- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04886869
Caffeine and the Autonomic Nervous System
March 4, 2026 updated by: Prof. Dr. Stefan Brunner, LMU Klinikum
Impact of Caffeine Consumption on Markers of the Autonomic Nervous System
Caffeine consumption has been linked to dysfunction of the autonomic nervous system.
In this study the investigators analyze the effects of caffeine containing drinks (including energy drinks and coffee) on ECG based parameters of the autonomic nervous system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
-
Munich, Germany
- University Hospital Munich (LMU Klinikum)
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy individuals
- > 18 years
Exclusion Criteria:
- known cardiovascular disease
- other diseases which may influence the autonomic nervous system
- medication which may influence the autonomic nervous system
- prior caffeine consumption (<24 hours)
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: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coffee
Oral consumption of 3 cups of coffee containing 240 mg caffeine
|
oral consumption
|
|
Experimental: Energy drink
Oral consumption of 750 mL of a commercial energy drink containing 240 mg caffeine
|
oral consumption
|
|
Placebo Comparator: Placebo
Oral consumption of 750 mL water
|
oral consumption
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate (HR)
Time Frame: 2 hours
|
ECG-based analysis of heart rate (beats per minute)
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Periodic repolarization dynamics (PRD)
Time Frame: 2 hours
|
ECG-based analysis of repolarization instability (deg²)
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)
April 1, 2021
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
April 30, 2021
First Submitted That Met QC Criteria
May 10, 2021
First Posted (Actual)
May 14, 2021
Study Record Updates
Last Update Posted (Actual)
March 6, 2026
Last Update Submitted That Met QC Criteria
March 4, 2026
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CaffeineLMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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