- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Michigan Clincal Research Unit
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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.
|
|
Annen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Insulin Sensitivity
Tidsramme: 2-3 hours
|
A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity.
|
2-3 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Hvilende stoffskifte
Tidsramme: 20-30 min
|
20-30 min
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jeffrey F Horowitz, Ph.D., University of Michigan
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- N009310
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