Clinical trial NCT00766623: Elucidation and Monitoring Postprandial Endothelial Function
Official title: Elucidation and Monitoring Postprandial Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Endothelial Dysfunction
Keywords: endothelium,
postprandial
microvascular
macrovascular
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2008-10-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

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 criteria: 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)

Primary outcomes:
measure: Macrovascular local arterial stiffness by echo-tracking
timeFrame: 0, 3, 6 hours
measure: Macrovascular regional arterial stiffness by tonometry
timeFrame: 0, 3, 6 h
measure: Macrovascular circulation by flow mediated dilatation
timeFrame: 0, 3, 6h
measure: Microvascular circulation by iontophoresis/laser doppler
timeFrame: 0, 3, 6h
Secondary outcomes:
measure: PBMC gene expression profiles
timeFrame: 0, 1, 2, 3, 5, 6 hours
measure: Leukocyte activation markers
timeFrame: 0, 3, 6h
measure: cytokine profiles
timeFrame: 0, 1, 2, 3, 5, 6 hours
measure: known plasma markers of ED
timeFrame: 0, 1, 2, 3, 5, 6 hours
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen universiteit division of human
state: Gelderland
Study officials:
affiliation: Chair Department of human nutrition NMG group
name: Michael Müller, Prof.Dr
role: STUDY_CHAIR
affiliation: Senior scientist department Human Nutrition Wageningen University
name: Lydia A Afman, PhD
role: STUDY_DIRECTOR
References:
citation: Esser D, Oosterink E, op 't Roodt J, Henry RM, Stehouwer CD, Muller 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.