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Stimulant
The Effect of Energy Drink Ingredients on Cardiovascular Function in Men and Women 18-39 Years Old (EEDICF Trial)
N/A
Waitlist Available
Research Sponsored by Duquesne University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 1, 2, 4, hours post-dose
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the hypothesis that the ingredients in energy drinks interact to cause increased systolic blood pressure and heart rate. The study will also test whether energy drinks cause changes in electrical activity of the heart that can be measured by an ECG. The study will enroll 300 participants who will be randomly assigned to one of four study groups. The first group will consume two cans of an energy drink per day for 3 days. The second group will consume two cans of an energy drink per day for 3 days along with a daily supplement of taurine. The third group will consume two cans of an energy drink per day for 3 days along with a
Eligible Conditions
- High Blood Pressure
- Arrhythmia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 1, 2, 4, hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 1, 2, 4, hours post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in QTc interval of EKG
Secondary study objectives
Change in Heart Rate
Change in Systolic and Diastolic Blood Pressure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Changes in BP, HR and EKG with Test Solution C and ExerciseExperimental Treatment1 Intervention
1. Subject baseline HR, BP, ECG recorded.
2. Subject will ingest sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg)
3. 30 min later, subject will exercise on a treadmill
Group II: Changes in BP, HR and EKG with Test Solution CExperimental Treatment1 Intervention
1. Subject baseline HR, BP, ECG recorded.
2. Subject will ingest sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg)
Group III: Changes in BP, HR and EKG with Test Solution B and ExerciseExperimental Treatment1 Intervention
1. Subject baseline HR, BP, ECG recorded.
2. Subject will ingest sucrose (150g); caffeine (400 mg)
3. 30 min later, subject will exercise on a treadmill
4. Subjects will return each week to repeat the above procedures with a different test solution.
Group IV: Changes in BP, HR and EKG with Test Solution A and ExerciseExperimental Treatment1 Intervention
1. Subject baseline HR, BP, EKG recorded.
2. Subject will ingest sucrose (150g):
3. 30 min later, subject will exercise on a treadmill
4. Subjects will return each week to repeat the above procedures with a different test solution.
Find a Location
Who is running the clinical trial?
Duquesne UniversityLead Sponsor
31 Previous Clinical Trials
2,449 Total Patients Enrolled
David Delmonico, Ph.D.Study ChairInstitutional Review Board, Chair, Duquesne University