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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
  Purpose

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.


Condition Intervention
Cardiovascular Disease
The Metabolic Syndrome
 Dietary Supplement: High fat meal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Acute Fatty Acid Intervention Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Peripheral blood mononuclear cells (PBMC) gene expression profiles [ Time Frame: 0, 2, 4, 6, 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: January 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High polyunsaturated fat meal
A high fat milkshake containing 55g of fat, mainly PUFA
 Dietary Supplement: High fat meal
A high fat milkshake containing 55g of fat
Experimental: High monounsaturated fat meal
A high fat milkshake containing 55g of fat, mainly MUFA
 Dietary Supplement: High fat meal
A high fat milkshake containing 55g of fat
Experimental: High saturated fat meal
A high fat milkshake containing 55g of fat, mainly SFA
 Dietary Supplement: High fat meal
A high fat milkshake containing 55g of fat

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000194

Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 AH
Sponsors and Collaborators
Wageningen University
Dutch Dairy Organization (NZO)
Investigators
Study Director: Lydia A Afman, PhD Wageningen University
Study Chair: Michael Müller, PhD Wageningen University
  More Information

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wageningen University, Department of human nutrition, Wageningen University
ClinicalTrials.gov Identifier: NCT01000194     History of Changes
Other Study ID Numbers: NL19273.081.07, ABR19273
Study First Received: October 21, 2009
Last Updated: October 21, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:
postprandial
gene expression profiles
microarray

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Insulin Resistance
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013