Postprandial Inflammation and Fatty Acids
PIFA
Effects of Fatty Acids on Postprandial Inflammatory Response of Healthy Obese and Type 2 Diabetic Obese Subjects
1 other identifier
interventional
42
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2009
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 15, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedApril 21, 2010
April 1, 2010
2 months
September 11, 2009
April 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PBMC gene expression profiles
0, 2, 4 hrs
Secondary Outcomes (2)
PBMC inflammatory response capacity
0, 2, 4 hrs
Endothelial function
0, 2, 4 hrs
Study Arms (9)
Healthy control subjects, High saturated fat shake
EXPERIMENTALHealthy control subjects, High Monounsaturated fat shake
EXPERIMENTALHealthy control subjects, High Polyunsaturated fat shake
EXPERIMENTALHealthy obese subjecs, High saturated fat shake
EXPERIMENTALHealthy obese subjects, High monounsaturated fat shake
EXPERIMENTALHealthy obese subjects, High polyunsaturated fat shake
EXPERIMENTALObese diabetes type 2 subjects, High Saturated fat shake
EXPERIMENTALObese diabetes type 2 subjects, High Monounsaturated fat shake
EXPERIMENTALObese diabetes type 2 subjects, High polyunsaturated fat shake
EXPERIMENTALInterventions
milkshake containing 95 gram of fat, high percentage of saturated fat
milkshake containing 95 gram of fat, high percentage of monounsaturated fat
milkshake containing 95 gram of fat, high percentage polyunsaturated fat
Eligibility Criteria
You may qualify if:
- For all participants:
- male gender
- 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.
- 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)
You may not qualify if:
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- Dutch Diabetes Research Foundationcollaborator
Study Sites (2)
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, 6700 EV, Netherlands
Wageningen University, Division of Human Nutrition
Wageningen, 6700 EV, Netherlands
Related Publications (2)
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.
PMID: 23616512DERIVEDvan 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.
PMID: 22844471DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Muller, Prof
Chair Department of Human Nutrition NMG group
- PRINCIPAL INVESTIGATOR
Lydia A Afman, PhD
Senior scientist department Human Nutrition Wageningen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 15, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
April 21, 2010
Record last verified: 2010-04