Electrical Alternation of HeartNCT03196908
Impact of Energy Drink Brands on Heart Rhythm
A study testing Energy Drink Brand 1 and Energy Drink Brand 2 in people with Electrical Alternation of Heart and Blood Pressure, run by University of the Pacific at 1 site in United States.
Trial summary
To assess the cardiac effects of energy drink brands in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrical Alternation of Heart, Blood Pressure
- What is being tested?
- Energy Drink Brand 1 and Energy Drink Brand 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Dec 2017
- 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 sessions on Day 1, 8, and 15
Who cannot join
- Presence of any known medical condition confirmed through participant interview
- QTc interval greater than 450 milliseconds (ms).
- Blood pressure greater than 140/90 mmHg.
- Current smokers
- Concurrent use of prescription, over-the-counter (OTC) or herbal supplements taken on a daily basis (except oral contraceptives).
- Pregnant or currently breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of the Pacific
Stockton, California, 95211
About this study
Official title: Impact of Energy Drink Brands on Heart Rhythm in Healthy Volunteers: A Randomized Controlled Trial
To assess the cardiac effects of energy drink brands in healthy volunteers
Read the detailed description
Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.
- Conditions
- Electrical Alternation of Heart, Blood Pressure
- Being tested
- Energy Drink Brand 1, Energy Drink Brand 2, Placebo
- Keywords
- ECG, Blood Pressure, Energy Drinks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Drink Brand 1Dietary supplement
Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes
Energy Drink Brand 2Dietary supplement
Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes
PlaceboOther
Lime juice, water, and cherry flavoring
| Study group | Role | What they receive |
|---|---|---|
| Energy Drink Brand 1 | Experimental | Two 16-oz bottles of Energy Drink Brand 1 Receives: Dietary Supplement: Energy Drink Brand 1 |
| Energy Drink Brand 2 | Experimental | Two 16-oz bottles of Energy Drink Brand 2 Receives: Dietary Supplement: Energy Drink Brand 2 |
| Placebo | Placebo comparator | Two 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected QT (QTc) Interval
Electrocardiograph (ECG) Parameters
Measured: 4 hours
Secondary outcomes (6)
QT
Electrocardiograph (ECG) Parameters
Measured: 4 hours
PR
Electrocardiograph (ECG)Parameters
Measured: 4 hours
QRS
Electrocardiograph (ECG) Parameters
Measured: 4 hours
Heart Rate (HR)
Electrocardiograph (ECG) Parameters
Measured: 4 hours
Central blood pressure
Hemodynamic Parameters
Measured: 4 hours
Peripheral blood pressure
Hemodynamic Parameters
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Jul 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
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 Electrical Alternation of HeartStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sachin Shah, PharmD, Principal investigator, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196908
- Sponsor's protocol ID
- 17-109
- Status last verified
- Dec 2018
- First submitted
- 20 Jun 2017
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah SA, Szeto AH, Farewell R, Shek A, Fan D, Quach KN, Bhattacharyya M, Elmiari J, Chan W, O'Dell K, Nguyen N, McGaughey TJ, Nasir JM, Kaul S. Impact of High Volume Energy Drink Consumption on Electrocardiographic and Blood Pressure Parameters: A Randomized Trial. J Am Heart Assoc. 2019 Jun 4;8(11):e011318. doi: 10.1161/JAHA.118.011318. Epub 2019 May 29.
PubMed 31137991
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Energy Drink Brands on Heart Rhythm in Healthy Volunteers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03196908
- Acronym / sponsor ID
- 17-109
- Conditions
- Electrical Alternation of Heart, Blood Pressure
- Keywords
- ECG, Blood Pressure, Energy Drinks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 23 Jun 2017 (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.
To assess the cardiac effects of energy drink brands in healthy volunteers
Detailed description
Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Energy Drink Brand 1 | Experimental | Dietary Supplement: Energy Drink Brand 1Two 16-oz bottles of Energy Drink Brand 1 |
| Energy Drink Brand 2 | Experimental | Dietary Supplement: Energy Drink Brand 2Two 16-oz bottles of Energy Drink Brand 2 |
| Placebo | Placebo comparator | Other: PlaceboTwo 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 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 sessions on Day 1, 8, and 15
Key exclusion criteria (6 listed)
- Presence of any known medical condition confirmed through participant interview
- QTc interval greater than 450 milliseconds (ms).
- Blood pressure greater than 140/90 mmHg.
- Current smokers
- Concurrent use of prescription, over-the-counter (OTC) or herbal supplements taken on a daily basis (except oral contraceptives).
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 Brand 1Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes | Dietary supplement | Energy Drink Brand 1 |
| Energy Drink Brand 2Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes | Dietary supplement | Energy Drink Brand 2 |
| PlaceboLime juice, water, and cherry flavoring | Other | Placebo |
Primary outcome
Corrected QT (QTc) Interval
Time frame: 4 hours
Electrocardiograph (ECG) Parameters
6 secondary outcomes
QT
Time frame: 4 hours
PR
Time frame: 4 hours
QRS
Time frame: 4 hours
Heart Rate (HR)
Time frame: 4 hours
Central blood pressure
Time frame: 4 hours
Peripheral blood pressure
Time frame: 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 24 Dec 2018.
- Derived from this study: PubMed 31137991Shah SA, Szeto AH, Farewell R, Shek A, Fan D, Quach KN, Bhattacharyya M, Elmiari J, Chan W, O'Dell K, Nguyen N, McGaughey TJ, Nasir JM, Kaul S. Impact of High Volume Energy Drink Consumption on Electrocardiographic and Blood Pressure Parameters: A Randomized Trial. J Am Heart Assoc. 2019 Jun 4;8(11):e011318. doi: 10.1161/JAHA.118.011318. Epub 2019 May 29.
- Individual participant dataSharing planned: No
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.
Sachin Shah, 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 Brand 1 and Energy Drink Brand 2 in people with Electrical Alternation of Heart and Blood Pressure, 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 2 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 24 Dec 2018. 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?
Corrected QT (QTc) Interval (time frame: 4 hours). 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 NCT03196908, 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 24 Dec 2018.