Elucidation and Monitoring Postprandial Endothelial Function

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Endothelial Dysfunction
• Interventions: Dietary Supplement: high fat meal; Dietary Supplement: control meal

• Registration Number: NCT00766623
• Lead Sponsor: Wageningen University

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-28
• Last Update Posted: 2009-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High fat meal	high fat meal	A high fat milkshake containing 95g of fat
Control meal	control meal	Milkshake comparable with a normal breakfast
High fat meal 2	high fat meal	A high fat milkshake containing 95g of fat
High fat meal 3	high fat meal	A high fat milkshake containing 95g of fat
Control meal 2	control meal	Milkshake comparable with a normal breakfast
Control meal 3	control meal	Milkshake comparable with a normal breakfast

Primary Outcome Measures

Name	Time	Method
Macrovascular local arterial stiffness by echo-tracking	0, 3, 6 hours
Macrovascular regional arterial stiffness by tonometry	0, 3, 6 h
Macrovascular circulation by flow mediated dilatation	0, 3, 6h
Microvascular circulation by iontophoresis/laser doppler	0, 3, 6h

Secondary Outcome Measures

Name	Time	Method
PBMC gene expression profiles	0, 1, 2, 3, 5, 6 hours
Leukocyte activation markers	0, 3, 6h
cytokine profiles	0, 1, 2, 3, 5, 6 hours
known plasma markers of ED	0, 1, 2, 3, 5, 6 hours

Trial Locations

Locations (1)

Wageningen universiteit division of human; 🇳🇱 Wageningen, Gelderland, Netherlands