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Completed

NCT Number: NCT01066091

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.

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Key information

Age range

20 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Human nutrition laboratory

Clermont-Ferrand, Auvergne, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mashed potatoes

Other

Mashed potatoes: Potatoes + Skim milk powder

Mashed potatoes + Oleic acid

Other

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

mashed potatoes + Palmitic acid

Other

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

Primary outcomes

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

    Time frame: six times per day (kinetic: T0 to T480) on three interventional days

Secondary outcomes

  1. Muscular strength, Body composition

    Time frame: Once at the first and at the last visit

  2. 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

  3. Pro-inflammatory cytokines expression in subcutaneous adipose tissue

    Time frame: Twice per day (before the meal and 6 hours after), on three interventional days

  4. Urinary metabolomic profile

    Time frame: Three times per days (T0,T240,T480), on three interventional days

Sponsors and collaborators

Lead sponsor

Yves Boirie

Other

Collaborators

  • Centre de Recherche en Nutrition Humaine d'Auvergne
  • ITERG

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Feb 10, 2010
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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