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

NCT01066091 | Completed

• 3 other identifiers: AU800IDRCB 2009-A00322-5505/2009 SWALRAND
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Obesity

Keywords

Inflammatory response; High-fat meal; cytokines; Body composition

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

• 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

Study Arms (3)

mashed potatoes

PLACEBO COMPARATOR

Mashed potatoes is composed of potatoes and Skim milk powder.

Other: Mashed potatoes

Mashed potatoes + Oleic Acid

EXPERIMENTAL

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 + Palmitic Acid

EXPERIMENTAL

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

Interventions

Mashed potatoes OTHER

Mashed potatoes: Potatoes + Skim milk powder

mashed potatoes

Mashed potatoes + Oleic acid OTHER

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

Mashed potatoes + Oleic Acid

mashed potatoes + Palmitic acid OTHER

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

Mashed potatoes + Palmitic Acid

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yves Boirie: lead
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator
• ITERG: collaborator

Study Sites (1)

Human nutrition laboratory

Clermont-Ferrand, Auvergne, 63000, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity

Interventions

Oleic Acid; Palmitic Acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oleic Acids; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Palmitic Acids

Study Officials

• Yves Boirie, MD/PhD

  CRNH

  PRINCIPAL INVESTIGATOR

• Stephane Walrand, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Pr Yves Boirie

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 25, 2015

Record last verified: 2011-01

Locations

FR (1)