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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Obesity
• Intervention / Treatment: Other: Mashed potatoes; Other: Mashed potatoes + Oleic acid; Other: mashed potatoes + Palmitic acid

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-ferrand, Auvergne, France, 63000
      • Human Nutrition Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: mashed potatoes; Mashed potatoes is composed of potatoes and Skim milk powder.	Other: Mashed potatoes; Mashed potatoes: Potatoes + Skim milk powder
Experimental: Mashed potatoes + Oleic Acid; The test meal is mashed potatoes with 1g/Kg of weight of lipids with 75% of Oleic Acid	Other: Mashed potatoes + Oleic acid; Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid
Experimental: 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.	Other: mashed potatoes + Palmitic acid; Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Muscular strength, Body composition	Once at the first and at the last visit
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
Urinary metabolomic profile	Three times per days (T0,T240,T480), on three interventional days

Collaborators and Investigators

• Sponsor: Yves Boirie
• Collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne; ITERG
• Investigators: Principal Investigator: Yves Boirie, MD/PhD, CRNH; Study Director: Stephane Walrand, PhD, Institut National de la Recherche Agronomique

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 10, 2010

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Body composition; cytokines; Inflammatory response; High-fat meal
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Palmitic Acid
• Other Study ID Numbers: AU800; IDRCB 2009-A00322-55 (Registry Identifier: Afssaps); 05/2009 SWALRAND (Other Identifier: CRNH)