Effects of Energy Drinks on Sleep and Cardiovascular Health

Not Applicable

Completed

• Conditions: Healthy; Caffeine
• Interventions: Other: Energy Drink; Other: Placebo Drink

• Registration Number: NCT05503732
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2022-09-01
• Primary Completion: 2024-09-06
• Study Completion: 2024-09-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo drink first, than energy drink	Placebo 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.
Energy drink first, then placebo drink	Energy 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.
Energy drink first, then placebo drink	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.
Placebo drink first, than energy drink	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.

Primary Outcome Measures

Name	Time	Method
Atrial arrhythmias	Throughout duration of sleep on both nights (night 1 and night 2)	Frequency of ectopic atrial beats
Changes in sleep continuity	Throughout duration of sleep on both nights (night 1 and night 2)	Frequency of wakefulness after sleep initiation
Changes in sleep architecture	Throughout duration of sleep on both nights (night 1 and night 2)	Time spent in each stage of sleep
QT segment	Throughout duration of sleep on both nights (night 1 and night 2)	QT duration
Changes in sleep efficiency	Throughout duration of sleep on both nights (night 1 and night 2)	Time asleep / time in bed
Ventricular arrhythmias	Throughout duration of sleep on both nights (night 1 and night 2)	Frequency of ectopic ventricular beats

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States