QTc IntervalNCT03418077
Post-Exercise Cardiovascular Responses Following Energy Drink Consumption
A study testing Energy Drink in people with QTc Interval, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- QTc Interval
- What is being tested?
- Energy Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
USAF David Grant Medical Center
Travis Air Force Base, California, 94535
About this study
Official title: Post-Exercise Cardiovascular Responses Following Energy Drink Consumption in Young, Healthy Adults
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.
Read the detailed description
The study will employ a double-blinded, randomized, crossover design to evaluate the cardiovascular (CV) effects of an energy drink during post-exercise recovery. Subjects who express interest in the study will be screen for eligibility. Those who are eligible will be consented. An inquire into usual caffeine intake to assess caffeine naïve or caffeine tolerant. Participants height, weight and race will be recorded. A resting 12-lead baseline ECG and blood pressure (BP) will be obtained to rule out CV anomalies. A cardiologist will review every baseline ECG and BP reading to rule out everything but a normal sinus rhythm and BP < 130/80 mmHg. Subjects who meet inclusion criteria and are approved by the cardiologist will be enrolled and allocated a randomized participant identification (ID) number. They will be given the "Participant Instruction Sheet"
Participants will be randomly assigned, blinded to consume a single 24 oz container of an energy drink or a 24 oz container of a control drink. Participants will serve as their own controls, so they will undergo testing in the experimental and control drink conditions, separated by 4 to 14 day. Each 24 oz control drink will be comprised of 585 ml of carbonated water, 30 ml of reconstituted lime juice and 105 ml of cherry flavoring. This control drink formula is identical to that used by Fletcher et al. (2017). The carbohydrate content of the 24 oz control drink is 81 g, which is the same as the 81 g per 24 oz energy drink. Participants will fast 12 hours, asked to refrain from vigorous exercised 24-hours, and abstain from caffeine consumption 48-hours prior to consuming a randomly assigned single 24 oz can of an original flavor energy drink within a 30-minute period. Investigator and participant will be blinded.
Subjects will be asked to visit either Heart, Lung and Vascular clinic or exercised physiology laboratory (CSUS subjects) twice, separated by 4-14 days to undergo testing. ECG electrodes will be placed on the upper torso and remain in place throughout the experiment. Baseline ECG, HR, BP, blood sample and body weight will be obtained. Catheter placement and blood draws will be performed by a registered clinical cardiopulmonary technician, registered nurse or a resident physician. Approximately 20 mil of blood will be taken at each time point.
Subjects will perform a continuous, progressive treadmill or bicycle ergometry test until volitional exhaustion. The treadmill test will begin with walking at 3.4 mph at 0% grade, then speed increased to 7 mph (males) or 6 mph (females) and grade increased by 2.5% every 2 minutes until > 85% ag-predicted maximum heart rate and volitional exhaustion has been reached. Subjects performing the ergometry test will being cycling at a resistance of 100 W for 2 minutes with the resistance increased by 25 W (males) or 15 W (females), each minute thereafter. Maximum HR will be calculated using the Tanaka formula (Tanaka et al., 2001). A 12-lead ECG will remain in place on subject and monitored continuously during exercise, and 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 for caffeine, taurine, L-carnitine, plasma free fatty acids, glucose and lactate will be collected immediate upon cessation of exercise, at 1 and 2 hours post exercise.
- Conditions
- QTc Interval
- Being tested
- Energy Drink, Placebo-control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start7 May 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QTc IntervalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Troy D Chinevere, Principal investigator, David Grant Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418077
- Sponsor's protocol ID
- FDG20180006H
- Status last verified
- Apr 2020
- First submitted
- 25 Jan 2018
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Exercise Cardiovascular Responses Following Energy Drink Consumption in Young, Healthy Adults
- ClinicalTrials.gov ID
- NCT03418077
- Acronym / sponsor ID
- FDG20180006H
- Conditions
- QTc Interval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- 7 May 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will employ a double-blinded, randomized, crossover design to evaluate the cardiovascular (CV) effects of an energy drink during post-exercise recovery. Subjects who express interest in the study will be screen for eligibility. Those who are eligible will be consented. An inquire into usual caffeine intake to assess caffeine naïve or caffeine tolerant. Participants height, weight and race will be recorded. A resting 12-lead baseline ECG and blood pressure (BP) will be obtained to rule out CV anomalies. A cardiologist will review every baseline ECG and BP reading to rule out everything but a normal sinus rhythm and BP < 130/80 mmHg. Subjects who meet inclusion criteria and are approved by the cardiologist will be enrolled and allocated a randomized participant identification (ID) number. They will be given the "Participant Instruction Sheet"
Participants will be randomly assigned, blinded to consume a single 24 oz container of an energy drink or a 24 oz container of a control drink. Participants will serve as their own controls, so they will undergo testing in the experimental and control drink conditions, separated by 4 to 14 day. Each 24 oz control drink will be comprised of 585 ml of carbonated water, 30 ml of reconstituted lime juice and 105 ml of cherry flavoring. This control drink formula is identical to that used by Fletcher et al. (2017). The carbohydrate content of the 24 oz control drink is 81 g, which is the same as the 81 g per 24 oz energy drink. Participants will fast 12 hours, asked to refrain from vigorous exercised 24-hours, and abstain from caffeine consumption 48-hours prior to consuming a randomly assigned single 24 oz can of an original flavor energy drink within a 30-minute period. Investigator and participant will be blinded.
Subjects will be asked to visit either Heart, Lung and Vascular clinic or exercised physiology laboratory (CSUS subjects) twice, separated by 4-14 days to undergo testing. ECG electrodes will be placed on the upper torso and remain in place throughout the experiment. Baseline ECG, HR, BP, blood sample and body weight will be obtained. Catheter placement and blood draws will be performed by a registered clinical cardiopulmonary technician, registered nurse or a resident physician. Approximately 20 mil of blood will be taken at each time point.
Subjects will perform a continuous, progressive treadmill or bicycle ergometry test until volitional exhaustion. The treadmill test will begin with walking at 3.4 mph at 0% grade, then speed increased to 7 mph (males) or 6 mph (females) and grade increased by 2.5% every 2 minutes until > 85% ag-predicted maximum heart rate and volitional exhaustion has been reached. Subjects performing the ergometry test will being cycling at a resistance of 100 W for 2 minutes with the resistance increased by 25 W (males) or 15 W (females), each minute thereafter. Maximum HR will be calculated using the Tanaka formula (Tanaka et al., 2001). A 12-lead ECG will remain in place on subject and monitored continuously during exercise, and 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 for caffeine, taurine, L-carnitine, plasma free fatty acids, glucose and lactate will be collected immediate upon cessation of exercise, at 1 and 2 hours post exercise.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| energy drink | Experimental | Dietary Supplement: Energy DrinkParticipants 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 |
| Placebo-control | Placebo comparator | Dietary Supplement: Placebo-controlParticipants 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy DrinkParticipants 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 | Dietary supplement | energy drink |
| Placebo-controlParticipants 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 | Dietary supplement | Placebo-control |
Primary outcome
Change in QTc interval
Time frame: 3 hours
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
Change in systolic BP (SBP)
Time frame: 3 hours
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
Change in diastolic BP (DBP)
Time frame: 3 hours
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
Change in heart rate (HR)
Time frame: 3 hours
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
Change in blood parameters - caffeine
Time frame: 3 hours
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
Change in blood parameters - taurine
Time frame: 3 hours
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
Change in blood parameters - L-caritine
Time frame: 3 hours
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
Change in blood parameters - plasma free fatty acids
Time frame: 3 hours
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
Change in blood parameters - glucose
Time frame: 3 hours
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
Change in blood parameters - lactate
Time frame: 3 hours
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
Change in maximal exercise time to exhaustion
Time frame: 3 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troy D Chinevere principal investigator
David Grant Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Drink in people with QTc Interval, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QTc interval (time frame: 3 hours). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.