Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 22, 2011
February 4, 2015
April 2011
August 2013   (final data collection date for primary outcome measure)
Heart-rate-variability (HRV) [ Time Frame: during 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01421979 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiovascular Risk
Dietary Supplement: Energy Drink, Taurine, Caffeine
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01421979
ED2011
Not Provided
University of Hohenheim
University of Hohenheim
Not Provided
Not Provided
University of Hohenheim
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP