Elucidation and Monitoring Postprandial Endothelial Function - Full Text View

Sponsors and Collaborators:	Wageningen University TI Food and Nutrition
Information provided by:	Wageningen University
ClinicalTrials.gov Identifier:	NCT00766623

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

MedlinePlus related topics: Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment
Official Title:	Elucidation and Monitoring Postprandial Endothelial Function

Further study details as provided by Wageningen University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
High fat meal: Experimental A high fat milkshake containing 95g of fat	Dietary Supplement: high fat meal milkshake containing 95g fat
Control meal: Experimental Milkshake comparable with a normal breakfast	Dietary Supplement: control meal milkshake comparable with a normal breakfast
High fat meal 2: Experimental A high fat milkshake containing 95g of fat	Dietary Supplement: high fat meal milkshake containing 95g fat
High fat meal 3: Experimental A high fat milkshake containing 95g of fat	Dietary Supplement: high fat meal milkshake containing 95g fat
Control meal 2: Experimental Milkshake comparable with a normal breakfast	Dietary Supplement: control meal milkshake comparable with a normal breakfast
Control meal 3: Experimental 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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766623

Contacts

Contact: Diederik Esser, Msc	0031317480405	diederik.esser@wur.nl
Contact: Lydia A Afman, PhD	0031317483342	lydia.afman@wur.nl

Locations

Netherlands, Gelderland
Wageningen universiteit division of human	Recruiting
Wageningen, Gelderland, Netherlands, 6703HD
Contact: Diederik Esser, Msc 0031317480405 diederik.esser@wur.nl
Principal Investigator: Diederik esser, Msc

Sponsors and Collaborators

Wageningen University

TI 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

More Information

Responsible Party:	Wageningen universiteit ( Wageningen universiteit department of human nutrition )
Study ID Numbers:	NL23651.081.08, empef, abr23651, 08/10 EMPEF
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766623
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 January 16, 2009