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Cardiovascular DiseaseEMPEFNCT00766623

Elucidation and Monitoring Postprandial Endothelial Function

A study testing high fat meal in people with Cardiovascular Disease and Endothelial Dysfunction, run by Wageningen University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
What is being tested?
high fat meal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNetherlands
Study dates
Oct 2008to Mar 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Wageningen universiteit division of human

    Wageningen, Gelderland, 6703HD

Other trials in Netherlands

About this study

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

Read the 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.

Being tested
high fat meal, control meal
Keywords
endothelium,, postprandial, microvascular, macrovascular
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high fat mealDietary supplement

    milkshake containing 95g fat

  • control mealDietary supplement

    milkshake comparable with a normal breakfast

Study groups in NCT00766623
Study groupRoleWhat they receive
High fat mealExperimentalA high fat milkshake containing 95g of fat
Receives: Dietary Supplement: high fat meal
Control mealExperimentalMilkshake comparable with a normal breakfast
Receives: Dietary Supplement: control meal
High fat meal 2ExperimentalA high fat milkshake containing 95g of fat
Receives: Dietary Supplement: high fat meal
High fat meal 3ExperimentalA high fat milkshake containing 95g of fat
Receives: Dietary Supplement: high fat meal
Control meal 2ExperimentalMilkshake comparable with a normal breakfast
Receives: Dietary Supplement: control meal
Control meal 3ExperimentalMilkshake comparable with a normal breakfast
Receives: Dietary Supplement: control meal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Macrovascular local arterial stiffness by echo-tracking

    Measured: 0, 3, 6 hours

  2. Macrovascular regional arterial stiffness by tonometry

    Measured: 0, 3, 6 h

  3. Macrovascular circulation by flow mediated dilatation

    Measured: 0, 3, 6h

  4. Microvascular circulation by iontophoresis/laser doppler

    Measured: 0, 3, 6h

Secondary outcomes (4)

  1. PBMC gene expression profiles

    Measured: 0, 1, 2, 3, 5, 6 hours

  2. Leukocyte activation markers

    Measured: 0, 3, 6h

  3. cytokine profiles

    Measured: 0, 1, 2, 3, 5, 6 hours

  4. known plasma markers of ED

    Measured: 0, 1, 2, 3, 5, 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionFeb 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00766623
Sponsor's protocol ID
NL23651.081.08
Other IDs
empef, abr23651, 08/10 EMPEF
Acronym
EMPEF
Status last verified
Sep 2009
First submitted
3 Oct 2008
Last updated
29 Sep 2009
Results posted
No
Data monitoring committee
No

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.

    PubMed 23405070

Questions about this trial

What is this clinical trial studying?

A study testing high fat meal in people with Cardiovascular Disease and Endothelial Dysfunction, run by Wageningen University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Macrovascular local arterial stiffness by echo-tracking (time frame: 0, 3, 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00766623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2009.

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