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OpenTrials
Completed

NCT Number: NCT05503732

Effects of Energy Drinks on Sleep and Cardiovascular Health

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.

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Key information

Conditions

Healthy Caffeine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Energy drink

Other

Two 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed

Placebo drink

Other

Two 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed

Primary outcomes

  1. Changes in sleep efficiency

    Time frame: Throughout duration of sleep on both nights (night 1 and night 2)

    Time asleep / time in bed

  2. Changes in sleep continuity

    Time frame: Throughout duration of sleep on both nights (night 1 and night 2)

    Frequency of wakefulness after sleep initiation

  3. Changes in sleep architecture

    Time frame: Throughout duration of sleep on both nights (night 1 and night 2)

    Time spent in each stage of sleep

  4. QT segment

    Time frame: Baseline, approximately 1 hour prior to energy drink consumption

    QT duration

  5. QT segment

    Time frame: Throughout duration of sleep on both nights (night 1 and night 2)

    QT duration

  6. Atrial arrhythmias

    Time frame: Baseline, approximately 1 hour prior to energy drink consumption

    Frequency of ectopic atrial beats

  7. Atrial arrhythmias

    Time frame: Throughout duration of sleep on both nights (night 1 and night 2)

    Frequency of ectopic atrial beats

  8. Ventricular arrhythmias

    Time frame: Baseline, approximately 1 hour prior to energy drink consumption

    Frequency of ectopic ventricular beats

  9. Ventricular arrhythmias

    Time frame: Throughout duration of sleep on both nights (night 1 and night 2)

    Frequency of ectopic ventricular beats

Secondary outcomes

  1. Sympathetic activation quantified by changes in plasma norepinephrine

    Time frame: Baseline and AM of day 2

    Plasma norepinephrine while supine

  2. Sympathetic activation quantified by changes in plasma epinephrine

    Time frame: Baseline and AM of day 2

    Plasma epinephrine while supine

  3. Sympathetic activation quantified by changes in plasma dopamine

    Time frame: Baseline and AM of day 2

    Plasma dopamine while supine

  4. Sympathetic activation quantified by urine norepinephrine

    Time frame: Approximately 24 hours

    Total urine norepinephrine secretion

  5. Sympathetic activation quantified by urine epinephrine

    Time frame: Approximately 24 hours

    Total urine epinephrine secretion

  6. Sympathetic activation quantified by urine dopamine

    Time frame: Approximately 24 hours

    Total urine dopamine secretion

Other outcomes

  1. Changes in resting heart rate

    Time frame: Baseline and AM of day 2

    Seated heart rate

  2. Changes in resting blood pressure

    Time frame: Baseline and AM of day 2

    Seated systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2022
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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