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Impact of Energy Drinks on Cardiovascular Endpoints

This study has been terminated.
(Unable to recruit enough subjects)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329679
First Posted: April 6, 2011
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sachin Shah, David Grant U.S. Air Force Medical Center
Results First Submitted: August 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition: Healthy Volunteers
Interventions: Dietary Supplement: 5 Hour Energy
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Energy Drink, Then Placebo No text entered.
Placebo, Then Energy Drink No text entered.

Participant Flow:   Overall Study
    Energy Drink, Then Placebo   Placebo, Then Energy Drink
STARTED   13   13 
COMPLETED   13   13 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants 5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      26 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Age   28.3  (5.77) 
Gender 
[Units: Participants]
Count of Participants
 
Female      6  23.1% 
Male      20  76.9% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   20 
African American   2 
Asian   2 
Hispanic   2 
Region of Enrollment 
[Units: Participants]
 
United States   26 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Office Systolic Blood Pressure   [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]

2.  Secondary:   Office DBP After a Single Energy Shot and After Chronic Consumption   [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]

3.  Secondary:   Max Heart Rate After a Single Shot and After Chronic Consumption   [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]

4.  Secondary:   Max PR-interval After a Single Shot and After Chronic Consumption   [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]

5.  Secondary:   Max QRS Duration After a Single Shot and After Chronic Consumption   [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]

6.  Secondary:   Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7   [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]

7.  Secondary:   Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7   [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size and limited to 7 days of consumption.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sachin Shah
Organization: DavidGrant
phone: 707-423-3277
e-mail: sshah@pacific.edu



Responsible Party: Sachin Shah, David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT01329679     History of Changes
Other Study ID Numbers: FWH20110111H
First Submitted: April 4, 2011
First Posted: April 6, 2011
Results First Submitted: August 29, 2016
Results First Posted: January 10, 2017
Last Update Posted: January 10, 2017