NCT01000194

Brief Summary

The main objective of this study is to elucidate whether different dietary fatty acids (SFA, PUFA, butter fat and margarine fat) in a high fat load will have different effects on PBMC gene expression profiles. Secondary objectives are to elucidate the effects of these fat loads on individual plasma free fatty acid profiles, triglycerides and cholesterol levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
Last Updated

October 22, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

October 21, 2009

Last Update Submit

October 21, 2009

Conditions

Cardiovascular DiseaseThe Metabolic Syndrome

Keywords

postprandialgene expression profilesmicroarray

Outcome Measures

Primary Outcomes (1)

  • Peripheral blood mononuclear cells (PBMC) gene expression profiles

    0, 2, 4, 6, 8 hours

Secondary Outcomes (4)

  • Plasma free fatty acid profiles

    0, 6 hours

  • Plasma free fatty acids

    0, 2, 4, 6, 8 hours

  • Plasma cholesterol

    0, 2, 4, 6, 8 hours

  • Plasma triglycerides

    0, 2, 4, 6, 8 hours

Study Arms (3)

High polyunsaturated fat meal

EXPERIMENTAL

A high fat milkshake containing 55g of fat, mainly PUFA

Dietary Supplement: High fat meal

High monounsaturated fat meal

EXPERIMENTAL

A high fat milkshake containing 55g of fat, mainly MUFA

Dietary Supplement: High fat meal

High saturated fat meal

EXPERIMENTAL

A high fat milkshake containing 55g of fat, mainly SFA

Dietary Supplement: High fat meal

Interventions

High fat mealDIETARY_SUPPLEMENT

A high fat milkshake containing 55g of fat

High monounsaturated fat mealHigh polyunsaturated fat mealHigh saturated fat meal

Eligibility Criteria

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

You may qualify if:

  • Healthy Caucasian men
  • age between 18 and 30 years

You may not qualify if:

  • Allergic to fish oil
  • Allergic to margarine
  • Allergic to cow milk or dairy products
  • Current or recent (\<4 weeks) use of fish oil supplements or more then four times fish/week; 24.35 g of EPA-DHA of fish per month (800 mg/day) as judged by the questionnaire.
  • Body mass index (BMI) \< 18 or \> 25 kg/m2
  • Urine glucose concentrations outside normal ranges (low to non-detectable)
  • Fasting blood glucose outside the normal range (3 - 5.5 mmol/L)
  • Tobacco smoking
  • Taking medication that may influence the study results
  • 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
  • Diagnosed with any long-term medical condition (eg., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease)
  • Vegetarian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6700 AH, Netherlands

Location

Related Publications (1)

  • Bouwens M, Grootte Bromhaar M, Jansen J, Muller M, Afman LA. Postprandial dietary lipid-specific effects on human peripheral blood mononuclear cell gene expression profiles. Am J Clin Nutr. 2010 Jan;91(1):208-17. doi: 10.3945/ajcn.2009.28586. Epub 2009 Nov 18.

    PMID: 19923369DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Lydia A Afman, PhD

    Wageningen University

    STUDY DIRECTOR

  • Michael Müller, PhD

    Wageningen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 22, 2009

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 22, 2009

Record last verified: 2009-10

Locations

NL(1)