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Elucidation and Monitoring Postprandial Endothelial Function (EMPEF)

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00766623
First received: October 3, 2008
Last updated: September 28, 2009
Last verified: September 2009

October 3, 2008
September 28, 2009
October 2008
February 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00766623 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Elucidation and Monitoring Postprandial Endothelial Function
Elucidation and Monitoring Postprandial Endothelial Function

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
  • Cardiovascular Disease
  • Endothelial Dysfunction
  • Dietary Supplement: high fat meal
    milkshake containing 95g fat
  • Dietary Supplement: control meal
    milkshake comparable with a normal breakfast
  • Experimental: High fat meal
    A high fat milkshake containing 95g of fat
    Intervention: Dietary Supplement: high fat meal
  • Experimental: Control meal
    Milkshake comparable with a normal breakfast
    Intervention: Dietary Supplement: control meal
  • Experimental: High fat meal 2
    A high fat milkshake containing 95g of fat
    Intervention: Dietary Supplement: high fat meal
  • Experimental: High fat meal 3
    A high fat milkshake containing 95g of fat
    Intervention: Dietary Supplement: high fat meal
  • Experimental: Control meal 2
    Milkshake comparable with a normal breakfast
    Intervention: Dietary Supplement: control meal
  • Experimental: Control meal 3
    Milkshake comparable with a normal breakfast
    Intervention: Dietary Supplement: control meal
Esser D, Oosterink E, op 't Roodt J, Henry RM, Stehouwer CD, Müller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2009
February 2009   (final data collection date for primary outcome measure)

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)
Male
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00766623
NL23651.081.08, empef, abr23651, 08/10 EMPEF
No
Wageningen universiteit department of human nutrition, Wageningen universiteit
Wageningen University
Top Institute Food and Nutrition
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
Wageningen University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP