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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421979
First Posted: August 23, 2011
Last Update Posted: February 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Hohenheim
  Purpose
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 Intervention
Cardiovascular Risk Dietary Supplement: Energy Drink, Taurine, Caffeine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Hohenheim:

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

Enrollment: 38
Study Start Date: April 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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

Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT01421979     History of Changes
Other Study ID Numbers: ED2011
First Submitted: August 22, 2011
First Posted: August 23, 2011
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