- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- Michigan Clincal Research Unit
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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%
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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.
|
|
Övrig: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Insulin Sensitivity
Tidsram: 2-3 hours
|
A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity.
|
2-3 hours
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Vilande ämnesomsättning
Tidsram: 20-30 min
|
20-30 min
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Jeffrey F Horowitz, Ph.D., University of Michigan
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N009310
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