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

• Sponsor: University of Hohenheim (Other)
• Overall Status: Completed
• CT.gov ID: NCT01421979
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 1.4

Study Details

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	Phase
Cardiovascular Risk	Dietary Supplement: Energy Drink, Taurine, Caffeine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

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) [during 24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Hohenheim	Stuttgart	Baden-Württemberg	Germany	70593

Sponsors and Collaborators

• University of Hohenheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Hohenheim
• ClinicalTrials.gov Identifier: NCT01421979
• Other Study ID Numbers: ED2011
• First Posted: Aug 23, 2011
• Last Update Posted: Feb 5, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Caffeine

Study Results

No Results Posted as of Feb 5, 2015