Effects of Energy Drinks on Sleep and Cardiovascular Health

NCT ID: NCT05503732

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-09-06

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Caffeine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Energy Drink

Intervention Type OTHER

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

Placebo Drink

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Energy Drink

Intervention Type OTHER

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

Placebo Drink

Intervention Type OTHER

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

Interventions

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Energy Drink

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

Intervention Type OTHER

Placebo Drink

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Anna Svatikova

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Svatikova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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21-012902

Identifier Type: -

Identifier Source: org_study_id

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