Elucidation and Monitoring Postprandial Endothelial Function (EMPEF)

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: high fat meal; Dietary supplement: control meal

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6703HD
      • Wageningen universiteit division of human

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: Top Institute Food and Nutrition
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: October 3, 2008
• First Submitted That Met QC Criteria: October 3, 2008
• First Posted (Estimate): October 6, 2008

Study Record Updates

• Last Update Posted (Estimate): September 29, 2009
• Last Update Submitted That Met QC Criteria: September 28, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: postprandial; microvascular; endothelium,; macrovascular
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: NL23651.081.08; empef, abr23651, 08/10 EMPEF