NCT00766623

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 29, 2009

Status Verified

September 1, 2009

Enrollment Period

4 months

First QC Date

October 3, 2008

Last Update Submit

September 28, 2009

Conditions

Cardiovascular DiseaseEndothelial Dysfunction

Keywords

endothelium,postprandialmicrovascularmacrovascular

Outcome Measures

Primary Outcomes (4)

  • Macrovascular local arterial stiffness by echo-tracking

    0, 3, 6 hours

  • Macrovascular regional arterial stiffness by tonometry

    0, 3, 6 h

  • Macrovascular circulation by flow mediated dilatation

    0, 3, 6h

  • Microvascular circulation by iontophoresis/laser doppler

    0, 3, 6h

Secondary Outcomes (4)

  • PBMC gene expression profiles

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

  • Leukocyte activation markers

    0, 3, 6h

  • cytokine profiles

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

  • known plasma markers of ED

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

Study Arms (6)

High fat meal

EXPERIMENTAL

A high fat milkshake containing 95g of fat

Dietary Supplement: high fat meal

Control meal

EXPERIMENTAL

Milkshake comparable with a normal breakfast

Dietary Supplement: control meal

High fat meal 2

EXPERIMENTAL

A high fat milkshake containing 95g of fat

Dietary Supplement: high fat meal

High fat meal 3

EXPERIMENTAL

A high fat milkshake containing 95g of fat

Dietary Supplement: high fat meal

Control meal 2

EXPERIMENTAL

Milkshake comparable with a normal breakfast

Dietary Supplement: control meal

Control meal 3

EXPERIMENTAL

Milkshake comparable with a normal breakfast

Dietary Supplement: control meal

Interventions

high fat mealDIETARY_SUPPLEMENT

milkshake containing 95g fat

High fat mealHigh fat meal 2High fat meal 3
control mealDIETARY_SUPPLEMENT

milkshake comparable with a normal breakfast

Control mealControl meal 2Control meal 3

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male, caucasian

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen universiteit division of human

Wageningen, Gelderland, 6703HD, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 23405070DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Michael Müller, Prof.Dr

    Chair Department of human nutrition NMG group

    STUDY CHAIR

  • Lydia A Afman, PhD

    Senior scientist department Human Nutrition Wageningen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

September 29, 2009

Record last verified: 2009-09

Locations

NL(1)