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Clinical Trials/NCT01329679
NCT01329679TerminatedNot Applicable

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

David Grant U.S. Air Force Medical Center0 sites26 target enrollmentStarted: April 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
26
Primary Endpoint
Change in Office Systolic Blood Pressure
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Change in Office Systolic Blood Pressure

Time Frame: 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 Outcomes

  • Office DBP After a Single Energy Shot and After Chronic Consumption(At baseline and 7 days post energy drink and placebo consumption)
  • Max Heart Rate After a Single Shot and After Chronic Consumption(At baseline and 7 days post energy drink and placebo consumption)
  • 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 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 QRS Duration After a Single Shot and After Chronic Consumption(At baseline and 7 days post energy drink and placebo consumption)
  • Max PR-interval After a Single Shot and After Chronic Consumption(At baseline and 7 days post energy drink and placebo consumption)

Investigators

Sponsor
David Grant U.S. Air Force Medical Center
Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Sachin Shah

Assistant Professor of Pharmacy Practice

David Grant U.S. Air Force Medical Center

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