Status:
COMPLETED
Postprandial Inflammation and Fatty Acids
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Dutch Diabetes Research Foundation
Conditions:
Cardiovascular Disease
Diabetes Type 2
Eligibility:
MALE
50-70 years
Phase:
NA
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 exp...
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 peri...
Eligibility Criteria
Inclusion
- 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.
- 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)
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00977262
Start Date
October 1 2009
End Date
December 1 2009
Last Update
April 21 2010
Active Locations (2)
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1
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, Netherlands, 6700 EV
2
Wageningen University, Division of Human Nutrition
Wageningen, Netherlands, 6700 EV