NCT03840863

Brief Summary

Many people use energy drinks (EDs) regularly, but the overall health concerns are still unknown. There are many energy drink products that contain a mixture of caffeine and other energy-boosting ingredients and supplements which can affect parameters related to the heart, blood pressure and blood glucose. Several previous studies have shown that energy drinks may affect heart rhythm and blood pressure significantly. As energy drinks are sugar-sweetened beverages, long-term use may also affect the body's metabolism, including cholesterol, blood sugars, and weight. The purpose of this study is to learn if drinking energy drinks everyday may affect a person's cardiometabolic health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

March 6, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

January 11, 2019

Last Update Submit

November 5, 2020

Conditions

Cardiovascular Diseases

Keywords

Energy DrinkBlood PressureArrhythmia

Outcome Measures

Primary Outcomes (2)

  • Change in blood pressure before and 1 hour after energy drink consumption

    Measuring acute changes in peripheral systolic blood pressure before and 1 hour after energy drink consumption

    1 hour

  • Change in blood pressure before and after 4 weeks of energy drink consumption

    Measuring chronic changes in peripheral systolic blood pressure before and 4 weeks after energy drink consumption

    4 weeks

Secondary Outcomes (7)

  • Change in QTc Interval before and after 1 hour of energy drink consumption

    1 hour

  • Change in QTc Interval before and after 4 weeks of energy drink consumption

    4 weeks

  • Change in fasting blood glucose before and after 4 weeks of energy drink consumption

    4 weeks

  • Change in fasting lipid panel parameters before and after 4 weeks of energy drink consumption

    4 weeks

  • Change in Body Mass Index before and after 4 weeks of energy drink consumption

    4 weeks

  • +2 more secondary outcomes

Study Arms (1)

Commercially-Available Energy drink

EXPERIMENTAL

Healthy volunteers willing to consume two cans of energy drinks (16 oz./can) daily for 4 weeks

Dietary Supplement: Commercially-Available Energy Drink

Interventions

Commercially-Available Energy DrinkDIETARY_SUPPLEMENT

Participant will consume 2 cans of an energy drink (16 oz./can) per day. One in the morning and one in the afternoon.

Commercially-Available Energy drink

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18 - 40 years
  • Participants willing to adhere to study drink schedule (28 days)

You may not qualify if:

  • Naïve caffeine consumers (\< 2 cups of coffee \[or equivalent caffeine intake\] per week)
  • Chronic medical conditions including cardiovascular disease (known history of cardiac arrhythmias, family history of premature sudden cardiac death before age 60, cardiomyopathy, atherosclerosis), smoking, renal or hepatic dysfunction
  • Prolonged corrected QT (QTc) interval
  • History of substance abuse, including alcohol
  • Concurrent use of prescription drugs or over-the-counter products that may interact with study drinks (with the exception of oral contraceptives that have been used for over 1 month)
  • Baseline Blood Pressure greater than 140/90 mmHg
  • Baseline fasting blood glucose greater than 126 mg/dL or random blood glucose greater than 200 mg/dL
  • Females only: pregnancy or lactation, or planning to get pregnant within next 28 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Pacific

Stockton, California, 95211, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • May Chen, PharmD

    University of the Pacific

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

February 15, 2019

Study Start

March 6, 2019

Primary Completion

June 20, 2019

Study Completion

July 30, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)