Impact of Energy Drinks on Cardiovascular Endpoints

Effects of Single and Multiple Energy Shots on Blood Pressure and Electrocardiographic Parameters: A Randomized, Double Blind, Crossover, Placebo-controlled Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01329679

Enrollment

Registered

2011-04-06

Start date

2011-04-30

Completion date

2013-07-31

Last updated

2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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

Interventions

DIETARY_SUPPLEMENTEnergy Drink

Energy drink, 2oz twice daily for 7 days

OTHERPlacebo

Water, lime juice and cherry flavoring

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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
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 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 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 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

Participant flow

Participants by arm

Arm	Count
All Study Participants Energy drink: Energy drink, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring	26
Total	26

Baseline characteristics

Characteristic	All Study Participants
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	26 Participants
Age, Continuous Age	28.3 years STANDARD_DEVIATION 5.77
Race/Ethnicity, Customized African American	2 participants
Race/Ethnicity, Customized Asian	2 participants
Race/Ethnicity, Customized Caucasian	20 participants
Race/Ethnicity, Customized Hispanic	2 participants
Region of Enrollment United States	26 participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 26	0 / 26
serious Total, serious adverse events	0 / 26	0 / 26

Outcome results

Primary

Change in Office Systolic Blood Pressure

SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.