Cardiovascular RiskNCT01421979
Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
A study testing Energy Drink, Taurine, Caffeine in people with Cardiovascular Risk, run by University of Hohenheim at 1 site in Germany.
Trial summary
The aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk
- What is being tested?
- Energy Drink, Taurine, Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Aug 2013
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- written informed consent
- healthy (no acute or chronic desease)
- BMI 20,0 - 25,9 kg/m2
- moderate and non-regular consumption of alcohol, EDs and coffee
Who cannot join
- pregnancy
- regular medication (oral contraceptives permitted)
- hypertension and other deseases of the cardiovascular system
- liver-deseases
- psychiatric deseases
- epilepsy
Show all 11Show fewer
- other relevant deseases
- (former) alcoholics
- non-compliance to the study-protocol
- simultaneous participation in another clinical trial
- retraction of the written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health.
- Conditions
- Cardiovascular Risk
- Being tested
- Energy Drink, Taurine, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Drink, Taurine, CaffeineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| exposure under sleep deprivation | Experimental | Examination of the effects of EDs in combination with alcohol consumption and sleep deprivation. Receives: Dietary Supplement: Energy Drink, Taurine, Caffeine |
| Exercise after consumption | Experimental | Examination of the effects of EDs in combination with alcohol consumption and exercise. Receives: Dietary Supplement: Energy Drink, Taurine, Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart-rate-variability (HRV)
Measured: during 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular RiskStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421979
- Sponsor's protocol ID
- ED2011
- Status last verified
- Feb 2015
- First submitted
- 22 Aug 2011
- Last updated
- 5 Feb 2015
- Results posted
- No
Publications
Basrai M, Schweinlin A, Menzel J, Mielke H, Weikert C, Dusemund B, Putze K, Watzl B, Lampen A, Bischoff SC. Energy Drinks Induce Acute Cardiovascular and Metabolic Changes Pointing to Potential Risks for Young Adults: A Randomized Controlled Trial. J Nutr. 2019 Mar 1;149(3):441-450. doi: 10.1093/jn/nxy303.
PubMed 30805607
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
- ClinicalTrials.gov ID
- NCT01421979
- Acronym / sponsor ID
- ED2011
- Conditions
- Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Aug 2011 (estimated)
- 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 aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposure under sleep deprivation | Experimental | Dietary Supplement: Energy Drink, Taurine, CaffeineExamination of the effects of EDs in combination with alcohol consumption and sleep deprivation. |
| Exercise after consumption | Experimental | Dietary Supplement: Energy Drink, Taurine, CaffeineExamination of the effects of EDs in combination with alcohol consumption and exercise. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- written informed consent
- healthy (no acute or chronic desease)
- BMI 20,0 - 25,9 kg/m2
- moderate and non-regular consumption of alcohol, EDs and coffee
Key exclusion criteria (11 listed)
- pregnancy
- regular medication (oral contraceptives permitted)
- hypertension and other deseases of the cardiovascular system
- liver-deseases
- psychiatric deseases
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 Drink, Taurine, Caffeine | Dietary supplement | Exercise after consumption, exposure under sleep deprivation |
Primary outcome
Heart-rate-variability (HRV)
Time frame: during 24 hours
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 5 Feb 2015.
- Derived from this study: PubMed 30805607Basrai M, Schweinlin A, Menzel J, Mielke H, Weikert C, Dusemund B, Putze K, Watzl B, Lampen A, Bischoff SC. Energy Drinks Induce Acute Cardiovascular and Metabolic Changes Pointing to Potential Risks for Young Adults: A Randomized Controlled Trial. J Nutr. 2019 Mar 1;149(3):441-450. doi: 10.1093/jn/nxy303.
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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.
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, Taurine, Caffeine in people with Cardiovascular Risk, run by University of Hohenheim at 1 site in Germany.
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 11 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 5 Feb 2015. 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 Germany. 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?
Heart-rate-variability (HRV) (time frame: during 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01421979, which also lists 1 linked publication.
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 5 Feb 2015.