- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01451970
Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities
Assessing the Effects of Two Diets Enriched in Either Saturated or Unsaturated Fatty Acids to Determine the Cellular and Molecular Mechanisms in Insulin Sensitivity
Individuals have a significant capacity to adapt to different environments by changing their core metabolic pathways. This adaptation is especially important in regards to diet. Epidemiological research over the last several decades have shown that diets high in saturated fats have a greater ability to cause insulin resistance and the 'metabolic syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces the risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats, as compared to high carbohydrate or high saturated fat diets, result in increased insulin sensitivity and improved lipid profiles.
In this application, the investigators propose to systematically assess the effects of two diets enriched in either saturated or unsaturated fatty acids and determine the cellular and molecular mechanisms of the apparent increase in insulin sensitivity. The investigators hypothesize that individuals will 'adapt' to the different diets and the investigators will be able to generate predictive alterations in gene expression and metabolites that underlie the alterations in metabolism. In parallel, the investigators will test the ability of these different diets to affect the release of gastrointestinal hormones that may be critical to modulation of appetite.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- Michigan Clincal Research Unit
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Premenopausal females with BMI range of 25-32 kg/m2
Exclusion Criteria:
- Evidence of metabolic or cardiovascular disease, Fasting plasma glucose concentration > 125mg/dl, Abnormal EKG, Hyperlipidemia (plasma triglyceride concentration > 150mg/dl), Pregnancy, Hematocrit <34%
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: High Monounsaturated Fat Diet
Subjects will adhere to their specific diet for four weeks.
The diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein.
For the monounsaturated fat treatment (M diet) approximately 10% of all lipids ingested will be saturated.
|
Subjects will adhere to their specific diet for four weeks.
For both diet treatments, the diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein.
For the monounsaturated fat treatment (M diet) approximately 10% of all lipids ingested will be saturated.
For the saturated fat treatment (S diet) approximately 40% of all lipids ingested will be saturated.
|
|
Autre: High Saturated Fat Diet
Subjects will adhere to their specific diet for four weeks.
The diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein.
For the saturated fat treatment (S diet) approximately 40% of all lipids ingested will be saturated.
|
Subjects will adhere to their specific diet for four weeks.
For both diet treatments, the diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein.
For the monounsaturated fat treatment (M diet) approximately 10% of all lipids ingested will be saturated.
For the saturated fat treatment (S diet) approximately 40% of all lipids ingested will be saturated.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Insulin Sensitivity
Délai: 2-3 hours
|
A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity.
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2-3 hours
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Taux métabolique au repos
Délai: 20-30 minutes
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20-30 minutes
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jeffrey F Horowitz, Ph.D., University of Michigan
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- N009310
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