Endothelial FunctionNCT05575895
Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers
An observational study of Endothelial Function, run by National Institute of Cardiology, Laranjeiras, Brazil at 2 sites in Brazil.
Trial summary
Purpose: Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. Their consumption is rising worldwide, with only few conflicting studies examining their vascular effects in young adults. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function
- What is being tested?
- Ingestion of the energy drink (Red Bull®) and Ingestion of mineral water
- How many people
- 22 participants
- Where
- 2 sitesBrazil
- Study dates
- 10 Jan 2020to 30 Jun 2022
- Phase
- Observational
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: healthy male volunteers with no relevant findings in the medical history
Who may be able to join
- healthy male volunteers with no relevant findings in the medical history
Who cannot join
- being a competitive athlete;
- being on regular medication;
- using illicit drugs;
- being allergic to coffee, taurine or any of the components of the selected energy drink; - -
- having a body mass index ≥ 30 kg/m2.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
National Institute of Cardiology, Ministry of Health, Brazil
Rio de Janeiro, 22240-006
Eduardo Tibiriçá
Rio de Janeiro, 22240006
About this study
Purpose: Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. Their consumption is rising worldwide, with only few conflicting studies examining their vascular effects in young adults. We evaluated microvascular reactivity (MR) before and after ED in young healthy male volunteers.
Methods: Systemic MR was evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis before, 90 and 180 minutes after the consumption of one can of ED or the same volume of water (control), followed by postocclusive reactive hyperemia (PORH).
Read the detailed description
Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. These products are marketed as boosters of mental and physical performance and are increasingly used in Western societies. Case reports of adverse effects related to ED consumption have been described in healthy young individuals, including coronary artery vasospasm, and myocardial infarction. These data suggest that endothelial dysfunction (EDysf) plays a role in ED cardiovascular effects and have prompted studies with conflicting results. The present study evaluated the microvascular reactivity (MR) after ingestion of one can of ED compared to a control, in young healthy male volunteers.
- Conditions
- Endothelial Function
- Being tested
- Ingestion of the energy drink (Red Bull®), Ingestion of mineral water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingestion of the energy drink (Red Bull®)Dietary supplement
Ingestion of 250 ml of the energy drink (Red Bull®)
Ingestion of mineral waterDietary supplement
Ingestion of 250 ml of mineral water (Minalba®)
| Study group | Role | What they receive |
|---|---|---|
| Energy Drink | Ingestion of 250 ml of the energy drink (Red Bull®)
- Evaluation of systemic skin microvascular endothelial function Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function. Receives: Dietary Supplement: Ingestion of the energy drink (Red Bull®) | |
| Control | Ingestion of 250 ml of mineral water (Minalba®)
- Evaluation of systemic skin microvascular endothelial function Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function. Receives: Dietary Supplement: Ingestion of mineral water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium-dependent skin microvascular reactivity
Cutaneous microvascular flow measured with laser speckle contrast imaging
Measured: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start10 Jan 2020
- Primary completion10 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575895
- Sponsor's protocol ID
- CAAE 13135219.0.0000.5272
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 14 Oct 2022
- 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 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers
- ClinicalTrials.gov ID
- NCT05575895
- Acronym / sponsor ID
- CAAE 13135219.0.0000.5272
- Conditions
- Endothelial Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Oct 2022 (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.
Purpose: Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. Their consumption is rising worldwide, with only few conflicting studies examining their vascular effects in young adults. We evaluated microvascular reactivity (MR) before and after ED in young healthy male volunteers.
Methods: Systemic MR was evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis before, 90 and 180 minutes after the consumption of one can of ED or the same volume of water (control), followed by postocclusive reactive hyperemia (PORH).
Detailed description
Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. These products are marketed as boosters of mental and physical performance and are increasingly used in Western societies. Case reports of adverse effects related to ED consumption have been described in healthy young individuals, including coronary artery vasospasm, and myocardial infarction. These data suggest that endothelial dysfunction (EDysf) plays a role in ED cardiovascular effects and have prompted studies with conflicting results. The present study evaluated the microvascular reactivity (MR) after ingestion of one can of ED compared to a control, in young healthy male volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy Drink | – | Dietary Supplement: Ingestion of the energy drink (Red Bull®)Ingestion of 250 ml of the energy drink (Red Bull®) - Evaluation of systemic skin microvascular endothelial function Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function. |
| Control | – | Dietary Supplement: Ingestion of mineral waterIngestion of 250 ml of mineral water (Minalba®) - Evaluation of systemic skin microvascular endothelial function Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy male volunteers with no relevant findings in the medical history
Key inclusion criteria (1 listed)
- healthy male volunteers with no relevant findings in the medical history
Key exclusion criteria (5 listed)
- being a competitive athlete;
- being on regular medication;
- using illicit drugs;
- being allergic to coffee, taurine or any of the components of the selected energy drink; - -
- having a body mass index ≥ 30 kg/m2.
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 |
|---|---|---|
| Ingestion of the energy drink (Red Bull®)Ingestion of 250 ml of the energy drink (Red Bull®) | Dietary supplement | Energy Drink |
| Ingestion of mineral waterIngestion of 250 ml of mineral water (Minalba®) | Dietary supplement | Control |
Primary outcome
Endothelium-dependent skin microvascular reactivity
Time frame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
Cutaneous microvascular flow measured with laser speckle contrast imaging
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 14 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Function, run by National Institute of Cardiology, Laranjeiras, Brazil at 2 sites in Brazil.
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 1 inclusion and 5 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Endothelium-dependent skin microvascular reactivity (time frame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.). 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 14 Oct 2022.