Metabolism Associated With Abdominal Fat Mass Distribution
Objectives:
The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat).
No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Lausanne, Sveits, 1011
- University Hospitals, Service of endocrinology, diabetology, and metabolism
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Lausanne 26, Sveits, 1000
- Nestlé Clinical Development Unit / Metabolic Unit
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- BMI 29-40 kg/m2
- Aged 25-45
Exclusion Criteria:
- Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease, metabolic syndrome
- Pregnancy
- Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study.
- Any therapy (contraception apart) within the run-in period of one week before the test day.
- Subject who cannot be expected to comply with treatments and measures.
- Subject who is affected by any specific eating disorder
- Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- Subjects having recently undergone a weight loss of more than 3 kilos during the last 3 months
Studieplan
Hvordan er studiet utformet?
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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No product is tested
No intervention
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Metabolic plasma, urine and faeces profiles as a function of fat mass distribution
Tidsramme: Changes from baseline in metabolic profiles at one day following fat meal intake
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Metabolic profiles of plasma, urine and feces samples are obtained by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry. Fat mass distribution is assessed using CT scan and DXA (Dual X-Ray Energy Absorptiometry). |
Changes from baseline in metabolic profiles at one day following fat meal intake
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Insulin sensitivity
Tidsramme: Measured on the day before the fat meal intake
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Insulin sensitivity is measured by oral glucose tolerance test
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Measured on the day before the fat meal intake
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|
Basal Energy Expenditure
Tidsramme: Basal Energy Expenditure is measured on the day preceding the fat meal intake
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Basal Energy Expenditure is measured by indirect calorimetry
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Basal Energy Expenditure is measured on the day preceding the fat meal intake
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Vittorio Giusti, MD, PD/MER, University Hospitals of Lausanne
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 (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 08.02.NRC
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