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 (Adult)
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


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

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

ClinicalTrials.gov processed this record on September 27, 2016

To Top