Postprandial Inflammation and Fatty Acids (PIFA)

This study has been completed.
Sponsor:
Collaborator:
Dutch Diabetes Research Foundation
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00977262
First received: September 11, 2009
Last updated: April 20, 2010
Last verified: April 2010
  Purpose

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 Intervention
Cardiovascular Disease
Diabetes Type 2
Obesity
Other: High saturated fat shake
Other: High monounsaturated fat shake
Other: High polyunsaturated fat shake

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Fatty Acids on Postprandial Inflammatory Response of Healthy Obese and Type 2 Diabetic Obese Subjects

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • PBMC gene expression profiles [ Time Frame: 0, 2, 4 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PBMC inflammatory response capacity [ Time Frame: 0, 2, 4 hrs ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: 0, 2, 4 hrs ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977262

Locations
Netherlands
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, Netherlands, 6700 EV
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
  More Information

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wageningen University, Division of Human Nutrition, Wageningen University
ClinicalTrials.gov Identifier: NCT00977262     History of Changes
Other Study ID Numbers: NL2800108109
Study First Received: September 11, 2009
Last Updated: April 20, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:
fatty acids
peripheral blood mononuclear cells
inflammation
nutrigenomics

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014