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

Not Applicable

Completed

• Conditions: Healthy; Obesity
• Interventions: Other: mashed potatoes + Palmitic acid; Other: Mashed potatoes; Other: Mashed potatoes + Oleic acid

• Registration Number: NCT01066091
• Lead Sponsor: Yves Boirie

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.

Study Timeline

• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Study Start: 2010-03
• Primary Completion: 2010-12
• Status Verified: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mashed potatoes + Palmitic Acid	mashed potatoes + Palmitic acid	The test meal is mashed potatoes with 1g/Kg of weight of lipids with 39% of saturated fat with 32% of palmitic acid.
mashed potatoes	Mashed potatoes	Mashed potatoes is composed of potatoes and Skim milk powder.
Mashed potatoes + Oleic Acid	Mashed potatoes + Oleic acid	The test meal is mashed potatoes with 1g/Kg of weight of lipids with 75% of Oleic Acid

Primary Outcome Measures

Name	Time	Method
Inflammatory profile by interleukin-6 (IL6) concentration in plasma.	six times per day (kinetic: T0 to T480) on three interventional days

Secondary Outcome Measures

Name	Time	Method
Muscular strength, Body composition	Once at the first and at the last visit
Urinary metabolomic profile	Three times per days (T0,T240,T480), on three interventional days
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.	Six times per day (kinetic: T0 to T480), on three interventional days
Pro-inflammatory cytokines expression in subcutaneous adipose tissue	Twice per day (before the meal and 6 hours after), on three interventional days

Trial Locations

Locations (1)

Human nutrition laboratory; 🇫🇷 Clermont-ferrand, Auvergne, France