Effects of Energy Drinks on Sleep and Cardiovascular Health

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503732
• Other study ID #: 21-012902
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: Rochester Cardiovascular Research Unit Preventive Team
• Phone: 507-538-7425
• Email: RSTCVRUPrevent[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caffeine
• Healthy

Intervention

Other:
• Energy Drink
Two 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed
• Placebo Drink
Two 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in resting heart rate	Seated heart rate	Baseline and AM of day 2
Other	Changes in resting blood pressure	Seated systolic and diastolic blood pressure	Baseline and AM of day 2
Primary	Changes in sleep efficiency	Time asleep / time in bed	Throughout duration of sleep on both nights (night 1 and night 2)
Primary	Changes in sleep continuity	Frequency of wakefulness after sleep initiation	Throughout duration of sleep on both nights (night 1 and night 2)
Primary	Changes in sleep architecture	Time spent in each stage of sleep	Throughout duration of sleep on both nights (night 1 and night 2)
Primary	QT segment	QT duration	Baseline, approximately 1 hour prior to energy drink consumption
Primary	QT segment	QT duration	Throughout duration of sleep on both nights (night 1 and night 2)
Primary	Atrial arrhythmias	Frequency of ectopic atrial beats	Baseline, approximately 1 hour prior to energy drink consumption
Primary	Atrial arrhythmias	Frequency of ectopic atrial beats	Throughout duration of sleep on both nights (night 1 and night 2)
Primary	Ventricular arrhythmias	Frequency of ectopic ventricular beats	Baseline, approximately 1 hour prior to energy drink consumption
Primary	Ventricular arrhythmias	Frequency of ectopic ventricular beats	Throughout duration of sleep on both nights (night 1 and night 2)
Secondary	Sympathetic activation quantified by changes in plasma norepinephrine	Plasma norepinephrine while supine	Baseline and AM of day 2
Secondary	Sympathetic activation quantified by changes in plasma epinephrine	Plasma epinephrine while supine	Baseline and AM of day 2
Secondary	Sympathetic activation quantified by changes in plasma dopamine	Plasma dopamine while supine	Baseline and AM of day 2
Secondary	Sympathetic activation quantified by urine norepinephrine	Total urine norepinephrine secretion	Approximately 24 hours
Secondary	Sympathetic activation quantified by urine epinephrine	Total urine epinephrine secretion	Approximately 24 hours
Secondary	Sympathetic activation quantified by urine dopamine	Total urine dopamine secretion	Approximately 24 hours

External Links

•   Mayo Clinic Clinical Trials