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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Institut National de la Recherche Agronomique.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Centre de Recherche en Nutrition Humaine d'Auvergne
ITERG
Information provided by:
Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier:
NCT01066091
First received: February 9, 2010
Last updated: September 24, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Healthy
Obesity
Other: Mashed potatoes
Other: Mashed potatoes + Oleic acid
Other: mashed potatoes + Palmitic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age

Resource links provided by NLM:


Further study details as provided by Institut National de la Recherche Agronomique:

Primary Outcome Measures:
  • Inflammatory profile by interleukin-6 (IL6) concentration in plasma. [ Time Frame: six times per day (kinetic: T0 to T480) on three interventional days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscular strength, Body composition [ Time Frame: Once at the first and at the last visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pro-inflammatory cytokines expression in subcutaneous adipose tissue [ Time Frame: Twice per day (before the meal and 6 hours after), on three interventional days ] [ Designated as safety issue: No ]
  • Urinary metabolomic profile [ Time Frame: Three times per days (T0,T240,T480), on three interventional days ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: March 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066091

Locations
France
Human nutrition laboratory
Clermont-ferrand, Auvergne, France, 63000
Sponsors and Collaborators
Institut National de la Recherche Agronomique
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
  More Information

Additional Information:
No publications provided

Responsible Party: Pr Yves Boirie, INRA
ClinicalTrials.gov Identifier: NCT01066091     History of Changes
Other Study ID Numbers: AU800, IDRCB 2009-A00322-55, 05/2009 SWALRAND
Study First Received: February 9, 2010
Last Updated: September 24, 2010
Health Authority: France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ministry of Health

Keywords provided by Institut National de la Recherche Agronomique:
Inflammatory response
High-fat meal
cytokines
Body composition

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Palmitic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014