- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01000194
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
Conditions
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL19273.081.07
- ABR19273
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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