Action of Caffeinated and Decaffeinated Espresso on Autonomic Function

This study has been terminated.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00576030
First received: December 14, 2007
Last updated: July 2, 2010
Last verified: August 2009
  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:

  1. Habitual caffeinated espresso coffee drinkers show an increase in blood pressure, heart rate variability and parasympathetic activity (high frequency band) of the heart.
  2. 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.
  3. 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

Resource links provided by NLM:


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 April 17, 2014