Impact of Energy Drink Brands on Heart Rhythm
1 other identifier
interventional
40
1 country
1
Brief Summary
To assess the cardiac effects of energy drink brands in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2017
CompletedDecember 24, 2018
December 1, 2018
6 months
June 20, 2017
December 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Corrected QT (QTc) Interval
Electrocardiograph (ECG) Parameters
4 hours
Secondary Outcomes (6)
QT
4 hours
PR
4 hours
QRS
4 hours
Heart Rate (HR)
4 hours
Central blood pressure
4 hours
- +1 more secondary outcomes
Study Arms (3)
Energy Drink Brand 1
EXPERIMENTALTwo 16-oz bottles of Energy Drink Brand 1
Energy Drink Brand 2
EXPERIMENTALTwo 16-oz bottles of Energy Drink Brand 2
Placebo
PLACEBO COMPARATORTwo 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring
Interventions
Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes
Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of the Pacific
Stockton, California, 95211, United States
Related Publications (1)
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.
PMID: 31137991DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sachin Shah, PharmD
University of the Pacific
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 23, 2017
Study Start
July 1, 2017
Primary Completion
December 30, 2017
Study Completion
December 30, 2017
Last Updated
December 24, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share