Cardiovascular DiseasesNCT06330649
The Acute Effect of and Energy Drink vs. Water Consumption on MAP, HR, and Energy Metabolism
A study testing Energy Drink in people with Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington at 1 site in United States.
Trial summary
The objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Diet
- What is being tested?
- Energy Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Sep 2024
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between ages 18-30
- Must be free of reported cardiovascular, respiratory, and metabolic diseases.
- Must be caffeine naïve
- Must be fasted
Who cannot join
- Food allergies
- pregnant women
- Breast feeding women
- Individuals with cardiac, cardiovascular, respiratory, metabolic, and/or neurological disorders
- taking any prescription vasoactive medications
- allergies to spandex/lycra
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Arlington - Science and Engineering Innovation and Research Building
Arlington, Texas, 76019
About this study
The objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism
Read the detailed description
Energy drink consumption has gained a lot in popularity and represents one of the most rapidly growing segments of the beverage industry. While regularly discussed in media outlets etc. the cardiovascular effects are not well described or well known. For example, the impacts on various cardiovascular parameters range from improved, decreased, to not impacted at all depending on the source. This can be due to a number of reasons including, study protocol design, study population tested, energy drink product used, volume consumed, etc. Accordingly, this study aims to investigate the impact of acute consumption of a standard commercially available can of energy drink beverage on the following parameters.
- Arterial blood pressure
- Heart rate
- Energy metabolism (oxygen consumption and carbon dioxide production
It is hypothesized that consumption of a 12 oz energy drink will result in modest elevations in arterial blood pressure, heart rate, and energy metabolism relative to when consuming of an equal volume of water.
- Conditions
- Cardiovascular Diseases, Hypertension, Diet
- Being tested
- Energy Drink, Water Control
- Keywords
- Energy metabolism, Arterial blood pressure, heart rate
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy DrinkDietary supplement
This is a commercially available energy drink
Water ControlOther
This is a commercially available bottled water
| Study group | Role | What they receive |
|---|---|---|
| Energy Drink | Experimental | A commercially available caffeine drink containing 200 mgs of caffeine. Receives: Dietary Supplement: Energy Drink |
| Water | Placebo comparator | This will be 12 fl oz of commercially available water . Receives: Other: Water Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood pressure in millimeters of mercury
blood pressure will be measured on the upper arm using standard procedures that are done in a doctors office.
Measured: baseline & 30, 60, 90, 120 min following beverage consumption
Oxygen consumption milliliters per kilogram of body weight per minute
This will be assessed using a metabolic cart to measure the amount of oxygen that is consumed by the body.
Measured: baseline & 30, 60, 90, 120 min following beverage consumption
Heart rate in beats per minute
Heart will be measured using an electrocardiogram procedures that are done in a doctors office.
Measured: baseline & 30, 60, 90, 120 min following beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Individuals will be randomly assigned to either an experimental or a control condition.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Brothers, The University of Texas at Arlington
- Investigators
- Robert M Brothers, PhD, Principal investigator, University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330649
- Sponsor's protocol ID
- 2024-0095
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of and Energy Drink vs. Water Consumption on MAP, HR, and Energy Metabolism
- ClinicalTrials.gov ID
- NCT06330649
- Acronym / sponsor ID
- 2024-0095
- Conditions
- Cardiovascular Diseases, Hypertension, Diet
- Keywords
- Energy metabolism, Arterial blood pressure, heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 26 Mar 2024 (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 objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism
Detailed description
Energy drink consumption has gained a lot in popularity and represents one of the most rapidly growing segments of the beverage industry. While regularly discussed in media outlets etc. the cardiovascular effects are not well described or well known. For example, the impacts on various cardiovascular parameters range from improved, decreased, to not impacted at all depending on the source. This can be due to a number of reasons including, study protocol design, study population tested, energy drink product used, volume consumed, etc. Accordingly, this study aims to investigate the impact of acute consumption of a standard commercially available can of energy drink beverage on the following parameters.
- Arterial blood pressure
- Heart rate
- Energy metabolism (oxygen consumption and carbon dioxide production
It is hypothesized that consumption of a 12 oz energy drink will result in modest elevations in arterial blood pressure, heart rate, and energy metabolism relative to when consuming of an equal volume of water.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned to either an experimental or a control condition.
| Arm | Type | Receives |
|---|---|---|
| Energy Drink | Experimental | Dietary Supplement: Energy DrinkA commercially available caffeine drink containing 200 mgs of caffeine. |
| Water | Placebo comparator | Other: Water ControlThis will be 12 fl oz of commercially available water . |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between ages 18-30
- Must be free of reported cardiovascular, respiratory, and metabolic diseases.
- Must be caffeine naïve
- Must be fasted
Key exclusion criteria (6 listed)
- Food allergies
- pregnant women
- Breast feeding women
- Individuals with cardiac, cardiovascular, respiratory, metabolic, and/or neurological disorders
- taking any prescription vasoactive medications
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 DrinkThis is a commercially available energy drink | Dietary supplement | Energy Drink |
| Water ControlThis is a commercially available bottled water | Other | Water |
Primary outcome
Peripheral blood pressure in millimeters of mercury
Time frame: baseline & 30, 60, 90, 120 min following beverage consumption
blood pressure will be measured on the upper arm using standard procedures that are done in a doctors office.
Oxygen consumption milliliters per kilogram of body weight per minute
Time frame: baseline & 30, 60, 90, 120 min following beverage consumption
This will be assessed using a metabolic cart to measure the amount of oxygen that is consumed by the body.
Heart rate in beats per minute
Time frame: baseline & 30, 60, 90, 120 min following beverage consumption
Heart will be measured using an electrocardiogram procedures that are done in a doctors office.
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 1 Apr 2025.
- Individual participant dataSharing planned: No. There is not a plan to share IPD.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Robert M Brothers, PhD principal investigator
University of Texas at Arlington
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 Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington 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 4 inclusion and 6 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 1 Apr 2025. 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?
Peripheral blood pressure in millimeters of mercury (time frame: baseline & 30, 60, 90, 120 min following beverage consumption). The study lists 3 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 1 Apr 2025.