Cardiovascular Risk Clinical Trial
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 25 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | University of Hohenheim | Stuttgart | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
University of Hohenheim |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart-rate-variability (HRV) | during 24 hours | Yes |
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