We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

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

Study Description
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
Cardiovascular Risk Dietary Supplement: Energy Drink, Taurine, Caffeine

Study Design

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
Primary Completion Date : August 2013
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

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

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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