Cardiovascular DiseaseAFASTNCT01000194
Acute Fatty Acid Intervention Study (AFAST)
A study testing High fat meal in people with Cardiovascular Disease and The Metabolic Syndrome, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, The Metabolic Syndrome
- What is being tested?
- High fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian men
- age between 18 and 30 years
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Disease, The Metabolic Syndrome
- Being tested
- High fat meal
- Keywords
- postprandial, gene expression profiles, microarray
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat mealDietary supplement
A high fat milkshake containing 55g of fat
| Study group | Role | What they receive |
|---|---|---|
| High polyunsaturated fat meal | Experimental | A high fat milkshake containing 55g of fat, mainly PUFA Receives: Dietary Supplement: High fat meal |
| High monounsaturated fat meal | Experimental | A high fat milkshake containing 55g of fat, mainly MUFA Receives: Dietary Supplement: High fat meal |
| High saturated fat meal | Experimental | A high fat milkshake containing 55g of fat, mainly SFA Receives: Dietary Supplement: High fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood mononuclear cells (PBMC) gene expression profiles
Measured: 0, 2, 4, 6, 8 hours
Secondary outcomes (4)
Plasma free fatty acid profiles
Measured: 0, 6 hours
Plasma free fatty acids
Measured: 0, 2, 4, 6, 8 hours
Plasma cholesterol
Measured: 0, 2, 4, 6, 8 hours
Plasma triglycerides
Measured: 0, 2, 4, 6, 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startJan 2008
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Dairy Organization (NZO)
- Investigators
- Lydia A Afman, PhD, Study director, Wageningen UniversityMichael Müller, PhD, Study chair, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000194
- Sponsor's protocol ID
- NL19273.081.07
- Other IDs
- ABR19273
- Acronym
- AFAST
- Status last verified
- Oct 2009
- First submitted
- 21 Oct 2009
- Last updated
- 22 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19923369
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Fatty Acid Intervention Study
- ClinicalTrials.gov ID
- NCT01000194
- Acronym / sponsor ID
- AFAST / NL19273.081.07
- Conditions
- Cardiovascular Disease, The Metabolic Syndrome
- Keywords
- postprandial, gene expression profiles, microarray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Dutch Dairy Organization (NZO)
- Study start
- Jan 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High polyunsaturated fat meal | Experimental | Dietary Supplement: High fat mealA high fat milkshake containing 55g of fat, mainly PUFA |
| High monounsaturated fat meal | Experimental | Dietary Supplement: High fat mealA high fat milkshake containing 55g of fat, mainly MUFA |
| High saturated fat meal | Experimental | Dietary Supplement: High fat mealA high fat milkshake containing 55g of fat, mainly SFA |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Caucasian men
- age between 18 and 30 years
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High fat mealA high fat milkshake containing 55g of fat | Dietary supplement | High monounsaturated fat meal, High polyunsaturated fat meal, High saturated fat meal |
Primary outcome
Peripheral blood mononuclear cells (PBMC) gene expression profiles
Time frame: 0, 2, 4, 6, 8 hours
4 secondary outcomes
Plasma free fatty acid profiles
Time frame: 0, 6 hours
Plasma free fatty acids
Time frame: 0, 2, 4, 6, 8 hours
Plasma cholesterol
Time frame: 0, 2, 4, 6, 8 hours
Plasma triglycerides
Time frame: 0, 2, 4, 6, 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2009.
- Derived from this study: PubMed 19923369Bouwens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia A Afman, PhD study director
Wageningen University
Michael Müller, PhD study chair
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fat meal in people with Cardiovascular Disease and The Metabolic Syndrome, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral blood mononuclear cells (PBMC) gene expression profiles (time frame: 0, 2, 4, 6, 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2009.