Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
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ClinicalTrials.gov Identifier: NCT01421979 |
Recruitment Status :
Completed
First Posted : August 23, 2011
Last Update Posted : February 5, 2015
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Sponsor:
University of Hohenheim
Information provided by (Responsible Party):
University of Hohenheim
Tracking Information | |||
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First Submitted Date ICMJE | August 22, 2011 | ||
First Posted Date ICMJE | August 23, 2011 | ||
Last Update Posted Date | February 5, 2015 | ||
Study Start Date ICMJE | April 2011 | ||
Actual 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 | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | 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 ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (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 ICMJE |
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Publications * | 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. | ||
* 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 | ||
Actual Enrollment ICMJE |
38 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | August 2013 | ||
Actual 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 ICMJE |
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Ages ICMJE | 18 Years to 25 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | 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 | ||
IPD Sharing Statement ICMJE | 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 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |