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

NCT ID: NCT01066091

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-01-31

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.

Conditions

Healthy; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

mashed potatoes

Mashed potatoes is composed of potatoes and Skim milk powder.

Group Type: PLACEBO_COMPARATOR

Mashed potatoes

Intervention Type: OTHER

Mashed potatoes: Potatoes + Skim milk powder

Mashed potatoes + Oleic Acid

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

Group Type: EXPERIMENTAL

Mashed potatoes + Oleic acid

Intervention Type: OTHER

Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic 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.

Group Type: EXPERIMENTAL

mashed potatoes + Palmitic acid

Intervention Type: OTHER

Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid

Interventions

Mashed potatoes

Mashed potatoes: Potatoes + Skim milk powder

Intervention Type: OTHER

Mashed potatoes + Oleic acid

Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid

Intervention Type: OTHER

mashed potatoes + Palmitic acid

Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre de Recherche en Nutrition Humaine d'Auvergne

OTHER_GOV

Sponsor Role: collaborator

ITERG

INDUSTRY

Sponsor Role: collaborator

Yves Boirie

OTHER

Sponsor Role: lead

Responsible Party

Yves Boirie

MD, PhD, Pr Yves Boirie

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yves Boirie, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

CRNH

Stephane Walrand, PhD

Role: STUDY_DIRECTOR

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Locations

Human nutrition laboratory

Clermont-Ferrand, Auvergne, France

Countries

France

Related Links

http://www.inra.fr

Related Info

Other Identifiers

IDRCB 2009-A00322-55

Identifier Type: REGISTRY

Identifier Source: secondary_id

05/2009 SWALRAND

Identifier Type: OTHER

Identifier Source: secondary_id

AU800

Identifier Type: -

Identifier Source: org_study_id