Impact of Energy Drinks on Cardiovascular Endpoints

Not Applicable

Terminated

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Energy Drink; Other: Placebo

• Registration Number: NCT01329679
• Lead Sponsor: David Grant U.S. Air Force Medical Center

Brief Summary

Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects.

Study design: Double blind, placebo controlled, cross-over

Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions.

Intervention: Energy drink or Placebo

Primary outcome: Change in office systolic blood pressure

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2016-08-29
• Results First Submitted QC: 2016-11-13
• Results First Posted: 2017-01-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Healthy volunteers between ages 18-40 years
• ONLY "as needed" use of ibuprofen or acetamenophen
• Active duty military
• DoD beneficiary or Civilian Government Employees

Exclusion Criteria

• No other co-morbid conditions
• No active prescription or OTC drug use
• Not pregnant or planning to become pregnant during study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Energy Drink	Energy Drink	Energy drink, 2 oz twice daily for 7 days
Placebo	Placebo	Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days

Primary Outcome Measures

Name	Time	Method
Change in Office Systolic Blood Pressure	At baseline and 7 days post energy drink and placebo consumption	SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.

Secondary Outcome Measures

Name	Time	Method
Office DBP After a Single Energy Shot and After Chronic Consumption	At baseline and 7 days post energy drink and placebo consumption	DBP = Diastolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.
Max Heart Rate After a Single Shot and After Chronic Consumption	At baseline and 7 days post energy drink and placebo consumption	Maximum heart rate measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7	At baseline and 7 days post energy drink and placebo consumption	Max QTc interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7	At baseline and 7 days post energy drink and placebo consumption	Max QT interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
Max QRS Duration After a Single Shot and After Chronic Consumption	At baseline and 7 days post energy drink and placebo consumption	Max QRS duration measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
Max PR-interval After a Single Shot and After Chronic Consumption	At baseline and 7 days post energy drink and placebo consumption	Maximum PR-interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days