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Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age

Primary Purpose

Healthy, Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mashed potatoes
Mashed potatoes + Oleic acid
mashed potatoes + Palmitic acid
Sponsored by
Yves Boirie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Healthy focused on measuring Inflammatory response, High-fat meal, cytokines, Body composition

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject giving his written informed consent
  • Male from 20 to 35 years old and more than 60
  • Affiliated to the French National Health Insurance
  • Body mass index (BMI) ≤ 25kg/m² and waist circumference ≤94cm ; or BMI ≥ 28kg/m² and waist circumference ≥ 102cm.
  • Complete blood count (CBC)-platelet, normal liver function and normal coagulation.
  • Serology of Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) negative
  • normal Thyroid Stimulating Hormone(TSH)

Exclusion Criteria:

  • Previous medical and/or surgery judged by the investigator as incompatible with this study
  • Glaucoma
  • C-reactive protein > 10 mg/l
  • people over 120 kg
  • People with triglyceridemia > 3 g/L or with familial hypercholesterolemia
  • Fasting glycemia > 1,26 g/l, abnormal Oral Glucose Tolerance Test
  • Dietary habits judged by the dietitian as incompatible with the study aim
  • Vegetarians
  • Nutritional allergies or xylocaïn allergy
  • People with eating disorders
  • Heavy consumer of alcohol or cigarette
  • Practising intensive physical exercise
  • People with medication that could interfere with the measured parameters: beta-blockers, statins, anticoagulants, antiplatelet agents, corticosteroids for more than 8 days.
  • Depression or psychiatric treatment
  • Being under someone's supervision
  • Refusal to be registered on the National Volunteers Data file or refusal to sign the consent form
  • Being in exclusion on the National Volunteers Data file
  • Blood donation into the last two months preceding the study

Sites / Locations

  • Human nutrition laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

mashed potatoes

Mashed potatoes + Oleic Acid

Mashed potatoes + Palmitic Acid

Arm Description

Mashed potatoes is composed of potatoes and Skim milk powder.

The test meal is mashed potatoes with 1g/Kg of weight of lipids with 75% of Oleic Acid

The test meal is mashed potatoes with 1g/Kg of weight of lipids with 39% of saturated fat with 32% of palmitic acid.

Outcomes

Primary Outcome Measures

Inflammatory profile by interleukin-6 (IL6) concentration in plasma.

Secondary Outcome Measures

Muscular strength, Body composition
Total plasma lipids (total cholesterol, HDL-Cholesterol, LDL-cholesterol, Triglycerides (TG), non-esterified fatty acid, Plasma hormonal profile, Plasma inflammatory profile, Markers of Endothelial function, Plasma lipopolysaccharide concentration.
Pro-inflammatory cytokines expression in subcutaneous adipose tissue
Urinary metabolomic profile

Full Information

First Posted
February 9, 2010
Last Updated
March 24, 2015
Sponsor
Yves Boirie
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne, ITERG
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1. Study Identification

Unique Protocol Identification Number
NCT01066091
Brief Title
Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age
Official Title
Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yves Boirie
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne, ITERG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial inflammatory response. It is supposed that there is a relationship between the postprandial inflammatory response and the repartition of fat and lean mass, which could partially explain the muscle mass loss with age. The aim of this study is to compare the inflammatory response of a normal meal or high fat meal (from different fatty acids sources) between young lean and young obese and aged lean and aged obese men.
Detailed Description
32 healthy volunteers will be separated into four groups: 8 young lean men, 8 young obese men, 8 aged lean men and 8 aged obese men. They will come to the center four times after inclusion, with 2 to 4 weeks wash out each time. At the first visit they will undergo different test to evaluate their body composition, glucose tolerance, resting energy expenditure, and muscular strength. At the other three visits, people will undergo a kinetic blood sampling, urine and biopsies of adipose tissue over a period of 8h after ingestion of a test meal. The different meals tested (Oleic acid vs palmitic acid vs no lipid) will be given in a random way over the three visits. Before each of these three visits, a controlled diet will be established. At the last visit body composition and muscular strength will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Obesity
Keywords
Inflammatory response, High-fat meal, cytokines, Body composition

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mashed potatoes
Arm Type
Placebo Comparator
Arm Description
Mashed potatoes is composed of potatoes and Skim milk powder.
Arm Title
Mashed potatoes + Oleic Acid
Arm Type
Experimental
Arm Description
The test meal is mashed potatoes with 1g/Kg of weight of lipids with 75% of Oleic Acid
Arm Title
Mashed potatoes + Palmitic Acid
Arm Type
Experimental
Arm Description
The test meal is mashed potatoes with 1g/Kg of weight of lipids with 39% of saturated fat with 32% of palmitic acid.
Intervention Type
Other
Intervention Name(s)
Mashed potatoes
Intervention Description
Mashed potatoes: Potatoes + Skim milk powder
Intervention Type
Other
Intervention Name(s)
Mashed potatoes + Oleic acid
Intervention Description
Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid
Intervention Type
Other
Intervention Name(s)
mashed potatoes + Palmitic acid
Intervention Description
Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid
Primary Outcome Measure Information:
Title
Inflammatory profile by interleukin-6 (IL6) concentration in plasma.
Time Frame
six times per day (kinetic: T0 to T480) on three interventional days
Secondary Outcome Measure Information:
Title
Muscular strength, Body composition
Time Frame
Once at the first and at the last visit
Title
Total plasma lipids (total cholesterol, HDL-Cholesterol, LDL-cholesterol, Triglycerides (TG), non-esterified fatty acid, Plasma hormonal profile, Plasma inflammatory profile, Markers of Endothelial function, Plasma lipopolysaccharide concentration.
Time Frame
Six times per day (kinetic: T0 to T480), on three interventional days
Title
Pro-inflammatory cytokines expression in subcutaneous adipose tissue
Time Frame
Twice per day (before the meal and 6 hours after), on three interventional days
Title
Urinary metabolomic profile
Time Frame
Three times per days (T0,T240,T480), on three interventional days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject giving his written informed consent Male from 20 to 35 years old and more than 60 Affiliated to the French National Health Insurance Body mass index (BMI) ≤ 25kg/m² and waist circumference ≤94cm ; or BMI ≥ 28kg/m² and waist circumference ≥ 102cm. Complete blood count (CBC)-platelet, normal liver function and normal coagulation. Serology of Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) negative normal Thyroid Stimulating Hormone(TSH) Exclusion Criteria: Previous medical and/or surgery judged by the investigator as incompatible with this study Glaucoma C-reactive protein > 10 mg/l people over 120 kg People with triglyceridemia > 3 g/L or with familial hypercholesterolemia Fasting glycemia > 1,26 g/l, abnormal Oral Glucose Tolerance Test Dietary habits judged by the dietitian as incompatible with the study aim Vegetarians Nutritional allergies or xylocaïn allergy People with eating disorders Heavy consumer of alcohol or cigarette Practising intensive physical exercise People with medication that could interfere with the measured parameters: beta-blockers, statins, anticoagulants, antiplatelet agents, corticosteroids for more than 8 days. Depression or psychiatric treatment Being under someone's supervision Refusal to be registered on the National Volunteers Data file or refusal to sign the consent form Being in exclusion on the National Volunteers Data file Blood donation into the last two months preceding the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Boirie, MD/PhD
Organizational Affiliation
CRNH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephane Walrand, PhD
Organizational Affiliation
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Official's Role
Study Director
Facility Information:
Facility Name
Human nutrition laboratory
City
Clermont-ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.inra.fr
Description
Related Info

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Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age

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