Energy Drinks and Vascular Function

May 16, 2019 updated by: University of Florida

Acute Effect of Energy Drinks on Vascular Function

The purpose of this study will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The use of energy products has significantly increased in the last few years and is especially high among young men. The present study will compare the acute effect of a commercially available energy drink, energy gum, coffee and control beverage on endothelial function, arterial stiffness and circulating markers of thrombosis, inflammation and oxidative stress.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Being Male
  • 18-30 years of age
  • No indication of major clinical disease (e.g. diabetes, hypertension, significant arrhythmias, syncope and cardiovascular disease)
  • BMI ≤ 30 kg/m^2 and blood pressure ≤ 140/90 mmHg
  • Consumption of <400mg of caffeine/day
  • Prior history of consumption of energy drinks

Exclusion criteria:

  • Being female
  • Age <18 or >30 years
  • BMI> 30 kg/m^2 and blood pressure > 140/90 mmHg
  • Use of medication that may affect vascular measures
  • Use of tobacco products including smoking
  • Vegan or vegetarian diet
  • Being energy drink or caffeine naïve or consumption of >400 mg of caffeine/day
  • Consumption of >1 energy drinks per month
  • Being a shift worker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Energy drink and placebo gum
Commercially-available energy drink (16oz) + 2 pieces of placebo gum
Other: energy drink
16 oz cold commercially-available energy drink
Other: placebo gum
2 pieces of commercially-available placebo gum
Active Comparator: Caffeinated drink and placebo gum
Commercially-available caffeinated drink (16oz) + 2 pieces of placebo gum
Other: placebo gum
2 pieces of commercially-available placebo gum
Other: caffeinated drink
16oz cold commercially-available caffeinated drink
Active Comparator: Control drink and energy gum
Control drink (16oz) + 2 pieces of energy gum
Other: Energy gum
2 pieces of commercially-available energy gum
Other: Control drink
16oz cold control drink
Placebo Comparator: Control drink and placebo gum
Control drink (16oz) + 2 pieces of placebo gum
Other: placebo gum
2 pieces of commercially-available placebo gum
Other: Control drink
16oz cold control drink
Active Comparator: Energy drink and total sleep deprivation
Commercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation
Other: energy drink
16 oz cold commercially-available energy drink
Other: placebo gum
2 pieces of commercially-available placebo gum
Other: Total sleep deprivation
24-hour total sleep deprivation prior to consumption of energy drink and placebo gum

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in endothelial function
Time Frame: Before and 1 and 2 hrs following consumption of drink and gum
Brachial artery flow-mediated dilation
Before and 1 and 2 hrs following consumption of drink and gum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in arterial stiffness
Time Frame: Before and 1 and 2 hrs following consumption of drink and gum
Carotid to femoral pulse wave velocity
Before and 1 and 2 hrs following consumption of drink and gum
Change in wave reflection
Time Frame: Before and 1 and 2 hrs following consumption of drink and gum
Augmentation index
Before and 1 and 2 hrs following consumption of drink and gum
Change in peripheral and central blood pressures
Time Frame: Before and 1 and 2 hrs following consumption of drink and gum
Brachial and aortic blood pressures
Before and 1 and 2 hrs following consumption of drink and gum
Change in thrombosis and platelet function
Time Frame: Before and 1 and 2 hrs following consumption of drink and gum
Thromboelastograph and platelet aggregation tests
Before and 1 and 2 hrs following consumption of drink and gum
Change in circulating factors related to vascular function
Time Frame: Before and 1 and 2 hrs following consumption of drink and gum
Circulating levels of Trimethylamine N-oxide (TMAO) and markers of oxidative stress and inflammation
Before and 1 and 2 hrs following consumption of drink and gum
Change in heart rhythm
Time Frame: Before and 1 and 2 hrs following consumption of drink and gum
Electrocardiogram
Before and 1 and 2 hrs following consumption of drink and gum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201700678

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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