NCT04886869

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 6, 2026

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

April 30, 2021

Last Update Submit

March 4, 2026

Conditions

Autonomic Nervous System Imbalance

Outcome Measures

Primary Outcomes (1)

  • Heart rate (HR)

    ECG-based analysis of heart rate (beats per minute)

    2 hours

Secondary Outcomes (1)

  • Periodic repolarization dynamics (PRD)

    2 hours

Study Arms (3)

Coffee

EXPERIMENTAL

Oral consumption of 3 cups of coffee containing 240 mg caffeine

Dietary Supplement: caffeine

Energy drink

EXPERIMENTAL

Oral consumption of 750 mL of a commercial energy drink containing 240 mg caffeine

Dietary Supplement: caffeine

Placebo

PLACEBO COMPARATOR

Oral consumption of 750 mL water

Dietary Supplement: caffeine

Interventions

caffeineDIETARY_SUPPLEMENT

oral consumption

CoffeeEnergy drinkPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy individuals
  • \> 18 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Munich (LMU Klinikum)

Munich, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35266046DERIVED

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 14, 2021

Study Start

April 1, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

March 6, 2026

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)