Effects of Energy Drinks on Sleep and Cardiovascular Health

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy, Caffeine

Intervention / Treatment
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* Other: Energy Drink
* Other: Placebo Drink


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy drink first, then placebo drink<br>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<br>* Two 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed<br>Other: Placebo Drink<br>* Two 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed<br>|
| Experimental: Placebo drink first, than energy drink<br>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<br>* Two 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed<br>Other: Placebo Drink<br>* Two 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy Drink