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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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Dietary Supplement: Energy Drink, Taurine, Caffeine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : April 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
Drug Information available for: Taurine
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: exposure under sleep deprivation
Examination of the effects of EDs in combination with alcohol consumption and sleep deprivation.
 Dietary Supplement: Energy Drink, Taurine, Caffeine
Experimental: Exercise after consumption
Examination of the effects of EDs in combination with alcohol consumption and exercise.
 Dietary Supplement: Energy Drink, Taurine, Caffeine


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Heart-rate-variability (HRV) [ Time Frame: during 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421979


Locations
Germany
University of Hohenheim
Stuttgart, Baden-Württemberg, Germany, 70593
Sponsors and Collaborators
University of Hohenheim
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT01421979     History of Changes
Other Study ID Numbers: ED2011
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents