- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
Auvergne
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Clermont-ferrand, Auvergne, Frankreich, 63000
- Human Nutrition Laboratory
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Placebo-Komparator: mashed potatoes
Mashed potatoes is composed of potatoes and Skim milk powder.
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Mashed potatoes: Potatoes + Skim milk powder
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Experimental: Mashed potatoes + Oleic Acid
The test meal is mashed potatoes with 1g/Kg of weight of lipids with 75% of Oleic Acid
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Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid
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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.
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Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Inflammatory profile by interleukin-6 (IL6) concentration in plasma.
Zeitfenster: six times per day (kinetic: T0 to T480) on three interventional days
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six times per day (kinetic: T0 to T480) on three interventional days
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Muscular strength, Body composition
Zeitfenster: Once at the first and at the last visit
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Once at the first and at the last visit
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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.
Zeitfenster: Six times per day (kinetic: T0 to T480), on three interventional days
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Six times per day (kinetic: T0 to T480), on three interventional days
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Pro-inflammatory cytokines expression in subcutaneous adipose tissue
Zeitfenster: Twice per day (before the meal and 6 hours after), on three interventional days
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Twice per day (before the meal and 6 hours after), on three interventional days
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Urinary metabolomic profile
Zeitfenster: Three times per days (T0,T240,T480), on three interventional days
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Three times per days (T0,T240,T480), on three interventional days
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Yves Boirie, MD/PhD, CRNH
- Studienleiter: Stephane Walrand, PhD, Institut National de la Recherche Agronomique
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AU800
- IDRCB 2009-A00322-55 (Registrierungskennung: Afssaps)
- 05/2009 SWALRAND (Andere Kennung: CRNH)
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