Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans

NCT ID: NCT01421979

Last Updated: 2015-02-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-08-31

Brief Summary

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The aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health.

Detailed Description

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Conditions

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Cardiovascular Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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exposure under sleep deprivation

Examination of the effects of EDs in combination with alcohol consumption and sleep deprivation.

Group Type EXPERIMENTAL

Energy Drink, Taurine, Caffeine

Intervention Type DIETARY_SUPPLEMENT

Exercise after consumption

Examination of the effects of EDs in combination with alcohol consumption and exercise.

Group Type EXPERIMENTAL

Energy Drink, Taurine, Caffeine

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Energy Drink, Taurine, Caffeine

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* written informed consent
* healthy (no acute or chronic desease)
* BMI 20,0 - 25,9 kg/m2
* moderate and non-regular consumption of alcohol, EDs and coffee

Exclusion Criteria

* pregnancy
* regular medication (oral contraceptives permitted)
* hypertension and other deseases of the cardiovascular system
* liver-deseases
* psychiatric deseases
* epilepsy
* other relevant deseases
* (former) alcoholics
* non-compliance to the study-protocol
* simultaneous participation in another clinical trial
* retraction of the written informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Hohenheim

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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Basrai M, Schweinlin A, Menzel J, Mielke H, Weikert C, Dusemund B, Putze K, Watzl B, Lampen A, Bischoff SC. Energy Drinks Induce Acute Cardiovascular and Metabolic Changes Pointing to Potential Risks for Young Adults: A Randomized Controlled Trial. J Nutr. 2019 Mar 1;149(3):441-450. doi: 10.1093/jn/nxy303.

Reference Type DERIVED
PMID: 30805607 (View on PubMed)

Other Identifiers

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ED2011

Identifier Type: -

Identifier Source: org_study_id

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