Elucidation and Monitoring Postprandial Endothelial Function (EMPEF)
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| First Received Date ICMJE | October 3, 2008 | ||||||||
| Last Updated Date | September 28, 2009 | ||||||||
| Start Date ICMJE | October 2008 | ||||||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00766623 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Elucidation and Monitoring Postprandial Endothelial Function | ||||||||
| Official Title ICMJE | Elucidation and Monitoring Postprandial Endothelial Function | ||||||||
| Brief Summary | The primary aim of this study is to evaluate the effect of a high fat challenge on several measures of endothelial function. The secondary aim of this study is to elucidate the mechanism of postprandial endothelial dysfunction and to identify early biomarkers |
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| Detailed Description | Endothelial dysfunction (ED) is a hallmark for the initial stage of vascular dysfunction and has been associated with diet-related disorders such as cardiovascular disease. This makes prevention of ED an important health target. From previous studies we know that a high-fat (HF) meal (challenge) impairs postprandial endothelial function (EF). Current studies only evaluated the effect of a HF meal on Flow Mediated Dilatation (FMD), a measure of macro vascular EF. This methodology (FMD) however, is time consuming and large variations in reproducibility are reported in literature. The question remains whether other types of macro- and micro vascular EF measurements can be used to observe ED after a HF meal that are more accurate, faster and easier to perform. In addition, it is know that the postprandial phase results in activation of leukocytes. This activation of leukocytes is likely to contribute to ED, but the exact underling mechanism remains unclear. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
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| Publications * | Esser D, Oosterink E, op 't Roodt J, Henry RM, Stehouwer CD, Müller M, Afman LA. Vascular and inflammatory high fat meal responses in young healthy men; a discriminative role of IL-8 observed in a randomized trial. PLoS One. 2013;8(2):e53474. doi: 10.1371/journal.pone.0053474. Epub 2013 Feb 6. | ||||||||
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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 | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Completion Date | March 2009 | ||||||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: • Allergic to cow milk or dairy products
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| Gender | Male | ||||||||
| Ages | 18 Years to 30 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00766623 | ||||||||
| Other Study ID Numbers ICMJE | NL23651.081.08, empef, abr23651, 08/10 EMPEF | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Wageningen universiteit department of human nutrition, Wageningen universiteit | ||||||||
| Study Sponsor ICMJE | Wageningen University | ||||||||
| Collaborators ICMJE | Top Institute Food and Nutrition | ||||||||
| Investigators ICMJE |
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| Information Provided By | Wageningen University | ||||||||
| Verification Date | September 2009 | ||||||||
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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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