FatigueNCT02401776
Effect of Caffeine on Heart Function
A study testing Monster Energy Drink and Coffee in people with Fatigue and Tachycardia, run by University of Texas at Austin at 1 site in United States.
Trial summary
The primary objective of this study is to assess the effect of an energy drink on ventricular repolarization as measured by the interval between the cardiac Q wave and the cardiac T wave (QT interval)obtained from the body surface ECG. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Tachycardia
- What is being tested?
- Monster Energy Drink and Coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2015
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- BMI between 24 - 29
Who cannot join
- Resting heart rate below 60 bpm
- Resting heart rate above 88 bpm
- Cardiovascular or metabolic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Environmental and Autonomic Physiology Laboratory; University of Texas at Austin
Austin, Texas, 78721
About this study
Official title: An Evaluation of the Heart Rate, Blood Pressure and Repolarization Effects of an Energy Drink as Compared to Coffee
- The primary objective of this study is to assess the effect of an energy drink on ventricular repolarization as measured by the interval between the cardiac Q wave and the cardiac T wave (QT interval)obtained from the body surface ECG.
- The secondary objective is to assess the effects of an energy drink on heart rate and blood pressure (hemodynamic effects).
To place the observed changes in context, comparison will be made to a commonly consumed drink, coffee: Starbuck's K-cup Breakfast Blend.
Read the detailed description
This study will assess cardiac repolarization before and after three conditions each of which will involve the subject drinking beverages of varying caffeine content.
- Conditions
- Fatigue, Tachycardia
- Being tested
- Monster Energy Drink, Coffee
- Keywords
- heart rate, blood pressure, caffeine, energy drink
- Medical subject headings
- Fatigue, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monster Energy DrinkDietary supplement
Small Dose of Monster energy drink. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 16 ounce can of monster energy drink for a person weighing 75 kg).
Monster energy drinkDietary supplement
Medium Dose of Monster Energy Drink. This will be given at a dose of 3 mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).
Monster Energy DrinkDietary supplement
Monster energy drink. This will be given at a dose of 3mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).
CoffeeDietary supplement
Coffee. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 8 ounce cup of coffee drink for a person weighing 75 kg).
| Study group | Role | What they receive |
|---|---|---|
| small dose monster energy drink | Experimental | This will be a small dose of monster energy drink Receives: Dietary Supplement: Monster Energy Drink; Dietary Supplement: Coffee |
| medium dose monster energy drink | Experimental | This will be a medium dose of monster energy drink Receives: Dietary Supplement: Monster Energy Drink; Dietary Supplement: Coffee |
| coffee | Active comparator | This will be a coffee group and will drink Starbuck's K-cup Breakfast Blend. This will be mixed according to packing instructions and will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 11 ounce cup of coffee for a person weighing 75 kg). Receives: Dietary Supplement: Monster Energy Drink; Dietary Supplement: Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT interval will be measured in msec
The investigators will be measuring cardiac QT interval before (baseline) and for 5 hours post beverage consumption. The measurements will be made in msec.
Measured: 19 hrs
Secondary outcomes (2)
Heart rate will be measured as beats per minute.
The investigators will be measuring cardiac heart rate before (baseline) and for 5 hours post beverage consumption. The measurements will be made as beats per minute.
Measured: 19 hrs
Blood Pressure will be measured in the brachial artery as mmHG
The investigators will be measuring artery blood pressure before (baseline) and for 5 hours post beverage consumption. The measurements will be made as mmHg.
Measured: 19 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M. Brothers, University of Texas at Austin
- Investigators
- Robert M Brothers, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401776
- Sponsor's protocol ID
- 2014-03-0069
- Status last verified
- Oct 2016
- First submitted
- 20 May 2014
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Heart Rate, Blood Pressure and Repolarization Effects of an Energy Drink as Compared to Coffee
- ClinicalTrials.gov ID
- NCT02401776
- Acronym / sponsor ID
- 2014-03-0069
- Conditions
- Fatigue, Tachycardia
- Keywords
- heart rate, blood pressure, caffeine, energy drink
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Mar 2015 (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.
- The primary objective of this study is to assess the effect of an energy drink on ventricular repolarization as measured by the interval between the cardiac Q wave and the cardiac T wave (QT interval)obtained from the body surface ECG.
- The secondary objective is to assess the effects of an energy drink on heart rate and blood pressure (hemodynamic effects).
To place the observed changes in context, comparison will be made to a commonly consumed drink, coffee: Starbuck's K-cup Breakfast Blend.
Detailed description
This study will assess cardiac repolarization before and after three conditions each of which will involve the subject drinking beverages of varying caffeine content.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| small dose monster energy drink | Experimental | Dietary Supplement: Monster Energy Drink, Dietary Supplement: CoffeeThis will be a small dose of monster energy drink |
| medium dose monster energy drink | Experimental | Dietary Supplement: Monster Energy Drink, Dietary Supplement: CoffeeThis will be a medium dose of monster energy drink |
| coffee | Active comparator | Dietary Supplement: Monster Energy Drink, Dietary Supplement: CoffeeThis will be a coffee group and will drink Starbuck's K-cup Breakfast Blend. This will be mixed according to packing instructions and will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 11 ounce cup of coffee for a person weighing 75 kg). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- BMI between 24 - 29
Key exclusion criteria (3 listed)
- Resting heart rate below 60 bpm
- Resting heart rate above 88 bpm
- Cardiovascular or metabolic 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 |
|---|---|---|
| Monster Energy DrinkSmall Dose of Monster energy drink. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 16 ounce can of monster energy drink for a person weighing 75 kg). | Dietary supplement | coffee, medium dose monster energy drink, small dose monster energy drink |
| Monster energy drinkMedium Dose of Monster Energy Drink. This will be given at a dose of 3 mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg). | Dietary supplement | coffee, medium dose monster energy drink, small dose monster energy drink |
| Monster Energy DrinkMonster energy drink. This will be given at a dose of 3mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg). | Dietary supplement | coffee, medium dose monster energy drink, small dose monster energy drink |
| CoffeeCoffee. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 8 ounce cup of coffee drink for a person weighing 75 kg). | Dietary supplement | coffee, medium dose monster energy drink, small dose monster energy drink |
Primary outcome
QT interval will be measured in msec
Time frame: 19 hrs
The investigators will be measuring cardiac QT interval before (baseline) and for 5 hours post beverage consumption. The measurements will be made in msec.
2 secondary outcomes
Heart rate will be measured as beats per minute.
Time frame: 19 hrs
Blood Pressure will be measured in the brachial artery as mmHG
Time frame: 19 hrs
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 18 Oct 2016.
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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.
Robert M Brothers, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monster Energy Drink and Coffee in people with Fatigue and Tachycardia, run by University of Texas at Austin 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 2 inclusion and 3 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 18 Oct 2016. 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 interval will be measured in msec (time frame: 19 hrs). 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 18 Oct 2016.