Elucidation and Monitoring Postprandial Endothelial Function

Cardiovascular Disease Clinical Trial

— EMPEF  

Official title:

Elucidation and Monitoring Postprandial Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766623
• Other study ID #: NL23651.081.08
• Secondary ID: empef, abr23651,
• Status: Completed
• Phase: N/A
• First received: October 3, 2008
• Last updated: September 28, 2009
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: September 2009
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Endothelial Dysfunction

Intervention

Dietary Supplement:
• high fat meal
milkshake containing 95g fat
• control meal
milkshake comparable with a normal breakfast

Locations

Country	Name	City	State
Netherlands	Wageningen universiteit division of human	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macrovascular local arterial stiffness by echo-tracking		0, 3, 6 hours	No
Primary	Macrovascular regional arterial stiffness by tonometry		0, 3, 6 h	No
Primary	Macrovascular circulation by flow mediated dilatation		0, 3, 6h	No
Primary	Microvascular circulation by iontophoresis/laser doppler		0, 3, 6h	No
Secondary	PBMC gene expression profiles		0, 1, 2, 3, 5, 6 hours	No
Secondary	Leukocyte activation markers		0, 3, 6h	No
Secondary	cytokine profiles		0, 1, 2, 3, 5, 6 hours	No
Secondary	known plasma markers of ED		0, 1, 2, 3, 5, 6 hours	No