NCT03418077

Brief Summary

The purpose of this study is to determine the effects of consuming an original flavor energy drink on electrocardiographic (ECG) and hemodynamic responses during and after exercise in healthy subjects. The effect of drinking an energy drink on exercise performance will also be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

January 25, 2018

Last Update Submit

April 16, 2020

Conditions

QTc Interval

Outcome Measures

Primary Outcomes (11)

  • Change in QTc interval

    QTc interval will be obtained by 12-lead ECG at baseline (prior to consumption of study drink), after consuming the drink and immediately following exercise and at 1, 4, 7 and 10 min following exercise while standing, and again at 30-minute intervals for a total of 2 hours (after being seated for 5 minutes prior) after exercise. Measures will be obtained at two visits (i.e., one visit for the placebo drink and one visit for the energy drink), separated by 4 - 14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in systolic BP (SBP)

    SBP will be obtained at baseline (prior to consumption of study drink), after consuming the drink and immediately following exercise, and at again at 30-minute intervals for a total of 2 hours (after being seated for 5 minutes prior) after exercise. Measures will be obtained at two visits (i.e., one visit for the placebo drink and one visit for the energy drink), separated by 4 - 14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in diastolic BP (DBP)

    DBP will be obtained at baseline (prior to consumption of study drink), after consuming the drink and immediately following exercise, and again at 30-minute intervals for a total of 2 hours (after being seated for 5 minutes prior) after exercise. Measures will be obtained at two visits (i.e., one visit for the placebo drink and one visit for the energy drink), separated by 4 - 14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in heart rate (HR)

    HR will be obtained at baseline (prior to consumption of study drink), after consuming the drink and immediately following exercise, and at 1, 4, 7 and 10 minutes (while standing), and again at 30-minute intervals for a total of 2 hours after exercise (seated for 5 minutes prior). Measures will be obtained at two visits (i.e., one visit for the placebo drink and one visit for the energy drink), separated by 4 - 14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in blood parameters - caffeine

    Blood samples for caffeine will be obtained from a Teflon intravenous catheter that will remain in place throughout the duration of the experiment. Blood samples will be taken at baseline (prior to consumption of study drink); after consuming drink and immediately upon cessation of exercise, and at one-and two-hours following exercise. Blood samples will be obtained at two visits, (i.e., one visit for the energy drink and one visit for the placebo drink), separated by 4-14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and respective p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in blood parameters - taurine

    Blood samples for taurine will be obtained from a Teflon intravenous catheter that will remain in place throughout the duration of the experiment. Blood samples will be taken at baseline (prior to consumption of study drink); after consuming drink and immediately upon cessation of exercise, and at one-and two-hours following exercise. Blood samples will be obtained at two visits, (i.e., one visit for the energy drink and one visit for the placebo drink), separated by 4-14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and respective p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in blood parameters - L-caritine

    Blood samples for L-carnitine will be obtained from a Teflon intravenous catheter that will remain in place throughout the duration of the experiment. Blood samples will be taken at baseline (prior to consumption of study drink); after consuming drink and immediately upon cessation of exercise, and at one-and two-hours following exercise. Blood samples will be obtained at two visits, (i.e., one visit for the energy drink and one visit for the placebo drink), separated by 4-14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and respective p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in blood parameters - plasma free fatty acids

    Blood samples for plasma free fatty acids will be obtained from a Teflon intravenous catheter that will remain in place throughout the duration of the experiment. Blood samples will be taken at baseline (prior to consumption of study drink); after consuming drink and immediately upon cessation of exercise, and at one-and two-hours following exercise. Blood samples will be obtained at two visits, (i.e., one visit for the energy drink and one visit for the placebo drink), separated by 4-14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and respective p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in blood parameters - glucose

    Blood samples for glucose will be obtained from a Teflon intravenous catheter that will remain in place throughout the duration of the experiment. Blood samples will be taken at baseline (prior to consumption of study drink); after consuming drink and immediately upon cessation of exercise, and at one-and two-hours following exercise. Blood samples will be obtained at two visits, (i.e., one visit for the energy drink and one visit for the placebo drink), separated by 4-14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and respective p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in blood parameters - lactate

    Blood samples for lactate will be obtained from a Teflon intravenous catheter that will remain in place throughout the duration of the experiment. Blood samples will be taken at baseline (prior to consumption of study drink); after consuming drink and immediately upon cessation of exercise, and at one-and two-hours following exercise. Blood samples will be obtained at two visits, (i.e., one visit for the energy drink and one visit for the placebo drink), separated by 4-14 days. The values for each participant at each time point will be combined to obtain the means and standard deviations. The appropriate test statistic and respective p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

  • Change in maximal exercise time to exhaustion

    After drink consumption, participants will perform a continuous, progressive treadmill or bicycle ergometer test until volitional exhaustion. Participants will be encouraged to perform their best during testing. Measures will be obtained on two days (i.e., one visit for the energy drink and one visit for the placebo drink), separated by 4 to 14 days. The values for each participant's maximal exercise time to exhaustion will be combined to obtain the means and standard deviations. The appropriate test statistic and p value will be reported to determine whether there was a statistically significant difference between the energy drink and placebo drink data

    3 hours

Study Arms (2)

energy drink

EXPERIMENTAL

Participants will serve as their own controls and have repeated measures obtained to determine if there is a difference between the placebo-control and energy drink arms

Dietary Supplement: Energy Drink

Placebo-control

PLACEBO COMPARATOR

Participants will serve as their own controls and have repeated measures obtained to determine if there is a difference between the placebo-control and energy drink arms

Dietary Supplement: Placebo-control

Interventions

Energy DrinkDIETARY_SUPPLEMENT

Participants will consume a randomly assigned single 24 oz can of an original flavor energy drink within a 30-minute period. Baseline ECG, HR, BP, blood sample and body weight will be obtained. Then perform a continuous, progressive treadmill or bicycle ergometry test until volitional exhaustion. ECG will be monitored continuously during exercise, rating of perceived exertion (RPE) will be recorded every minute of each workload increase. After completion of exercise, subject will remain standing on treadmill (or seated on ergometer) for 10 minutes while ECG, BP, HR and blood samples are obtained. Subsequent ECG measures will be obtained at 1,4,7 and 10 minutes. After 10 minutes, the subjects will be free to sit, stand or move quietly in the lab. During the 2-hour post exercise monitoring period, subject's ECG, HR, BP will be recorded at 30-minute intervals. Blood samples will be collected immediate upon cessation of exercise, at 1 and 2 hours post exercise

energy drink
Placebo-controlDIETARY_SUPPLEMENT

Participants will consume a randomly assigned single 24 oz can of control drink within a 30-minute period. Baseline ECG, HR, BP, blood sample and body weight will be obtained. Then perform a continuous, progressive treadmill or bicycle ergometry test until volitional exhaustion. ECG will be monitored continuously during exercise, rating of perceived exertion (RPE) will be recorded every minute of each workload increase. After completion of exercise, subject will remain standing on treadmill (or seated on ergometer) for 10 minutes while ECG, BP, HR and blood samples are obtained. Subsequent ECG measures will be obtained at 1,4,7 and 10 minutes. After 10 minutes, the subjects will be free to sit, stand or move quietly in the lab. During the 2-hour post exercise monitoring period, subject's ECG, HR, BP will be recorded at 30-minute intervals. Blood samples will be collected immediate upon cessation of exercise, at 1 and 2 hours post exercise

Placebo-control

Eligibility Criteria

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

You may qualify if:

  • Participants at David Grant Medical Center (DGMC): Healthy male and female, active duty military service members or Department of Defense (DoD) beneficiaries, who are eligible to receive care at DGMC. Participants at CSUS: Healthy male and female CSUS students.
  • Ages 18-40 years old
  • Participants must be willing to refrain from caffeine and energy drink use 48 hours prior to study days.

You may not qualify if:

  • Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, atherosclerosis, hypertension, palpitations, T-wave abnormalities, baseline corrected QT (QTc) interval greater than 440 milliseconds(msec). This will be determined on the ECG obtained during initial screening appointment, and reviewed by cardiologist and through the questionnaire responses of the participant.
  • Blood pressure at initial screening appointment or at baseline on study Day 1 greater than 130/80
  • Presence of any known medical condition, confirmed through participant interview. Examples of these are:
  • Hypertension
  • Thyroid disease
  • Type 1 or 2 diabetes mellitus
  • Recurrent headaches
  • Depression, currently receiving treatment (due to possible drug interactions)
  • Any psychiatric condition or neurological disorder
  • History of alcohol or drug abuse in the previous five years
  • Ever been diagnosed or told they have or had renal or hepatic dysfunction
  • Concurrent use of any medication taken on a daily basis, to include herbal products or supplements. Daily basis is defined as greater than two days per week.
  • Pregnant or lactating females will be excluded from participation with urine dipstick tests used to confirm pregnancy (pregnancy test performed before each treatment session).
  • All non-English speaking / writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
  • If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USAF David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

MeSH Terms

Interventions

Energy Drinks

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Troy D Chinevere

    David Grant Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 1, 2018

Study Start

May 7, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

US(1)