participant.
- Blood pressure at initial screening appointment or at baseline on study Day 1 greater than 140/90
- Presence of any known medical condition, confirmed through participant interview. Examples of these are:
- Hypertension
- Thyroid disease
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 Drink16oz energy drinks - 2 consumed within 60 minutes | Dietary supplement | Active Control, Energy Drink |
| Active Control16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes | Dietary supplement | Active Control, Energy Drink |
Primary outcome
QT/QTc measured on an office ECG
Time frame: 6 hours over 5 visits
3 secondary outcomes
Peripheral Blood pressure
Time frame: 6 hours with 5 visits
Central blood pressure
Time frame: 6 hours over 5 visits
Augmentation Index, pulse wave
Time frame: 6 hours over 5 visits
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 22 Apr 2020.
- Derived from this study: 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.
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.
Emily Fletcher, PhamD principal investigator
David Grant AF Medical Center
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 Hemodynamic Effects of Energy Drink and Electrocardiograph Effects of Energy Drinks, run by David Grant U.S. Air Force Medical Center 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 3 inclusion and 15 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 22 Apr 2020. 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. 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?
QT/QTc measured on an office ECG (time frame: 6 hours over 5 visits). 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 NCT02023723, which also lists 1 linked publication.
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 22 Apr 2020.