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Completed

NCT Number: NCT01000194

Acute Fatty Acid Intervention Study (AFAST)

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6700 AH, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High fat meal

Dietary Supplement

A high fat milkshake containing 55g of fat

Primary outcomes

  1. Peripheral blood mononuclear cells (PBMC) gene expression profiles

    Time frame: 0, 2, 4, 6, 8 hours

Secondary outcomes

  1. Plasma free fatty acid profiles

    Time frame: 0, 6 hours

  2. Plasma free fatty acids

    Time frame: 0, 2, 4, 6, 8 hours

  3. Plasma cholesterol

    Time frame: 0, 2, 4, 6, 8 hours

  4. Plasma triglycerides

    Time frame: 0, 2, 4, 6, 8 hours

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Dutch Dairy Organization (NZO)

Registry information

Official study title

Acute Fatty Acid Intervention Study

Acronym: AFAST

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 22, 2009
Registry last updated
Oct 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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