Acute Fatty Acid Intervention Study (AFAST) (AFAST)
Primary Purpose
Cardiovascular Disease, The Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
High fat meal
Sponsored by
About this trial
This is an interventional basic science trial for Cardiovascular Disease focused on measuring postprandial, gene expression profiles, microarray
Eligibility 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
Sites / Locations
- Wageningen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
High polyunsaturated fat meal
High monounsaturated fat meal
High saturated fat meal
Arm Description
A high fat milkshake containing 55g of fat, mainly PUFA
A high fat milkshake containing 55g of fat, mainly MUFA
A high fat milkshake containing 55g of fat, mainly SFA
Outcomes
Primary Outcome Measures
Peripheral blood mononuclear cells (PBMC) gene expression profiles
Secondary Outcome Measures
Plasma free fatty acid profiles
Plasma free fatty acids
Plasma cholesterol
Plasma triglycerides
Full Information
NCT ID
NCT01000194
First Posted
October 21, 2009
Last Updated
October 21, 2009
Sponsor
Wageningen University
Collaborators
Dutch Dairy Organization (NZO)
1. Study Identification
Unique Protocol Identification Number
NCT01000194
Brief Title
Acute Fatty Acid Intervention Study (AFAST)
Acronym
AFAST
Official Title
Acute Fatty Acid Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wageningen University
Collaborators
Dutch Dairy Organization (NZO)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, The Metabolic Syndrome
Keywords
postprandial, gene expression profiles, microarray
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High polyunsaturated fat meal
Arm Type
Experimental
Arm Description
A high fat milkshake containing 55g of fat, mainly PUFA
Arm Title
High monounsaturated fat meal
Arm Type
Experimental
Arm Description
A high fat milkshake containing 55g of fat, mainly MUFA
Arm Title
High saturated fat meal
Arm Type
Experimental
Arm Description
A high fat milkshake containing 55g of fat, mainly SFA
Intervention Type
Dietary Supplement
Intervention Name(s)
High fat meal
Intervention Description
A high fat milkshake containing 55g of fat
Primary Outcome Measure Information:
Title
Peripheral blood mononuclear cells (PBMC) gene expression profiles
Time Frame
0, 2, 4, 6, 8 hours
Secondary Outcome Measure Information:
Title
Plasma free fatty acid profiles
Time Frame
0, 6 hours
Title
Plasma free fatty acids
Time Frame
0, 2, 4, 6, 8 hours
Title
Plasma cholesterol
Time Frame
0, 2, 4, 6, 8 hours
Title
Plasma triglycerides
Time Frame
0, 2, 4, 6, 8 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia A Afman, PhD
Organizational Affiliation
Wageningen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Müller, PhD
Organizational Affiliation
Wageningen University
Official's Role
Study Chair
Facility Information:
Facility Name
Wageningen University
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6700 AH
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19923369
Citation
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.
Results Reference
derived
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Acute Fatty Acid Intervention Study (AFAST)
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