- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01421979
Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
February 4, 2015 updated by: University of Hohenheim
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
-
Stuttgart, Baden-Württemberg, Germany, 70593
- University of Hohenheim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- pregnancy
- regular medication (oral contraceptives permitted)
- hypertension and other deseases of the cardiovascular system
- liver-deseases
- psychiatric deseases
- epilepsy
- other relevant deseases
- (former) alcoholics
- non-compliance to the study-protocol
- simultaneous participation in another clinical trial
- retraction of the written informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exposure under sleep deprivation
Examination of the effects of EDs in combination with alcohol consumption and sleep deprivation.
|
|
Experimental: Exercise after consumption
Examination of the effects of EDs in combination with alcohol consumption and exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart-rate-variability (HRV)
Time Frame: during 24 hours
|
during 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
August 22, 2011
First Submitted That Met QC Criteria
August 22, 2011
First Posted (Estimate)
August 23, 2011
Study Record Updates
Last Update Posted (Estimate)
February 5, 2015
Last Update Submitted That Met QC Criteria
February 4, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ED2011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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