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

Tracking Information
First Submitted Date ICMJE	August 22, 2011
First Posted Date ICMJE	August 23, 2011
Last Update Posted Date	February 5, 2015
Study Start Date ICMJE	April 2011
Actual 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 ]
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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Cardiovascular Risk
Intervention ICMJE	Dietary Supplement: Energy Drink, Taurine, Caffeine
Study Arms	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
Actual Enrollment ICMJE; (submitted: August 22, 2011)	38
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2013
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 25 Years (Adult)
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Hohenheim
Study Sponsor ICMJE	University of Hohenheim
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	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