Autonomic Nervous System ImbalanceNCT04886869
Caffeine and the Autonomic Nervous System
A study testing caffeine in people with Autonomic Nervous System Imbalance, run by LMU Klinikum at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Imbalance
- What is being tested?
- caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individuals
- > 18 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Autonomic Nervous System Imbalance
- Being tested
- caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeineDietary supplement
oral consumption
| Study group | Role | What they receive |
|---|---|---|
| Coffee | Experimental | Oral consumption of 3 cups of coffee containing 240 mg caffeine Receives: Dietary Supplement: caffeine |
| Energy drink | Experimental | Oral consumption of 750 mL of a commercial energy drink containing 240 mg caffeine Receives: Dietary Supplement: caffeine |
| Placebo | Placebo comparator | Oral consumption of 750 mL water Receives: Dietary Supplement: caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (HR)
ECG-based analysis of heart rate (beats per minute)
Measured: 2 hours
Secondary outcomes (1)
Periodic repolarization dynamics (PRD)
ECG-based analysis of repolarization instability (deg²)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Apr 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous System ImbalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Stefan Brunner, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886869
- Sponsor's protocol ID
- CaffeineLMU
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schuttler D, Rudi WS, Bauer A, Hamm W, Brunner S. Impact of energy drink versus coffee consumption on periodic repolarization dynamics: an interventional study. Eur J Nutr. 2022 Aug;61(5):2847-2851. doi: 10.1007/s00394-022-02853-8. Epub 2022 Mar 10.
PubMed 35266046
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Caffeine Consumption on Markers of the Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT04886869
- Acronym / sponsor ID
- CaffeineLMU
- Conditions
- Autonomic Nervous System Imbalance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coffee | Experimental | Dietary Supplement: caffeineOral consumption of 3 cups of coffee containing 240 mg caffeine |
| Energy drink | Experimental | Dietary Supplement: caffeineOral consumption of 750 mL of a commercial energy drink containing 240 mg caffeine |
| Placebo | Placebo comparator | Dietary Supplement: caffeineOral consumption of 750 mL water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy individuals
- > 18 years
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caffeineoral consumption | Dietary supplement | Coffee, Energy drink, Placebo |
Primary outcome
Heart rate (HR)
Time frame: 2 hours
ECG-based analysis of heart rate (beats per minute)
1 secondary outcome
Periodic repolarization dynamics (PRD)
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 35266046Schuttler D, Rudi WS, Bauer A, Hamm W, Brunner S. Impact of energy drink versus coffee consumption on periodic repolarization dynamics: an interventional study. Eur J Nutr. 2022 Aug;61(5):2847-2851. doi: 10.1007/s00394-022-02853-8. Epub 2022 Mar 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine in people with Autonomic Nervous System Imbalance, run by LMU Klinikum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (HR) (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.