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Impact of Energy Drink Brands on Heart Rhythm

NCT ID: NCT03196908

Last Updated: 2018-12-24

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-12-30

Brief Summary

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To assess the cardiac effects of energy drink brands in healthy volunteers

Detailed Description

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Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.

Conditions

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Electrical Alternation of Heart Blood Pressure

Keywords

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ECG Blood Pressure Energy Drinks

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 Brand 1

Two 16-oz bottles of Energy Drink Brand 1

Group Type EXPERIMENTAL

Energy Drink Brand 1

Intervention Type DIETARY_SUPPLEMENT

Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes

Energy Drink Brand 2

Two 16-oz bottles of Energy Drink Brand 2

Group Type EXPERIMENTAL

Energy Drink Brand 2

Intervention Type DIETARY_SUPPLEMENT

Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes

Placebo

Two 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Lime juice, water, and cherry flavoring

Interventions

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Energy Drink Brand 1

Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes

Intervention Type DIETARY_SUPPLEMENT

Energy Drink Brand 2

Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes

Intervention Type DIETARY_SUPPLEMENT

Placebo

Lime juice, water, and cherry flavoring

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female adults 18 - 40 years old
* Participants must be willing to refrain from caffeine and alcohol use ≥48 hours prior to sessions on Day 1, 8, and 15

Exclusion Criteria

* Presence of any known medical condition confirmed through participant interview
* QTc interval greater than 450 milliseconds (ms).
* Blood pressure greater than 140/90 mmHg.
* Current smokers
* Concurrent use of prescription, over-the-counter (OTC) or herbal supplements taken on a daily basis (except oral contraceptives).
* Pregnant or currently breast-feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of the Pacific

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sachin Shah, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of the Pacific

Locations

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University of the Pacific

Stockton, California, United States

Site Status

Countries

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United States

References

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Shah SA, Szeto AH, Farewell R, Shek A, Fan D, Quach KN, Bhattacharyya M, Elmiari J, Chan W, O'Dell K, Nguyen N, McGaughey TJ, Nasir JM, Kaul S. Impact of High Volume Energy Drink Consumption on Electrocardiographic and Blood Pressure Parameters: A Randomized Trial. J Am Heart Assoc. 2019 Jun 4;8(11):e011318. doi: 10.1161/JAHA.118.011318. Epub 2019 May 29.

Reference Type DERIVED
PMID: 31137991 (View on PubMed)

Other Identifiers

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17-109

Identifier Type: -

Identifier Source: org_study_id