Vascular FunctionNCT03324256
Energy Drinks and Vascular Function
A study testing energy drink, caffeinated drink and Energy gum in people with Vascular Function, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Function
- What is being tested?
- energy drink, caffeinated drink and Energy gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2018to 16 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being Male
- 18-30 years of age
- No indication of major clinical disease (e.g. diabetes, hypertension, significant arrhythmias, syncope and cardiovascular disease)
- BMI ≤ 30 kg/m^2 and blood pressure ≤ 140/90 mmHg
- Consumption of <400mg of caffeine/day
- Prior history of consumption of energy drinks
Who cannot join
- Being female
- Age <18 or >30 years
- BMI> 30 kg/m^2 and blood pressure > 140/90 mmHg
- Use of medication that may affect vascular measures
- Use of tobacco products including smoking
- Vegan or vegetarian diet
Show all 9Show fewer
- Being energy drink or caffeine naïve or consumption of >400 mg of caffeine/day
- Consumption of >1 energy drinks per month
- Being a shift worker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Energy Drinks on Vascular Function
The purpose of this study will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males.
Read the detailed description
The use of energy products has significantly increased in the last few years and is especially high among young men. The present study will compare the acute effect of a commercially available energy drink, energy gum, coffee and control beverage on endothelial function, arterial stiffness and circulating markers of thrombosis, inflammation and oxidative stress.
- Conditions
- Vascular Function
- Being tested
- energy drink, caffeinated drink, Energy gum, placebo gum, Control drink
- Keywords
- Energy drink consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
energy drinkOther
16 oz cold commercially-available energy drink
caffeinated drinkOther
16oz cold commercially-available caffeinated drink
Energy gumOther
2 pieces of commercially-available energy gum
placebo gumOther
2 pieces of commercially-available placebo gum
Control drinkOther
16oz cold control drink
Total sleep deprivationOther
24-hour total sleep deprivation prior to consumption of energy drink and placebo gum
| Study group | Role | What they receive |
|---|---|---|
| Energy drink and placebo gum | Active comparator | Commercially-available energy drink (16oz) + 2 pieces of placebo gum Receives: Other: energy drink; Other: placebo gum |
| Caffeinated drink and placebo gum | Active comparator | Commercially-available caffeinated drink (16oz) + 2 pieces of placebo gum Receives: Other: caffeinated drink; Other: placebo gum |
| Control drink and energy gum | Active comparator | Control drink (16oz) + 2 pieces of energy gum Receives: Other: Energy gum; Other: Control drink |
| Control drink and placebo gum | Placebo comparator | Control drink (16oz) + 2 pieces of placebo gum Receives: Other: placebo gum; Other: Control drink |
| Energy drink and total sleep deprivation | Active comparator | Commercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation Receives: Other: energy drink; Other: placebo gum; Other: Total sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function
Brachial artery flow-mediated dilation
Measured: Before and 1 and 2 hrs following consumption of drink and gum
Secondary outcomes (6)
Change in arterial stiffness
Carotid to femoral pulse wave velocity
Measured: Before and 1 and 2 hrs following consumption of drink and gum
Change in wave reflection
Augmentation index
Measured: Before and 1 and 2 hrs following consumption of drink and gum
Change in peripheral and central blood pressures
Brachial and aortic blood pressures
Measured: Before and 1 and 2 hrs following consumption of drink and gum
Change in thrombosis and platelet function
Thromboelastograph and platelet aggregation tests
Measured: Before and 1 and 2 hrs following consumption of drink and gum
Change in circulating factors related to vascular function
Circulating levels of Trimethylamine N-oxide (TMAO) and markers of oxidative stress and inflammation
Measured: Before and 1 and 2 hrs following consumption of drink and gum
Change in heart rhythm
Electrocardiogram
Measured: Before and 1 and 2 hrs following consumption of drink and gum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start12 Jan 2018
- Primary completion16 May 2019
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular FunctionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demetra Christou, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324256
- Sponsor's protocol ID
- IRB201700678
- Status last verified
- May 2019
- First submitted
- 20 Oct 2017
- Last updated
- 20 May 2019
- 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 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Energy Drinks on Vascular Function
- ClinicalTrials.gov ID
- NCT03324256
- Acronym / sponsor ID
- IRB201700678
- Conditions
- Vascular Function
- Keywords
- Energy drink consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 27 Oct 2017 (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 will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males.
Detailed description
The use of energy products has significantly increased in the last few years and is especially high among young men. The present study will compare the acute effect of a commercially available energy drink, energy gum, coffee and control beverage on endothelial function, arterial stiffness and circulating markers of thrombosis, inflammation and oxidative stress.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Energy drink and placebo gum | Active comparator | Other: energy drink, Other: placebo gumCommercially-available energy drink (16oz) + 2 pieces of placebo gum |
| Caffeinated drink and placebo gum | Active comparator | Other: caffeinated drink, Other: placebo gumCommercially-available caffeinated drink (16oz) + 2 pieces of placebo gum |
| Control drink and energy gum | Active comparator | Other: Energy gum, Other: Control drinkControl drink (16oz) + 2 pieces of energy gum |
| Control drink and placebo gum | Placebo comparator | Other: placebo gum, Other: Control drinkControl drink (16oz) + 2 pieces of placebo gum |
| Energy drink and total sleep deprivation | Active comparator | Other: energy drink, Other: placebo gum, Other: Total sleep deprivationCommercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being Male
- 18-30 years of age
- No indication of major clinical disease (e.g. diabetes, hypertension, significant arrhythmias, syncope and cardiovascular disease)
- BMI ≤ 30 kg/m^2 and blood pressure ≤ 140/90 mmHg
- Consumption of <400mg of caffeine/day
Key exclusion criteria (9 listed)
- Being female
- Age <18 or >30 years
- BMI> 30 kg/m^2 and blood pressure > 140/90 mmHg
- Use of medication that may affect vascular measures
- Use of tobacco products including smoking
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 drink16 oz cold commercially-available energy drink | Other | Energy drink and placebo gum, Energy drink and total sleep deprivation |
| caffeinated drink16oz cold commercially-available caffeinated drink | Other | Caffeinated drink and placebo gum |
| Energy gum2 pieces of commercially-available energy gum | Other | Control drink and energy gum |
| placebo gum2 pieces of commercially-available placebo gum | Other | Caffeinated drink and placebo gum, Control drink and placebo gum, Energy drink and placebo gum, Energy drink and total sleep deprivation |
| Control drink16oz cold control drink | Other | Control drink and energy gum, Control drink and placebo gum |
| Total sleep deprivation24-hour total sleep deprivation prior to consumption of energy drink and placebo gum | Other | Energy drink and total sleep deprivation |
Primary outcome
Change in endothelial function
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Brachial artery flow-mediated dilation
6 secondary outcomes
Change in arterial stiffness
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Change in wave reflection
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Change in peripheral and central blood pressures
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Change in thrombosis and platelet function
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Change in circulating factors related to vascular function
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Change in heart rhythm
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
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 20 May 2019.
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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.
Demetra Christou, PhD principal investigator
University of Florida
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, caffeinated drink and Energy gum in people with Vascular Function, run by University of Florida 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 6 inclusion and 9 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 20 May 2019. 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 endothelial function (time frame: Before and 1 and 2 hrs following consumption of drink and gum). 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 20 May 2019.