Action of Caffeinated and Decaffeinated Espresso on Autonomic Function - Full Text View

Sponsor:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00576030

Purpose

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.
Caffeinated or decaffeinated espresso induces comparable changes in habitual or non-habitual coffee drinkers.

Condition	Intervention
Influence of Espresso on Heart Rate Variability	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
Official Title:	Short-term Autonomic Effects of Caffeinated and Decaffeinated Espresso in Young Healthy Individuals

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	77
Study Start Date:	January 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
H habitual coffee drinkers	Other: hab cof with water habitual coffee drinker provided with water Other: hab cof with dec espresso habitual coffee drinkers given decaffeinated espresso Other: hab cof with caf espresso habitual coffee drinkers given caffeinated espresso
N non-habitual coffee drinkers	Other: non-hab cof with water non-habitual coffee drinkers given water Other: non-hab cof with dec espresso non-habitual coffee drinkers given decaffeinated espresso Other: non-hab cof with caf espresso non-habitual coffee drinkers given caffeinated espresso

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18- 50 years old, healthy

Exclusion Criteria:

Medication, obese(BMI > 30)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576030

Locations

Germany
Department of Psychosomatic Medicine and Psychotherapy, Charité University
Berlin, Germany

Sponsors and Collaborators

Charite University, Berlin, Germany

More Information

No publications provided

Responsible Party:	Prof. Dr. H.-C. Deter, Dept of Psychosomatic Medicine and Psychotherapy, Benjamin Franklin Campus, Charité,Berlin
ClinicalTrials.gov Identifier:	NCT00576030 History of Changes
Other Study ID Numbers:	EA4/061/06, EA4/061/06
Study First Received:	December 14, 2007
Last Updated:	July 2, 2010
Health Authority:	Germany: Ethics Commission

ClinicalTrials.gov processed this record on February 12, 2012