- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Auvergne
-
Clermont-ferrand, Auvergne, Francia, 63000
- Human Nutrition Laboratory
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: mashed potatoes
Mashed potatoes is composed of potatoes and Skim milk powder.
|
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
|
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.
|
Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Inflammatory profile by interleukin-6 (IL6) concentration in plasma.
Periodo de tiempo: six times per day (kinetic: T0 to T480) on three interventional days
|
six times per day (kinetic: T0 to T480) on three interventional days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Muscular strength, Body composition
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Three times per days (T0,T240,T480), on three interventional days
|
Three times per days (T0,T240,T480), on three interventional days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yves Boirie, MD/PhD, CRNH
- Director de estudio: Stephane Walrand, PhD, Institut National de la Recherche Agronomique
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AU800
- IDRCB 2009-A00322-55 (Identificador de registro: Afssaps)
- 05/2009 SWALRAND (Otro identificador: CRNH)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .