Obesity Clinical Trial
— PIFAOfficial 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.
Status | Completed |
Enrollment | 42 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 50 Years to 70 Years |
Eligibility |
Inclusion Criteria: 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 Criteria: 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) |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University, Division of Human Nutrition | Wageningen | Gelderland |
Netherlands | Wageningen University, Division of Human Nutrition | Wageningen |
Lead Sponsor | Collaborator |
---|---|
Wageningen University | Dutch Diabetes Research Foundation |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PBMC gene expression profiles | 0, 2, 4 hrs | No | |
Secondary | PBMC inflammatory response capacity | 0, 2, 4 hrs | No | |
Secondary | Endothelial function | 0, 2, 4 hrs | No |
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