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Sponsors and Collaborators: |
Wageningen University TI Food and Nutrition |
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Information provided by: | Wageningen University |
ClinicalTrials.gov Identifier: | NCT00766623 |
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
Condition | Intervention |
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Cardiovascular Disease Endothelial Dysfunction |
Dietary Supplement: high fat meal Dietary Supplement: control meal |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment |
Official Title: | Elucidation and Monitoring Postprandial Endothelial Function |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
High fat meal: Experimental
A high fat milkshake containing 95g of fat
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Dietary Supplement: high fat meal
milkshake containing 95g fat
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Control meal: Experimental
Milkshake comparable with a normal breakfast
|
Dietary Supplement: control meal
milkshake comparable with a normal breakfast
|
High fat meal 2: Experimental
A high fat milkshake containing 95g of fat
|
Dietary Supplement: high fat meal
milkshake containing 95g fat
|
High fat meal 3: Experimental
A high fat milkshake containing 95g of fat
|
Dietary Supplement: high fat meal
milkshake containing 95g fat
|
Control meal 2: Experimental
Milkshake comparable with a normal breakfast
|
Dietary Supplement: control meal
milkshake comparable with a normal breakfast
|
Control meal 3: Experimental
Milkshake comparable with a normal breakfast
|
Dietary Supplement: control meal
milkshake comparable with a normal breakfast
|
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.
Ages Eligible for Study: | 18 Years to 30 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria: • Allergic to cow milk or dairy products
Contact: Diederik Esser, Msc | 0031317480405 | diederik.esser@wur.nl |
Contact: Lydia A Afman, PhD | 0031317483342 | lydia.afman@wur.nl |
Netherlands, Gelderland | |
Wageningen universiteit division of human | Recruiting |
Wageningen, Gelderland, Netherlands, 6703HD | |
Contact: Diederik Esser, Msc 0031317480405 diederik.esser@wur.nl | |
Principal Investigator: Diederik esser, Msc |
Study Chair: | Michael Müller, Prof.Dr | Chair Department of human nutrition NMG group |
Study Director: | Lydia A Afman, PhD | Senior scientist department Human Nutrition Wageningen University |
Responsible Party: | Wageningen universiteit ( Wageningen universiteit department of human nutrition ) |
Study ID Numbers: | NL23651.081.08, empef, abr23651, 08/10 EMPEF |
Study First Received: | October 3, 2008 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00766623 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
endothelium, postprandial microvascular macrovascular |
Cardiovascular Diseases |