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Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
This study has been completed.
Sponsor:
University of Hohenheim
Information provided by (Responsible Party):
University of Hohenheim
ClinicalTrials.gov Identifier:
NCT01421979
First received: August 22, 2011
Last updated: February 4, 2015
Last verified: February 2015
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | August 22, 2011 | ||
| Last Updated Date | February 4, 2015 | ||
| Start Date ICMJE | April 2011 | ||
| Primary Completion Date | August 2013 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Heart-rate-variability (HRV) [ Time Frame: during 24 hours ] | ||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | Complete list of historical versions of study NCT01421979 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans | ||
| Official Title ICMJE | Not Provided | ||
| Brief Summary | 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 | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Not Provided | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Cardiovascular Risk | ||
| Intervention ICMJE | Dietary Supplement: Energy Drink, Taurine, Caffeine | ||
| Study Arms |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 38 | ||
| Completion Date | August 2013 | ||
| Primary Completion Date | August 2013 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 25 Years (Adult) | ||
| Accepts Healthy Volunteers | Yes | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Germany | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01421979 | ||
| Other Study ID Numbers ICMJE | ED2011 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| Plan to Share Data | Not Provided | ||
| IPD Description | Not Provided | ||
| Responsible Party | University of Hohenheim | ||
| Study Sponsor ICMJE | University of Hohenheim | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | University of Hohenheim | ||
| Verification Date | February 2015 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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