Effects of Energy Drinks on Sleep and Cardiovascular Health

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: Completed
• Conditions: Healthy; Caffeine
• Intervention / Treatment: Other: Energy Drink; Other: Placebo Drink

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in resting heart rate	Seated heart rate	Baseline and AM of day 2
Changes in resting blood pressure	Seated systolic and diastolic blood pressure	Baseline and AM of day 2

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Anna Svatikova, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 6, 2024
• Study Completion (Actual): September 6, 2024

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Energy Drink
• Other Study ID 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