EDUCATE-Study: Energy-Drinks – Unexplored Cardiovascular Alterations in TEens and TwEens

Not Applicable

• Conditions: Healthy subjects; I51.6; Cardiovascular disease, unspecified

• Registration Number: DRKS00027580
• Lead Sponsor: German Heart Foundation / German Foundation of Heart Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-10-31
• Study Start: 2022-01-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Prior written informed consent; healthy children and teenagers between the ages of 10 to 18 years

Exclusion Criteria

Presence of chronic conditions (e.g. congenital heart disease, arterial hypertension, presence of severe dysrhythmia),
history of sudden heart death within the family,
known allergies against beverage ingredients,
regular use of medication with effects on the cardiovascular system, regular use of drugs including smoking and alcohol consumption,
pregnancy.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure, diastolic blood pressure, heart rate, QTc, number of supraventricular (SVES) and ventricular extrasystoles (VES). Primary end points are evaluated at baseline as well as 30, 60, 120 and 240 minutes after the beverage consumption on each study day.

Secondary Outcome Measures

Name	Time	Method
The following parameters are evaluated at baseline as well as 30, 60, 120,240 minutes after the beverage consumption on each study day. Pulse wave velocity, augmentation index, central blood pressure; strain, strain rate, arterial distensibilty of both common carotid arteries; left ventricular strain, EDV, ESV, SV, EF, Ea, Ees(sb), Epot, SW, PVA, Ea/Ees(sb), CW, WE, CE; right ventricular strain. <br>Moreover, a 24-hour blood pressure profile is gathered on both study days. <br><br><br>