Cardiovascular DiseasesNCT03840863
Effects of Chronic Energy Drink Consumption on Cardiometabolic Endpoints
A study testing Commercially-Available Energy Drink in people with Cardiovascular Diseases, run by University of the Pacific at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Commercially-Available Energy Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 30 Jul 2020
- 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
- Healthy adults aged 18 - 40 years
- Participants willing to adhere to study drink schedule (28 days)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of the Pacific
Stockton, California, 95211
About this study
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.
Read the detailed description
The popularity of energy drinks (EDs) have increased over the last few decades due to their purported benefits as mental and physical performance enhancements. While caffeine is a major ingredient in most EDs (ranging from 80 mg to 500 mg per drink), they may also contain various supplements, such as guarana, taurine, ginseng, B vitamins, gluconolactone, yohimbe, carnitine, and bitter orange, as well as high amount of sugar (ranging from 25-50 grams). The United States Food and Drug Administration (FDA) has cited that a daily intake of 400 mg caffeine (approximately 4-5 cups of coffee) in adults is generally safe and not associated with dangerous, negative effects. The Substance Abuse and Mental Health Services Administration reported a doubling of emergency department visits involving EDs from 10,068 visits in 2007 to 20,783 visits in 2011. Commonly reported adverse reactions include insomnia, nervousness, headache, tachycardia, and seizures. Currently, the health effects of long-term ED use remain unknown.
This study is a proof-of-concept, prospective trial that aims to evaluate the effects of chronic ED consumption on cardiometabolic parameters in a healthy population. Subjects will consume two cans (16 oz.) of an energy drink daily for 4 weeks. The study will assess any changes in blood pressure (BP), electrocardiographic (ECG) parameters, blood glucose, cholesterol, weight, body mass index (BMI), and body fat composition before and after consuming EDs for 4 weeks.
- Conditions
- Cardiovascular Diseases
- Being tested
- Commercially-Available Energy Drink
- Keywords
- Energy Drink, Blood Pressure, Arrhythmia
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Commercially-Available Energy drink | Experimental | Healthy volunteers willing to consume two cans of energy drinks (16 oz./can) daily for 4 weeks Receives: Dietary Supplement: Commercially-Available Energy Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 weeks
Secondary outcomes (7)
Change in QTc Interval before and after 1 hour of energy drink consumption
Measuring change in QTc interval via electrocardiogram before and after 1 hour of energy drink consumption
Measured: 1 hour
Change in QTc Interval before and after 4 weeks of energy drink consumption
Measuring change in QTc interval via electrocardiogram before and after 4 weeks of energy drink consumption
Measured: 4 weeks
Change in fasting blood glucose before and after 4 weeks of energy drink consumption
Measuring the change in fasting blood glucose before and after 4 weeks of energy drink consumption
Measured: 4 weeks
Change in fasting lipid panel parameters before and after 4 weeks of energy drink consumption
Measuring the changes in total cholesterol (TC), high-density lipoprotein (HDL), triglyceride (TG), and calculated low-density lipoprotein (LDL-C) levels before and after 4 weeks of energy drink consumption
Measured: 4 weeks
Change in Body Mass Index before and after 4 weeks of energy drink consumption
Measuring the change in Body Mass Index (BMI) before and after 4 weeks of energy drink consumption
Measured: 4 weeks
Change in Body Fat Analysis before and after 4 weeks of energy drink consumption
Measuring the changes in Body Fat Analysis before and after 4 weeks of energy drink consumption, including percentage of body fat, fat mass, muscle mass, and fat in trunk
Measured: 4 weeks
Change in Serum Creatinine before and after 4 weeks of energy drink consumption
Measuring the change in Serum Creatinine before and after 4 weeks of energy drink consumption
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start6 Mar 2019
- Primary completion20 Jun 2019
- Study completion30 Jul 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- May Chen, PharmD, Principal investigator, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840863
- Sponsor's protocol ID
- 19-02
- Status last verified
- Nov 2020
- First submitted
- 11 Jan 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Energy Drink Consumption on Cardiometabolic Endpoints
- ClinicalTrials.gov ID
- NCT03840863
- Acronym / sponsor ID
- 19-02
- Conditions
- Cardiovascular Diseases
- Keywords
- Energy Drink, Blood Pressure, Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 15 Feb 2019 (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.
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.
Detailed description
The popularity of energy drinks (EDs) have increased over the last few decades due to their purported benefits as mental and physical performance enhancements. While caffeine is a major ingredient in most EDs (ranging from 80 mg to 500 mg per drink), they may also contain various supplements, such as guarana, taurine, ginseng, B vitamins, gluconolactone, yohimbe, carnitine, and bitter orange, as well as high amount of sugar (ranging from 25-50 grams). The United States Food and Drug Administration (FDA) has cited that a daily intake of 400 mg caffeine (approximately 4-5 cups of coffee) in adults is generally safe and not associated with dangerous, negative effects. The Substance Abuse and Mental Health Services Administration reported a doubling of emergency department visits involving EDs from 10,068 visits in 2007 to 20,783 visits in 2011. Commonly reported adverse reactions include insomnia, nervousness, headache, tachycardia, and seizures. Currently, the health effects of long-term ED use remain unknown.
This study is a proof-of-concept, prospective trial that aims to evaluate the effects of chronic ED consumption on cardiometabolic parameters in a healthy population. Subjects will consume two cans (16 oz.) of an energy drink daily for 4 weeks. The study will assess any changes in blood pressure (BP), electrocardiographic (ECG) parameters, blood glucose, cholesterol, weight, body mass index (BMI), and body fat composition before and after consuming EDs for 4 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Commercially-Available Energy drink | Experimental | Dietary Supplement: Commercially-Available Energy DrinkHealthy volunteers willing to consume two cans of energy drinks (16 oz./can) daily for 4 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults aged 18 - 40 years
- Participants willing to adhere to study drink schedule (28 days)
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Commercially-Available Energy DrinkParticipant will consume 2 cans of an energy drink (16 oz./can) per day. One in the morning and one in the afternoon. | Dietary supplement | Commercially-Available Energy drink |
Primary outcome
Change in blood pressure before and 1 hour after energy drink consumption
Time frame: 1 hour
Measuring acute changes in peripheral systolic blood pressure before and 1 hour after energy drink consumption
Change in blood pressure before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Measuring chronic changes in peripheral systolic blood pressure before and 4 weeks after energy drink consumption
7 secondary outcomes
Change in QTc Interval before and after 1 hour of energy drink consumption
Time frame: 1 hour
Change in QTc Interval before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Change in fasting blood glucose before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Change in fasting lipid panel parameters before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Change in Body Mass Index before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Change in Body Fat Analysis before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Change in Serum Creatinine before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
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 6 Nov 2020.
- Individual participant dataSharing planned: No
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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.
May Chen, PharmD principal investigator
University of the Pacific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercially-Available Energy Drink in people with Cardiovascular Diseases, run by University of the Pacific 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 2 inclusion and 8 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 6 Nov 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. 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 blood pressure before and 1 hour after energy drink consumption (time frame: 1 hour). The study lists 2 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 6 Nov 2020.