PIFA: Postprandial Inflammation and Fatty Acids

Sponsor

Wageningen University (Other)

Overall Status

Completed

CT.gov ID

NCT00977262

Collaborator

Dutch Diabetes Research Foundation (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease Diabetes Type 2 Obesity	Other: High saturated fat shake Other: High monounsaturated fat shake Other: High polyunsaturated fat shake	N/A

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

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Official Title:

Effects of Fatty Acids on Postprandial Inflammatory Response of Healthy Obese and Type 2 Diabetic Obese Subjects

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy control subjects, High saturated fat shake	Other: High saturated fat shake milkshake containing 95 gram of fat, high percentage of saturated fat
Experimental: Healthy control subjects, High Monounsaturated fat shake	Other: High monounsaturated fat shake milkshake containing 95 gram of fat, high percentage of monounsaturated fat
Experimental: Healthy control subjects, High Polyunsaturated fat shake	Other: High polyunsaturated fat shake milkshake containing 95 gram of fat, high percentage polyunsaturated fat
Experimental: Healthy obese subjecs, High saturated fat shake	Other: High saturated fat shake milkshake containing 95 gram of fat, high percentage of saturated fat
Experimental: Healthy obese subjects, High monounsaturated fat shake	Other: High monounsaturated fat shake milkshake containing 95 gram of fat, high percentage of monounsaturated fat
Experimental: Healthy obese subjects, High polyunsaturated fat shake	Other: High polyunsaturated fat shake milkshake containing 95 gram of fat, high percentage polyunsaturated fat
Experimental: Obese diabetes type 2 subjects, High Saturated fat shake	Other: High saturated fat shake milkshake containing 95 gram of fat, high percentage of saturated fat
Experimental: Obese diabetes type 2 subjects, High Monounsaturated fat shake	Other: High monounsaturated fat shake milkshake containing 95 gram of fat, high percentage of monounsaturated fat
Experimental: Obese diabetes type 2 subjects, High polyunsaturated fat shake	Other: High polyunsaturated fat shake milkshake containing 95 gram of fat, high percentage polyunsaturated fat

Outcome Measures

Primary Outcome Measures

PBMC gene expression profiles [0, 2, 4 hrs]

Secondary Outcome Measures

PBMC inflammatory response capacity [0, 2, 4 hrs]
Endothelial function [0, 2, 4 hrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wageningen University, Division of Human Nutrition	Wageningen	Gelderland	Netherlands	6700 EV
2	Wageningen University, Division of Human Nutrition	Wageningen		Netherlands	6700 EV

Sponsors and Collaborators

Wageningen University
Dutch Diabetes Research Foundation

Investigators

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