Effects of Energy Drinks on Sleep and Cardiovascular Health

NCT05503732 | Completed

• 1 other identifier: 21-012902
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Caffeine

Keywords

Energy Drink

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• Sympathetic activation quantified by changes in plasma norepinephrine

  Baseline and AM of day 2

• Sympathetic activation quantified by changes in plasma epinephrine

  Baseline and AM of day 2

• Sympathetic activation quantified by changes in plasma dopamine

  Baseline and AM of day 2

• Sympathetic activation quantified by urine norepinephrine

  Approximately 24 hours

• Sympathetic activation quantified by urine epinephrine

  Approximately 24 hours

Other Outcomes (2)

• Changes in resting heart rate

  Baseline and AM of day 2

• Changes in resting blood pressure

  Baseline and AM of day 2

Study Arms (2)

Energy drink first, then placebo drink

EXPERIMENTAL

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; Other: Placebo Drink

Placebo drink first, than energy drink

EXPERIMENTAL

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; Other: Placebo Drink

Interventions

Energy Drink OTHER

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

Energy drink first, then placebo drink; Placebo drink first, than energy drink

Placebo Drink OTHER

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

Energy drink first, then placebo drink; Placebo drink first, than energy drink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Energy Drinks

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Anna Svatikova, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: August 17, 2022
• Study Start: September 1, 2022
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

US (1)