Action of Caffeinated and Decaffeinated Espresso on Autonomic Function
July 2, 2010 updated by: Charite University, Berlin, Germany
Short-term Autonomic Effects of Caffeinated and Decaffeinated Espresso in Young Healthy Individuals
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.
Study Overview
Status
Terminated
Study Type
Interventional
Enrollment (Anticipated)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany
- Department of Psychosomatic Medicine and Psychotherapy, Charité University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18- 50 years old, healthy
Exclusion Criteria:
- Medication, obese(BMI > 30)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: H
habitual coffee drinkers
|
habitual coffee drinker provided with water
habitual coffee drinkers given decaffeinated espresso
habitual coffee drinkers given caffeinated espresso
|
|
Other: N
non-habitual coffee drinkers
|
non-habitual coffee drinkers given water
non-habitual coffee drinkers given decaffeinated espresso
non-habitual coffee drinkers given caffeinated espresso
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Heart rate variability
Time Frame: 70 minutes
|
70 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
blood pressure
Time Frame: 70 min.
|
70 min.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 17, 2007
First Posted (Estimate)
December 18, 2007
Study Record Updates
Last Update Posted (Estimate)
July 5, 2010
Last Update Submitted That Met QC Criteria
July 2, 2010
Last Verified
August 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- EA4/061/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.