Healthy subjects I51.6
Conditions
Interventions
Group 1: Healthy children and teenagers consume a body-weight adjusted amount(3mg caffeine/kg of bodyweight) of Energy-Drinks.
Group 2: The amount of administered placebo-drink is matched to the Energ
Sponsors
German Heart Foundation / German Foundation of Heart Research
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Inclusion criteria
Inclusion criteria: Prior written informed consent; healthy children and teenagers between the ages of 10 to 18 years
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. Moreover, a 24-hour blood pressure profile is gathered on both study days. | — |
Countries
Germany
Contacts
Public ContactFelix Sebastian Oberhoffer
Department of Pediatric Cardiology and Intensive Care, Medical Hospital of the University of Munich, Ludwig-Maximilians-University Munich
Outcome results
None listed