Clinical trial NCT05503732: Effects of Energy Drinks on Sleep and Cardiovascular Health
Official title: Effects of Energy Drinks on Sleep and Cardiovascular Health in Healthy Young Adults A Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Caffeine
Keywords: Energy Drink
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in sleep efficiency
timeFrame: Throughout duration of sleep on both nights (night 1 and night 2)
measure: Changes in sleep continuity
timeFrame: Throughout duration of sleep on both nights (night 1 and night 2)
measure: Changes in sleep architecture
timeFrame: Throughout duration of sleep on both nights (night 1 and night 2)
measure: QT segment
timeFrame: Baseline, approximately 1 hour prior to energy drink consumption
measure: QT segment
timeFrame: Throughout duration of sleep on both nights (night 1 and night 2)
measure: Atrial arrhythmias
timeFrame: Baseline, approximately 1 hour prior to energy drink consumption
measure: Atrial arrhythmias
timeFrame: Throughout duration of sleep on both nights (night 1 and night 2)
measure: Ventricular arrhythmias
timeFrame: Baseline, approximately 1 hour prior to energy drink consumption
measure: Ventricular arrhythmias
timeFrame: Throughout duration of sleep on both nights (night 1 and night 2)
Secondary outcomes:
measure: Sympathetic activation quantified by changes in plasma norepinephrine
timeFrame: Baseline and AM of day 2
measure: Sympathetic activation quantified by changes in plasma epinephrine
timeFrame: Baseline and AM of day 2
measure: Sympathetic activation quantified by changes in plasma dopamine
timeFrame: Baseline and AM of day 2
measure: Sympathetic activation quantified by urine norepinephrine
timeFrame: Approximately 24 hours
measure: Sympathetic activation quantified by urine epinephrine
timeFrame: Approximately 24 hours
measure: Sympathetic activation quantified by urine dopamine
timeFrame: Approximately 24 hours
Other outcomes:
measure: Changes in resting heart rate
timeFrame: Baseline and AM of day 2
measure: Changes in resting blood pressure
timeFrame: Baseline and AM of day 2
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Anna Svatikova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: