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Elucidation and Monitoring Postprandial Endothelial Function

Elucidation and Monitoring Postprandial Endothelial Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00766623
Acronym
EMPEF
Enrollment
20
Registered
2008-10-06
Start date
2008-10-31
Completion date
2009-03-31
Last updated
2009-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Endothelial Dysfunction

Keywords

endothelium,, postprandial, microvascular, macrovascular

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.

Interventions

DIETARY_SUPPLEMENThigh fat meal

milkshake containing 95g fat

DIETARY_SUPPLEMENTcontrol meal

milkshake comparable with a normal breakfast

Sponsors

Top Institute Food and Nutrition
CollaboratorOTHER
Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
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)

Design outcomes

Primary

MeasureTime frame
Microvascular circulation by iontophoresis/laser doppler0, 3, 6h
Macrovascular local arterial stiffness by echo-tracking0, 3, 6 hours
Macrovascular regional arterial stiffness by tonometry0, 3, 6 h
Macrovascular circulation by flow mediated dilatation0, 3, 6h

Secondary

MeasureTime frame
PBMC gene expression profiles0, 1, 2, 3, 5, 6 hours
Leukocyte activation markers0, 3, 6h
cytokine profiles0, 1, 2, 3, 5, 6 hours
known plasma markers of ED0, 1, 2, 3, 5, 6 hours

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026