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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 is currently recruiting participants.
Verified August 2011 by University of Hohenheim
Sponsor:
Information provided by (Responsible Party):
University of Hohenheim
ClinicalTrials.gov Identifier:
NCT01421979
First received: August 22, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

Drug Information available for: Taurine
U.S. FDA Resources

Further study details as provided by University of Hohenheim:

Primary Outcome Measures:
  • Heart-rate-variability (HRV) [ Time Frame: during 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
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

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421979

Locations
Germany
University of Hohenheim Recruiting
Stuttgart, Baden-Württemberg, Germany, 70593
Contact: Maryam Basrai     +49 711 451017702        
Sponsors and Collaborators
University of Hohenheim
  More Information

No publications provided

Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT01421979     History of Changes
Other Study ID Numbers: ED2011
Study First Received: August 22, 2011
Last Updated: August 22, 2011
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

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

ClinicalTrials.gov processed this record on May 19, 2013