Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Hohenheim

ClinicalTrials.gov Identifier:

NCT01421979

First received: August 22, 2011

Last updated: February 4, 2015

Last verified: February 2015

History of Changes

Tracking Information
First Received Date ^ICMJE	August 22, 2011
Last Updated Date	February 4, 2015
Start Date ^ICMJE	April 2011
Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 22, 2011)	Heart-rate-variability (HRV) [ Time Frame: during 24 hours ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01421979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
Official Title ^ICMJE	Not Provided
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Cardiovascular Risk
Intervention ^ICMJE	Dietary Supplement: Energy Drink, Taurine, Caffeine
Study Arm (s)	Experimental: exposure under sleep deprivation Examination of the effects of EDs in combination with alcohol consumption and sleep deprivation. Intervention: Dietary Supplement: Energy Drink, Taurine, Caffeine Experimental: Exercise after consumption Examination of the effects of EDs in combination with alcohol consumption and exercise. Intervention: Dietary Supplement: Energy Drink, Taurine, Caffeine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	38
Completion Date	August 2013
Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 25 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Germany
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01421979
Other Study ID Numbers ^ICMJE	ED2011
Has Data Monitoring Committee	Not Provided
Responsible Party	University of Hohenheim
Study Sponsor ^ICMJE	University of Hohenheim
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Hohenheim
Verification Date	February 2015
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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