Cardiovascular Effects of Energy Drinks in Healthy Adults

NCT ID: NCT01940822

Last Updated: 2022-05-18

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-11-30

Brief Summary

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This study is being done to look at the cardiovascular response, if any, to intake of commercially available energy drink. We hypothesize that energy drink consumption compared to a control drink in healthy adults alters the cardiovascular hemodynamic system.The focus of this study is to elucidate the physiological/cardiovascular response to an energy drink consumption as compared to a control drink both at rest and during stressful conditions in healthy adults.

Detailed Description

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The study will collect data to determine the hemodynamic changes (magnitude of heart rate and blood pressure response) in healthy adults after consumption of an energy drink and compare these responses to those after a control drink. Study will be performed at a hospital Clinical Research Unit on two separate days; minimum 24 hours and maximum 1 month apart. Participants will be fasting 4 hours prior to the study and will be asked to abstain from caffeine and alcohol for at least 24 hours prior to initiation of this study. Baseline measurements will be obtained during and after 10 minutes of rest. After the end of baseline recordings, the subjects will be given up to 500 ml (1 can, approximately 16 fluid ounces) of caffeinated energy drink or a control drink, based on randomization. They will have 30 minutes to drink it. The second set of measurements will be obtained after an energy drink or control drink intake, using exactly the same protocol as at baseline. The second study visit, participant will receive the alternate intervention.

Conditions

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Energy Drinks Hemodynamics Cardiovascular System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Energy drink first, then placebo drink

Participants will receive an energy drink at the first study visit, and a placebo drink at the second study visit.

Group Type EXPERIMENTAL

Energy Drink

Intervention Type OTHER

Placebo Drink

Intervention Type OTHER

Placebo drink first, then energy drink

Participants will receive a placebo drink at the first study visit and an Energy Drink at the second study visit.

Group Type EXPERIMENTAL

Energy Drink

Intervention Type OTHER

Placebo Drink

Intervention Type OTHER

Interventions

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Energy Drink

Intervention Type OTHER

Placebo Drink

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 and/or thyroid disease
* Subjects currently taking medications other than oral contraceptive pill
* Smokers
* Prior history of caffeine sensitivity or allergy
* Pregnancy
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

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Svatikova, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Svatikova A, Covassin N, Somers KR, Somers KV, Soucek F, Kara T, Bukartyk J. A Randomized Trial of Cardiovascular Responses to Energy Drink Consumption in Healthy Adults. JAMA. 2015 Nov 17;314(19):2079-82. doi: 10.1001/jama.2015.13744. No abstract available.

Reference Type RESULT
PMID: 26547226 (View on PubMed)

Related Links

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Other Identifiers

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13-001918

Identifier Type: -

Identifier Source: org_study_id

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