Elucidation and Monitoring Postprandial Endothelial Function (EMPEF)
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Purpose
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 |
|---|---|
|
Cardiovascular Disease Endothelial Dysfunction |
Dietary Supplement: high fat meal Dietary Supplement: control meal |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Elucidation and Monitoring Postprandial Endothelial Function |
- Macrovascular local arterial stiffness by echo-tracking [ Time Frame: 0, 3, 6 hours ] [ Designated as safety issue: No ]
- Macrovascular regional arterial stiffness by tonometry [ Time Frame: 0, 3, 6 h ] [ Designated as safety issue: No ]
- Macrovascular circulation by flow mediated dilatation [ Time Frame: 0, 3, 6h ] [ Designated as safety issue: No ]
- Microvascular circulation by iontophoresis/laser doppler [ Time Frame: 0, 3, 6h ] [ Designated as safety issue: No ]
- PBMC gene expression profiles [ Time Frame: 0, 1, 2, 3, 5, 6 hours ] [ Designated as safety issue: No ]
- Leukocyte activation markers [ Time Frame: 0, 3, 6h ] [ Designated as safety issue: No ]
- cytokine profiles [ Time Frame: 0, 1, 2, 3, 5, 6 hours ] [ Designated as safety issue: No ]
- known plasma markers of ED [ Time Frame: 0, 1, 2, 3, 5, 6 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: High fat meal
A high fat milkshake containing 95g of fat
|
Dietary Supplement: high fat meal
milkshake containing 95g fat
|
|
Experimental: Control meal
Milkshake comparable with a normal breakfast
|
Dietary Supplement: control meal
milkshake comparable with a normal breakfast
|
|
Experimental: High fat meal 2
A high fat milkshake containing 95g of fat
|
Dietary Supplement: high fat meal
milkshake containing 95g fat
|
|
Experimental: High fat meal 3
A high fat milkshake containing 95g of fat
|
Dietary Supplement: high fat meal
milkshake containing 95g fat
|
|
Experimental: Control meal 2
Milkshake comparable with a normal breakfast
|
Dietary Supplement: control meal
milkshake comparable with a normal breakfast
|
|
Experimental: Control meal 3
Milkshake comparable with a normal breakfast
|
Dietary Supplement: control meal
milkshake comparable with a normal breakfast
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- male, caucasian
Exclusion Criteria: • Allergic to cow milk or dairy products
- Body mass index (BMI) < 18 or > 25 kg/m2
- Urine glucose concentrations outside normal ranges (>0,25 g/l)
- Fasting blood glucose outside the normal range (3 - 5.5 mmol/L)
- Tobacco smoking
- Taking medication or food supplements.
- Received inoculations within 2 months of starting the study or planned to during the study
- Donated or intended to donate blood from 2 months before the study till two months after the study
- Blood Hb values below 8.4 mmol/L
- Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)
- High blood pressure (systolic BP> 140 mmHg and/or diastolic BP>90 mmHg)
Contacts and Locations| Netherlands | |
| Wageningen universiteit division of human | |
| Wageningen, Gelderland, Netherlands, 6703HD | |
| 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 |
More Information
No publications provided by Wageningen University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wageningen universiteit department of human nutrition, Wageningen universiteit |
| ClinicalTrials.gov Identifier: | NCT00766623 History of Changes |
| Other Study ID Numbers: | NL23651.081.08, empef, abr23651, 08/10 EMPEF |
| Study First Received: | October 3, 2008 |
| Last Updated: | September 28, 2009 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Wageningen University:
|
endothelium, postprandial microvascular macrovascular |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013