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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

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ClinicalTrials.gov Identifier: NCT01421979
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
University of Hohenheim

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
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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 * 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.

*   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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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