Action of Caffeinated and Decaffeinated Espresso on Heart Rate Variability, Blood Pressure and Heart Frequency in Young Healthy Individuals - Tabular View

Tracking Information

First Received Date ^ICMJE

December 14, 2007

Last Updated Date

December 17, 2007

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Heart rate variability [ Time Frame: 70 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00576030 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

blood pressure [ Time Frame: 70 min. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Action of Caffeinated and Decaffeinated Espresso on Heart Rate Variability, Blood Pressure and Heart Frequency in Young Healthy Individuals

Official Title ^ICMJE

Brief Summary

More than 80% of the population in the USA consume coffee each day. However there not many studies on change of heart rate variability and placebo effects after consumption of coffee.

In our study we aim to test the following hypotheses:

Habitual caffeinated espresso coffee drinkers show an increase in blood pressure, heart rate variability and parasympathetic activity (high frequency band) of the heart.
Non-habitual caffeinated espresso coffee drinkers show an increase of blood pressure. The heart rate variability and the parasympathetic activity of the heart will decrease.
Caffienated or decaffinated espresso induces comparable changes in habitual or non-habitual coffee drinkers.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Cross-Sectional

Condition ^ICMJE

Influence of Espresso on Heart Rate Variability

Intervention ^ICMJE

Other: hab cof with water
Other: hab cof with dec espresso
Other: hab cof with caf espresso
Other: non-hab cof with water
Other: non-hab cof with dec espresso
Other: non-hab cof with caf espresso

Study Arms / Comparison Groups

habitual coffee drinkers
non-habitual coffee drinkers

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18- 50 years old, healthy

Exclusion Criteria:

Medication, obese(BMI > 30)

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Frank Zimmermann-Viehoff, MD

+49-30-84454046

frank.zimmermann@charite.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00576030

Responsible Party

Prof. Dr. H.-C. Deter, Dept of Psychosomatic Medicine and Psychotherapy, Benjamin Franklin Campus, Charité,Berlin

Study ID Numbers ^ICMJE

EA4/061/06, EA4/061/06

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Charite University, Berlin, Germany

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP