Clinical trial NCT01066091: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Obesity
Keywords: Inflammatory response
High-fat meal
cytokines
Body composition
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Nutrition Humaine d'Auvergne
name: ITERG
First posted: 2010-02-10
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Inflammatory profile by interleukin-6 (IL6) concentration in plasma.
timeFrame: six times per day (kinetic: T0 to T480) on three interventional days
Secondary outcomes:
measure: Muscular strength, Body composition
timeFrame: Once at the first and at the last visit
measure: 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.
timeFrame: Six times per day (kinetic: T0 to T480), on three interventional days
measure: Pro-inflammatory cytokines expression in subcutaneous adipose tissue
timeFrame: Twice per day (before the meal and 6 hours after), on three interventional days
measure: Urinary metabolomic profile
timeFrame: Three times per days (T0,T240,T480), on three interventional days
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: Human nutrition laboratory
state: Auvergne
Study officials:
affiliation: CRNH
name: Yves Boirie, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Stephane Walrand, PhD
role: STUDY_DIRECTOR
References: