Postprandial Inflammation and Fatty Acids

NCT ID: NCT00977262

Last Updated: 2010-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2009-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

Healthy control subjects, High saturated fat shake

Group Type: EXPERIMENTAL

High saturated fat shake

Intervention Type: OTHER

milkshake containing 95 gram of fat, high percentage of saturated fat

Healthy control subjects, High Monounsaturated fat shake

Group Type: EXPERIMENTAL

High monounsaturated fat shake

Intervention Type: OTHER

milkshake containing 95 gram of fat, high percentage of monounsaturated fat

Healthy control subjects, High Polyunsaturated fat shake

Group Type: EXPERIMENTAL

High polyunsaturated fat shake

Intervention Type: OTHER

milkshake containing 95 gram of fat, high percentage polyunsaturated fat

Healthy obese subjecs, High saturated fat shake

Group Type: EXPERIMENTAL

High saturated fat shake

Intervention Type: OTHER

milkshake containing 95 gram of fat, high percentage of saturated fat

Healthy obese subjects, High monounsaturated fat shake

Group Type: EXPERIMENTAL

High monounsaturated fat shake

Intervention Type: OTHER

milkshake containing 95 gram of fat, high percentage of monounsaturated fat

Healthy obese subjects, High polyunsaturated fat shake

Group Type: EXPERIMENTAL

High polyunsaturated fat shake

Intervention Type: OTHER

milkshake containing 95 gram of fat, high percentage polyunsaturated fat

Obese diabetes type 2 subjects, High Saturated fat shake

Group Type: EXPERIMENTAL

High saturated fat shake

Intervention Type: OTHER

milkshake containing 95 gram of fat, high percentage of saturated fat

Obese diabetes type 2 subjects, High Monounsaturated fat shake

Group Type: EXPERIMENTAL

High monounsaturated fat shake

Intervention Type: OTHER

milkshake containing 95 gram of fat, high percentage of monounsaturated fat

Obese diabetes type 2 subjects, High polyunsaturated fat shake

Group Type: EXPERIMENTAL

High polyunsaturated fat shake

Intervention Type: OTHER

milkshake containing 95 gram of fat, high percentage polyunsaturated fat

Interventions

High saturated fat shake

milkshake containing 95 gram of fat, high percentage of saturated fat

Intervention Type: OTHER

High monounsaturated fat shake

milkshake containing 95 gram of fat, high percentage of monounsaturated fat

Intervention Type: OTHER

High polyunsaturated fat shake

milkshake containing 95 gram of fat, high percentage polyunsaturated fat

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dutch Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Wageningen University

Principal Investigators

Michael Muller, Prof

Role: STUDY_CHAIR

Chair Department of Human Nutrition NMG group

Lydia A Afman, PhD

Role: PRINCIPAL_INVESTIGATOR

Senior scientist department Human Nutrition Wageningen University

Locations

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, Netherlands

Wageningen University, Division of Human Nutrition

Wageningen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 23616512 (View on PubMed)

van 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.

Reference Type: DERIVED

PMID: 22844471 (View on PubMed)

Other Identifiers

NL2800108109

Identifier Type: -

Identifier Source: org_study_id