Effects of Energy Drinks on Sleep and Cardiovascular Health

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05503732
Collaborator
(none)
30
1
2
16
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Energy Drink
  • Other: Placebo Drink
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Effects of Energy Drinks on Sleep and Cardiovascular Health in Healthy Young Adults A Double Blind Randomized Clinical Trial
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Changes in sleep efficiency [Throughout duration of sleep on both nights (night 1 and night 2)]

    Time asleep / time in bed

  2. Changes in sleep continuity [Throughout duration of sleep on both nights (night 1 and night 2)]

    Frequency of wakefulness after sleep initiation

  3. Changes in sleep architecture [Throughout duration of sleep on both nights (night 1 and night 2)]

    Time spent in each stage of sleep

  4. QT segment [Baseline, approximately 1 hour prior to energy drink consumption]

    QT duration

  5. QT segment [Throughout duration of sleep on both nights (night 1 and night 2)]

    QT duration

  6. Atrial arrhythmias [Baseline, approximately 1 hour prior to energy drink consumption]

    Frequency of ectopic atrial beats

  7. Atrial arrhythmias [Throughout duration of sleep on both nights (night 1 and night 2)]

    Frequency of ectopic atrial beats

  8. Ventricular arrhythmias [Baseline, approximately 1 hour prior to energy drink consumption]

    Frequency of ectopic ventricular beats

  9. Ventricular arrhythmias [Throughout duration of sleep on both nights (night 1 and night 2)]

    Frequency of ectopic ventricular beats

Secondary Outcome Measures

  1. Sympathetic activation quantified by changes in plasma norepinephrine [Baseline and AM of day 2]

    Plasma norepinephrine while supine

  2. Sympathetic activation quantified by changes in plasma epinephrine [Baseline and AM of day 2]

    Plasma epinephrine while supine

  3. Sympathetic activation quantified by changes in plasma dopamine [Baseline and AM of day 2]

    Plasma dopamine while supine

  4. Sympathetic activation quantified by urine norepinephrine [Approximately 24 hours]

    Total urine norepinephrine secretion

  5. Sympathetic activation quantified by urine epinephrine [Approximately 24 hours]

    Total urine epinephrine secretion

  6. Sympathetic activation quantified by urine dopamine [Approximately 24 hours]

    Total urine dopamine secretion

Other Outcome Measures

  1. Changes in resting heart rate [Baseline and AM of day 2]

    Seated heart rate

  2. Changes in resting blood pressure [Baseline and AM of day 2]

    Seated systolic and diastolic blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Anna Svatikova, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05503732
Other Study ID Numbers:
  • 21-012902
First Posted:
Aug 17, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anna Svatikova, Principal Investigator, Mayo Clinic

Study Results

No Results Posted as of Aug 23, 2022