Effects of Energy Drinks on Sleep and Cardiovascular Health

November 13, 2024 updated by: Anna Svatikova, Mayo Clinic

Effects of Energy Drinks on Sleep and Cardiovascular Health in Healthy Young Adults A Double Blind Randomized Clinical Trial

The purpose of this study is to learn about the change in quality of sleep, structural organization of sleep, and cardiovascular responses after consuming an energy drink compared to a placebo drink with no caffeine or stimulants.

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.

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.
54

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rochester Cardiovascular Research Unit Preventive Team
  • Phone Number: 507-538-7425
  • Email: RSTCVRUPrevent@mayo.edu

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults 18 years of age and older.
  • Healthy subjects without known cardiovascular disease and thyroid disease.
  • Subjects who are on no medications (except oral contraceptive pill).
  • Nonsmokers.
  • No prior history of caffeine sensitivity or allergy.

Exclusion Criteria:

  • Subjects with known cardiovascular or thyroid disease.
  • Subjects currently taking medications other than oral contraceptive pill.
  • Smokers.
  • Prior history of caffeine sensitivity or allergy.
  • Pregnancy.
  • Subjects who regularly consume energy drinks.
  • Subjects who typically go to sleep after midnight.
  • Subjects who traveled across 2 time zones in the last 7 days.
  • Shift workers.
  • Subjects who have or are suspected to have sleep apnea.
  • Subjects who have a body mass index > 35kg/m^2.

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: Prevention
  • 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.
Experimental: Energy drink first, then placebo drink
Subjects will consume two 16-oz energy drinks before sleep for the first study visit, then consume two 16-oz identical looking placebo drink before sleep at the second study visit.
Other: Energy Drink
Two 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed
Other: Placebo Drink
Two 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed
Experimental: Placebo drink first, than energy drink
Subjects will consume two 16-oz identical looking placebo drink before sleep at the fist study visit, then consume two 16-oz energy drinks before sleep for the second study visit.
Other: Energy Drink
Two 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed
Other: Placebo Drink
Two 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed

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
Changes in sleep efficiency
Time Frame: Throughout duration of sleep on both nights (night 1 and night 2)
Time asleep / time in bed
Throughout duration of sleep on both nights (night 1 and night 2)
Changes in sleep continuity
Time Frame: Throughout duration of sleep on both nights (night 1 and night 2)
Frequency of wakefulness after sleep initiation
Throughout duration of sleep on both nights (night 1 and night 2)
Changes in sleep architecture
Time Frame: Throughout duration of sleep on both nights (night 1 and night 2)
Time spent in each stage of sleep
Throughout duration of sleep on both nights (night 1 and night 2)
QT segment
Time Frame: Baseline, approximately 1 hour prior to energy drink consumption
QT duration
Baseline, approximately 1 hour prior to energy drink consumption
QT segment
Time Frame: Throughout duration of sleep on both nights (night 1 and night 2)
QT duration
Throughout duration of sleep on both nights (night 1 and night 2)
Atrial arrhythmias
Time Frame: Baseline, approximately 1 hour prior to energy drink consumption
Frequency of ectopic atrial beats
Baseline, approximately 1 hour prior to energy drink consumption
Atrial arrhythmias
Time Frame: Throughout duration of sleep on both nights (night 1 and night 2)
Frequency of ectopic atrial beats
Throughout duration of sleep on both nights (night 1 and night 2)
Ventricular arrhythmias
Time Frame: Baseline, approximately 1 hour prior to energy drink consumption
Frequency of ectopic ventricular beats
Baseline, approximately 1 hour prior to energy drink consumption
Ventricular arrhythmias
Time Frame: Throughout duration of sleep on both nights (night 1 and night 2)
Frequency of ectopic ventricular beats
Throughout duration of sleep on both nights (night 1 and night 2)

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
Sympathetic activation quantified by changes in plasma norepinephrine
Time Frame: Baseline and AM of day 2
Plasma norepinephrine while supine
Baseline and AM of day 2
Sympathetic activation quantified by changes in plasma epinephrine
Time Frame: Baseline and AM of day 2
Plasma epinephrine while supine
Baseline and AM of day 2
Sympathetic activation quantified by changes in plasma dopamine
Time Frame: Baseline and AM of day 2
Plasma dopamine while supine
Baseline and AM of day 2
Sympathetic activation quantified by urine norepinephrine
Time Frame: Approximately 24 hours
Total urine norepinephrine secretion
Approximately 24 hours
Sympathetic activation quantified by urine epinephrine
Time Frame: Approximately 24 hours
Total urine epinephrine secretion
Approximately 24 hours
Sympathetic activation quantified by urine dopamine
Time Frame: Approximately 24 hours
Total urine dopamine secretion
Approximately 24 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in resting heart rate
Time Frame: Baseline and AM of day 2
Seated heart rate
Baseline and AM of day 2
Changes in resting blood pressure
Time Frame: Baseline and AM of day 2
Seated systolic and diastolic blood pressure
Baseline and AM of day 2

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.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anna Svatikova, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
September 1, 2022

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.
September 6, 2024

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.
September 6, 2024

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).
July 14, 2022

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.
August 15, 2022

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.
August 17, 2022

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.
November 15, 2024

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.
November 13, 2024

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.
November 1, 2024

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.
  • 21-012902

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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