Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-25 @ 4:52 PM
Study NCT ID:
NCT07212803
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Energy Drinks on Cardiovascular Endpoints
Sponsor:
University of the Pacific
Organization:
Study Overview
Official Title:
Evaluation of Energy Drinks on Electrocardiographic Parameters: A Randomized, Double Blind, Controlled, Crossover, Proof-of-concept Study
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical trial looking at the impact of energy drinks on heart related parameters. The study will enroll 3 participants who will be exposed to 8 different interventions.
Detailed Description:
This study is a randomized, double-blind, controlled, crossover, proof-of-concept trial designed to examine how energy drinks affect heart rhythm and other health measures in healthy adults aged 18 to 40. This study investigates the cardiovascular safety of energy drinks by examining their effects on electrocardiographic parameters, with a specific focus on the QTc interval.
The protocol consists of two phases conducted with 3 healthy volunteers. Phase A (Visits 1-4) evaluates four interventions: 1) energy drink A 2) moxifloxacin 3) caffeine 4) placebo.
Phase B (Visits 5-8) evaluates four interventions: 1) energy drink B 2) taurine 3) caffeine + taurine 4) lower dose energy drink A.
After an overnight fast participants will consume the study intervention within a 30 minute period. Over the next 4 hours, the electrocardiogram, blood pressure, hemodynamics, glucose, endothelial function, and side effects will be monitored. Participants maintain minimal physical activity during this period.
The protocol consists of two phases conducted with 3 healthy volunteers. Phase A (Visits 1-4) evaluates four interventions: 1) energy drink A 2) moxifloxacin 3) caffeine 4) placebo.
Phase B (Visits 5-8) evaluates four interventions: 1) energy drink B 2) taurine 3) caffeine + taurine 4) lower dose energy drink A.
After an overnight fast participants will consume the study intervention within a 30 minute period. Over the next 4 hours, the electrocardiogram, blood pressure, hemodynamics, glucose, endothelial function, and side effects will be monitored. Participants maintain minimal physical activity during this period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: