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

24. marts 2015 opdateret af: Yves Boirie

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: mashed potatoes
Mashed potatoes is composed of potatoes and Skim milk powder.
Andet: Mashed potatoes
Mashed potatoes: Potatoes + Skim milk powder
Eksperimentel: Mashed potatoes + Oleic Acid
The test meal is mashed potatoes with 1g/Kg of weight of lipids with 75% of Oleic Acid
Andet: Mashed potatoes + Oleic acid
Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid
Eksperimentel: 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.
Andet: mashed potatoes + Palmitic acid
Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Muscular strength, Body composition
Tidsramme: Once at the first and at the last visit
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.
Tidsramme: Six times per day (kinetic: T0 to T480), on three interventional days
Six times per day (kinetic: T0 to T480), on three interventional days
Pro-inflammatory cytokines expression in subcutaneous adipose tissue
Tidsramme: Twice per day (before the meal and 6 hours after), on three interventional days
Twice per day (before the meal and 6 hours after), on three interventional days
Urinary metabolomic profile
Tidsramme: Three times per days (T0,T240,T480), on three interventional days
Three times per days (T0,T240,T480), on three interventional days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yves Boirie

Samarbejdspartnere

Centre de Recherche en Nutrition Humaine d'Auvergne
ITERG

Efterforskere

  • Ledende efterforsker: Yves Boirie, MD/PhD, CRNH
  • Studieleder: Stephane Walrand, PhD, Institut National de la Recherche Agronomique

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2010

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først indsendt

9. februar 2010

Først indsendt, der opfyldte QC-kriterier

9. februar 2010

Først opslået (Skøn)

10. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2015

Sidst verificeret

1. januar 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AU800
  • IDRCB 2009-A00322-55 (Registry Identifier: Afssaps)
  • 05/2009 SWALRAND (Anden identifikator: CRNH)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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