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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:
Information provided by (Responsible Party):
University of Hohenheim
ClinicalTrials.gov Identifier:
NCT01421979
First received: August 22, 2011
Last updated: February 4, 2015
Last verified: February 2015
History of Changes
  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:

MedlinePlus related topics: Caffeine
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 ]
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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421979

Locations
Germany
University of Hohenheim
Stuttgart, Baden-Württemberg, Germany, 70593
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: February 4, 2015
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

ClinicalTrials.gov processed this record on March 03, 2015