Action of Caffeinated and Decaffeinated Espresso on Autonomic Function

Influence of Espresso on Heart Rate Variability Clinical Trial

Official title:

Short-term Autonomic Effects of Caffeinated and Decaffeinated Espresso in Young Healthy Individuals

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00576030
• Other study ID #: EA4/061/06
• Secondary ID: EA4/061/06
• Status: Terminated
• Phase: N/A
• First received: December 14, 2007
• Last updated: July 2, 2010
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18- 50 years old, healthy

Exclusion Criteria:

• Medication, obese(BMI > 30)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Influence of Espresso on Heart Rate Variability

Intervention

Other:
• hab cof with water
habitual coffee drinker provided with water
• hab cof with dec espresso
habitual coffee drinkers given decaffeinated espresso
• hab cof with caf espresso
habitual coffee drinkers given caffeinated espresso
• non-hab cof with water
non-habitual coffee drinkers given water
• non-hab cof with dec espresso
non-habitual coffee drinkers given decaffeinated espresso
• non-hab cof with caf espresso
non-habitual coffee drinkers given caffeinated espresso

Locations

Country	Name	City	State
Germany	Department of Psychosomatic Medicine and Psychotherapy, Charité University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability		70 minutes	No
Secondary	blood pressure		70 min.	No