Caffeine and the Autonomic Nervous System

NCT ID: NCT04886869

Last Updated: 2021-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autonomic Nervous System Imbalance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Coffee

Oral consumption of 3 cups of coffee containing 240 mg caffeine

Group Type EXPERIMENTAL

caffeine

Intervention Type DIETARY_SUPPLEMENT

oral consumption

Energy drink

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

Group Type EXPERIMENTAL

caffeine

Intervention Type DIETARY_SUPPLEMENT

oral consumption

Placebo

Oral consumption of 750 mL water

Group Type PLACEBO_COMPARATOR

caffeine

Intervention Type DIETARY_SUPPLEMENT

oral consumption

Interventions

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caffeine

oral consumption

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LMU Klinikum

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Stefan Brunner

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Munich (LMU Klinikum)

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Brunner, MD

Role: CONTACT

+49 89 4400 0

Facility Contacts

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Stefan Brunner, MD

Role: primary

+49 89 44000

References

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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.

Reference Type DERIVED
PMID: 35266046 (View on PubMed)

Other Identifiers

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CaffeineLMU

Identifier Type: -

Identifier Source: org_study_id

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