Impact of Energy Drinks on Cardiovascular Endpoints

NCT ID: NCT01329679

Last Updated: 2020-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Energy Drink

Energy drink, 2 oz twice daily for 7 days

Group Type EXPERIMENTAL

Energy Drink

Intervention Type DIETARY_SUPPLEMENT

Energy drink, 2oz twice daily for 7 days

Placebo

Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Water, lime juice and cherry flavoring

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Energy Drink

Energy drink, 2oz twice daily for 7 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

Water, lime juice and cherry flavoring

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Water, lime juice and cherry flavoring

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

David Grant U.S. Air Force Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sachin Shah

Assistant Professor of Pharmacy Practice

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shah Sachin, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

David Grant Medical Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FWH20110111H

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Energy Drinks
NCT02727920 COMPLETED NA
Energy Drinks and Vascular Function
NCT03324256 COMPLETED NA