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NCT01421979 Clinical Trial

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

Cardiovascular Risk Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01421979
Other study ID # ED2011
Secondary ID
Status Completed
Phase N/A
First received August 22, 2011
Last updated February 4, 2015
Start date April 2011
Est. completion date August 2013

Study information
Verified date February 2015
Source University of Hohenheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Energy Drink, Taurine, Caffeine

Locations
Country Name City State
Germany University of Hohenheim Stuttgart Baden-Württemberg

Sponsors (1)
Lead Sponsor Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Heart-rate-variability (HRV) during 24 hours Yes
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