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NCT00766623

Elucidation and Monitoring Postprandial Endothelial Function

NCT ID: NCT00766623

Last Updated: 2009-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Disease Endothelial Dysfunction

Keywords

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endothelium, postprandial microvascular macrovascular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High fat meal

A high fat milkshake containing 95g of fat

Group Type EXPERIMENTAL

high fat meal

Intervention Type DIETARY_SUPPLEMENT

milkshake containing 95g fat

Control meal

Milkshake comparable with a normal breakfast

Group Type EXPERIMENTAL

control meal

Intervention Type DIETARY_SUPPLEMENT

milkshake comparable with a normal breakfast

High fat meal 2

A high fat milkshake containing 95g of fat

Group Type EXPERIMENTAL

high fat meal

Intervention Type DIETARY_SUPPLEMENT

milkshake containing 95g fat

High fat meal 3

A high fat milkshake containing 95g of fat

Group Type EXPERIMENTAL

high fat meal

Intervention Type DIETARY_SUPPLEMENT

milkshake containing 95g fat

Control meal 2

Milkshake comparable with a normal breakfast

Group Type EXPERIMENTAL

control meal

Intervention Type DIETARY_SUPPLEMENT

milkshake comparable with a normal breakfast

Control meal 3

Milkshake comparable with a normal breakfast

Group Type EXPERIMENTAL

control meal

Intervention Type DIETARY_SUPPLEMENT

milkshake comparable with a normal breakfast

Interventions

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high fat meal

milkshake containing 95g fat

Intervention Type DIETARY_SUPPLEMENT

control meal

milkshake comparable with a normal breakfast

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* male, caucasian

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Wageningen universiteit

Principal Investigators

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Michael Müller, Prof.Dr

Role: STUDY_CHAIR

Chair Department of human nutrition NMG group

Lydia A Afman, PhD

Role: STUDY_DIRECTOR

Senior scientist department Human Nutrition Wageningen University

Locations

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Wageningen universiteit division of human

Wageningen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED

PMID: 23405070 (View on PubMed)

Other Identifiers

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empef, abr23651, 08/10 EMPEF

Identifier Type: -

Identifier Source: secondary_id

NL23651.081.08

Identifier Type: -

Identifier Source: org_study_id