Acute Fatty Acid Intervention Study (AFAST)

This study has been completed.
Sponsor:
Collaborator:
Dutch Dairy Organization (NZO)
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT01000194
First received: October 21, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 21, 2009
October 21, 2009
January 2008
March 2008   (final data collection date for primary outcome measure)
Peripheral blood mononuclear cells (PBMC) gene expression profiles [ Time Frame: 0, 2, 4, 6, 8 hours ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Plasma free fatty acid profiles [ Time Frame: 0, 6 hours ] [ Designated as safety issue: No ]
  • Plasma free fatty acids [ Time Frame: 0, 2, 4, 6, 8 hours ] [ Designated as safety issue: No ]
  • Plasma cholesterol [ Time Frame: 0, 2, 4, 6, 8 hours ] [ Designated as safety issue: No ]
  • Plasma triglycerides [ Time Frame: 0, 2, 4, 6, 8 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acute Fatty Acid Intervention Study (AFAST)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Cardiovascular Disease
  • The Metabolic Syndrome
Dietary Supplement: High fat meal
A high fat milkshake containing 55g of fat
  • Experimental: High polyunsaturated fat meal
    A high fat milkshake containing 55g of fat, mainly PUFA
    Intervention: Dietary Supplement: High fat meal
  • Experimental: High monounsaturated fat meal
    A high fat milkshake containing 55g of fat, mainly MUFA
    Intervention: Dietary Supplement: High fat meal
  • Experimental: High saturated fat meal
    A high fat milkshake containing 55g of fat, mainly SFA
    Intervention: Dietary Supplement: High fat meal
Bouwens M, Grootte Bromhaar M, Jansen J, Müller 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. Epub 2009 Nov 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01000194
NL19273.081.07, ABR19273
No
Wageningen University, Department of human nutrition, Wageningen University
Wageningen University
Dutch Dairy Organization (NZO)
Study Director: Lydia A Afman, PhD Wageningen University
Study Chair: Michael Müller, PhD Wageningen University
Wageningen University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP