Cardiovascular DiseasePIFANCT00977262
Postprandial Inflammation and Fatty Acids
A study testing High saturated fat shake, High monounsaturated fat shake and High polyunsaturated fat shake in people with Cardiovascular Disease and Diabetes Type 2, run by Wageningen University at 2 sites in Netherlands.
Trial summary
The main objective is to elucidate the acute effects of an oral intake of either saturated, monounsaturated or polyunsaturated fatty acids on peripheral blood mononuclear cells (PBMC) whole genome expression of obese and type 2 diabetic obese subjects. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Diabetes Type 2, Obesity
- What is being tested?
- High saturated fat shake, High monounsaturated fat shake and High polyunsaturated fat shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2009to Dec 2009
- 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 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all participants:
- male gender
- 50-70 yrs
- For diabetic patients only:
- BMI >30 kg/m2
- Well-controlled diabetes: fasting plasma glucose concentration must be <10.0 mmol/l at the time of screening.
Show all 13Show fewer
- Must be on sulphonylurea- or metformin therapy for at least 6 months with a constant dose for at least two months, or on dietary treatment for at least 6 months2.
- For obese controls only:
- BMI > 30 kg/m2
- normoglycemic according to WHO criteria (OGTT, fasting blood glucose< 7 mmol/L, after 2 hr <7.8mmol/L)
- For lean controls only:
- BMI 18-25 kg/m2
- normoglycemic according to WHO criteria (OGTT, fasting blood glucose< 7 mmol/L, after 2 hr <7.8mmol/L)
Who cannot join
- For all participants:
- Female gender
- Age below 50 or above 70 years
- Hemoglobin levels <8.4 mmol/L
- Allergic to cow milk or dairy products
- Allergic to fish oil
Show all 23Show fewer
- Vegetarian
- Tobacco smoker
- 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.
- 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
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, gastrointestinal disease, renal dysfunction)
- Use of medications know to interfere with glucose homeostasis (i.e. corticosteroids)
- abuse of drugs and/or alcohol
- participation in another biomedical study within 1 month before the first screening visit
- For obese, type 2 diabetic subjects only:
- severe diabetes which requires application of insulin
- diabetes-related complications
- For obese subjects and lean controls only:
- hyperglycemic according to WHO criteria (OGTT, fasting blood glucose >6.0mM, after 2 hr>11mM)
- systolic blood pressure >160 mmHg or diastolic blood pressure > 100 mmHg
- Urinary glucose concentrations (>0.25 g/l)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, 6700 EV
Wageningen University, Division of Human Nutrition
Wageningen, 6700 EV
About this study
Official title: Effects of Fatty Acids on Postprandial Inflammatory Response of Healthy Obese and Type 2 Diabetic Obese Subjects
The main objective is to elucidate the acute effects of an oral intake of either saturated, monounsaturated or polyunsaturated fatty acids on peripheral blood mononuclear cells (PBMC) whole genome expression of obese and type 2 diabetic obese subjects.
Read the detailed description
Consumption of high-fat diets can lead to postprandial dyslipidemia, impairment of endothelial function, activation of immune cells and changes in gene expression profiles of immune cells such as peripheral blood mononuclear cells (PBMC). Recently it was shown that postprandial gene expression profiles of PBMC and plasma triglyceride (TG) and free fatty acid (FFA) responses are dependent on the type of dietary fat consumed (i.e. saturated, monounsaturated and polyunsaturated). Since obese and diabetic subjects usually are in a pro-inflammatory state and have dyslipidemia and endothelial dysfunction we are interested in the effect of different fatty acids in a high load on the PBMC gene expression profiles, plasma cytokine profiles and endothelial function of these subjects.
- Conditions
- Cardiovascular Disease, Diabetes Type 2, Obesity
- Being tested
- High saturated fat shake, High monounsaturated fat shake, High polyunsaturated fat shake
- Keywords
- fatty acids, peripheral blood mononuclear cells, inflammation, nutrigenomics
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High saturated fat shakeOther
milkshake containing 95 gram of fat, high percentage of saturated fat
High monounsaturated fat shakeOther
milkshake containing 95 gram of fat, high percentage of monounsaturated fat
High polyunsaturated fat shakeOther
milkshake containing 95 gram of fat, high percentage polyunsaturated fat
| Study group | Role | What they receive |
|---|---|---|
| Healthy control subjects, High saturated fat shake | Experimental | Not described Receives: Other: High saturated fat shake |
| Healthy control subjects, High Monounsaturated fat shake | Experimental | Not described Receives: Other: High monounsaturated fat shake |
| Healthy control subjects, High Polyunsaturated fat shake | Experimental | Not described Receives: Other: High polyunsaturated fat shake |
| Healthy obese subjecs, High saturated fat shake | Experimental | Not described Receives: Other: High saturated fat shake |
| Healthy obese subjects, High monounsaturated fat shake | Experimental | Not described Receives: Other: High monounsaturated fat shake |
| Healthy obese subjects, High polyunsaturated fat shake | Experimental | Not described Receives: Other: High polyunsaturated fat shake |
| Obese diabetes type 2 subjects, High Saturated fat shake | Experimental | Not described Receives: Other: High saturated fat shake |
| Obese diabetes type 2 subjects, High Monounsaturated fat shake | Experimental | Not described Receives: Other: High monounsaturated fat shake |
| Obese diabetes type 2 subjects, High polyunsaturated fat shake | Experimental | Not described Receives: Other: High polyunsaturated fat shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
PBMC gene expression profiles
Measured: 0, 2, 4 hrs
Secondary outcomes (2)
PBMC inflammatory response capacity
Measured: 0, 2, 4 hrs
Endothelial function
Measured: 0, 2, 4 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Investigators
- Michael Muller, Prof, Study chair, Chair Department of Human Nutrition NMG groupLydia A Afman, PhD, Principal investigator, Senior scientist department Human Nutrition Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977262
- Sponsor's protocol ID
- NL2800108109
- Acronym
- PIFA
- Status last verified
- Apr 2010
- First submitted
- 11 Sep 2009
- Last updated
- 21 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Esser D, van Dijk SJ, Oosterink E, Muller M, Afman LA. A high-fat SFA, MUFA, or n3 PUFA challenge affects the vascular response and initiates an activated state of cellular adherence in lean and obese middle-aged men. J Nutr. 2013 Jun;143(6):843-51. doi: 10.3945/jn.113.174540. Epub 2013 Apr 24.
PubMed 23616512van Dijk SJ, Mensink M, Esser D, Feskens EJ, Muller M, Afman LA. Responses to high-fat challenges varying in fat type in subjects with different metabolic risk phenotypes: a randomized trial. PLoS One. 2012;7(7):e41388. doi: 10.1371/journal.pone.0041388. Epub 2012 Jul 23.
PubMed 22844471
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fatty Acids on Postprandial Inflammatory Response of Healthy Obese and Type 2 Diabetic Obese Subjects
- ClinicalTrials.gov ID
- NCT00977262
- Acronym / sponsor ID
- PIFA / NL2800108109
- Conditions
- Cardiovascular Disease, Diabetes Type 2, Obesity
- Keywords
- fatty acids, peripheral blood mononuclear cells, inflammation, nutrigenomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Sep 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 is to elucidate the acute effects of an oral intake of either saturated, monounsaturated or polyunsaturated fatty acids on peripheral blood mononuclear cells (PBMC) whole genome expression of obese and type 2 diabetic obese subjects.
Detailed description
Consumption of high-fat diets can lead to postprandial dyslipidemia, impairment of endothelial function, activation of immune cells and changes in gene expression profiles of immune cells such as peripheral blood mononuclear cells (PBMC). Recently it was shown that postprandial gene expression profiles of PBMC and plasma triglyceride (TG) and free fatty acid (FFA) responses are dependent on the type of dietary fat consumed (i.e. saturated, monounsaturated and polyunsaturated). Since obese and diabetic subjects usually are in a pro-inflammatory state and have dyslipidemia and endothelial dysfunction we are interested in the effect of different fatty acids in a high load on the PBMC gene expression profiles, plasma cytokine profiles and endothelial function of these subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Healthy control subjects, High saturated fat shake | Experimental | Other: High saturated fat shake |
| Healthy control subjects, High Monounsaturated fat shake | Experimental | Other: High monounsaturated fat shake |
| Healthy control subjects, High Polyunsaturated fat shake | Experimental | Other: High polyunsaturated fat shake |
| Healthy obese subjecs, High saturated fat shake | Experimental | Other: High saturated fat shake |
| Healthy obese subjects, High monounsaturated fat shake | Experimental | Other: High monounsaturated fat shake |
| Healthy obese subjects, High polyunsaturated fat shake | Experimental | Other: High polyunsaturated fat shake |
| Obese diabetes type 2 subjects, High Saturated fat shake | Experimental | Other: High saturated fat shake |
| Obese diabetes type 2 subjects, High Monounsaturated fat shake | Experimental | Other: High monounsaturated fat shake |
| Obese diabetes type 2 subjects, High polyunsaturated fat shake | Experimental | Other: High polyunsaturated fat shake |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- male gender
- 50-70 yrs
- BMI >30 kg/m2
- Well-controlled diabetes: fasting plasma glucose concentration must be <10.0 mmol/l at the time of screening.
- Must be on sulphonylurea- or metformin therapy for at least 6 months with a constant dose for at least two months, or on dietary treatment for at least 6 months2.
Key exclusion criteria (23 listed)
- Female gender
- Age below 50 or above 70 years
- Hemoglobin levels <8.4 mmol/L
- Allergic to cow milk or dairy products
- Allergic to fish oil
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 saturated fat shakemilkshake containing 95 gram of fat, high percentage of saturated fat | Other | Healthy control subjects, High saturated fat shake, Healthy obese subjecs, High saturated fat shake, Obese diabetes type 2 subjects, High Saturated fat shake |
| High monounsaturated fat shakemilkshake containing 95 gram of fat, high percentage of monounsaturated fat | Other | Healthy control subjects, High Monounsaturated fat shake, Healthy obese subjects, High monounsaturated fat shake, Obese diabetes type 2 subjects, High Monounsaturated fat shake |
| High polyunsaturated fat shakemilkshake containing 95 gram of fat, high percentage polyunsaturated fat | Other | Healthy control subjects, High Polyunsaturated fat shake, Healthy obese subjects, High polyunsaturated fat shake, Obese diabetes type 2 subjects, High polyunsaturated fat shake |
Primary outcome
PBMC gene expression profiles
Time frame: 0, 2, 4 hrs
2 secondary outcomes
PBMC inflammatory response capacity
Time frame: 0, 2, 4 hrs
Endothelial function
Time frame: 0, 2, 4 hrs
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 21 Apr 2010.
- Derived from this study: PubMed 23616512Esser D, van Dijk SJ, Oosterink E, Muller M, Afman LA. A high-fat SFA, MUFA, or n3 PUFA challenge affects the vascular response and initiates an activated state of cellular adherence in lean and obese middle-aged men. J Nutr. 2013 Jun;143(6):843-51. doi: 10.3945/jn.113.174540. Epub 2013 Apr 24.
- Derived from this study: PubMed 22844471van Dijk SJ, Mensink M, Esser D, Feskens EJ, Muller M, Afman LA. Responses to high-fat challenges varying in fat type in subjects with different metabolic risk phenotypes: a randomized trial. PLoS One. 2012;7(7):e41388. doi: 10.1371/journal.pone.0041388. Epub 2012 Jul 23.
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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.
Michael Muller, Prof study chair
Chair Department of Human Nutrition NMG group
Lydia A Afman, PhD principal investigator
Senior scientist department Human Nutrition Wageningen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High saturated fat shake, High monounsaturated fat shake and High polyunsaturated fat shake in people with Cardiovascular Disease and Diabetes Type 2, run by Wageningen University at 2 sites 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 13 inclusion and 23 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 21 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
PBMC gene expression profiles (time frame: 0, 2, 4 hrs). 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 NCT00977262, which also lists 2 linked publications.
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 21 Apr 2010.