Acute Fatty Acid Intervention Study (AFAST) (AFAST)

October 21, 2009 updated by: Wageningen University

Acute Fatty Acid Intervention Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Nutrition plays a key role in the development of metabolic disorders like cardiovascular disease and the metabolic syndrome. Nutrients that can contribute to the risk of developing such diseases are fatty acids (FAs). It is known that fatty acids mediate their metabolic effects via changes in gene expression, through binding and subsequent activation of the transcription factor peroxisome proliferator-activated receptor (PPAR). In addition, it is known that unsaturated fatty acids are better ligands for PPAR than saturated fatty acids. Peripheral blood mononuclear cells (PBMC) express PPARalpha and are relatively easy to isolate from whole blood. We previously showed that the gene expression profiles of these cells can reflect free fatty acid increases during fasting. The question still remains whether dietary FA can influence gene expression in a similar way and, if so, whether different dietary FA result in different gene expression changes and subsequent activation of other pathways.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6700 AH
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy Caucasian men
  • age between 18 and 30 years

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High polyunsaturated fat meal
A high fat milkshake containing 55g of fat, mainly PUFA
A high fat milkshake containing 55g of fat
Experimental: High monounsaturated fat meal
A high fat milkshake containing 55g of fat, mainly MUFA
A high fat milkshake containing 55g of fat
Experimental: High saturated fat meal
A high fat milkshake containing 55g of fat, mainly SFA
A high fat milkshake containing 55g of fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peripheral blood mononuclear cells (PBMC) gene expression profiles
Time Frame: 0, 2, 4, 6, 8 hours
0, 2, 4, 6, 8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma free fatty acid profiles
Time Frame: 0, 6 hours
0, 6 hours
Plasma free fatty acids
Time Frame: 0, 2, 4, 6, 8 hours
0, 2, 4, 6, 8 hours
Plasma cholesterol
Time Frame: 0, 2, 4, 6, 8 hours
0, 2, 4, 6, 8 hours
Plasma triglycerides
Time Frame: 0, 2, 4, 6, 8 hours
0, 2, 4, 6, 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Lydia A Afman, PhD, Wageningen University
  • Study Chair: Michael Müller, PhD, Wageningen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (Estimate)

October 22, 2009

Study Record Updates

Last Update Posted (Estimate)

October 22, 2009

Last Update Submitted That Met QC Criteria

October 21, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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