- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01584427
ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome (ButCoIns)
Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and slightly elevated blood sugar. Subjects with MetS have high risk of developing Type 2 Diabetes and cardiovascular disease.
Dietary fibers have been shown to have positive effects on the components of MetS. The investigators have special interest in the combination of two types of fiber (Resistant (RS) starch and Arabinoxylans (AX)) .
Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases blood lipids, improves blood sugar, blood pressure and markers of inflammation.
The subjects undergo two dietary interventions of 4 weeks duration each: A "Healthy Carbohydrate Diet" with a high content of RS and AX is compared to a "Western Style Diet" with a low content of RS and AX.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, dyslipidemia, hypertension and impaired glucose tolerance. Subjects with MetS have high risk of developing Type 2 Diabetes and CVD.
Resistant Starch (RS) and Arabinoxylans (AX) are dietary fibers that have been shown to have positive effects on the components of MetS. The combination of RS and AX has not been tested before .
Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases postprandial lipaemia, improves glucose tolerance, insulin resistance, blood pressure and markers of inflammation.
Design:
A nonblinded randomized cross over study Two dietary interventions of 4 weeks duration each. A healthy carbohydrate Diet with a high content of RS and AX is compared to a Western Style diet with a low content of RS and AX. Between the two interventions, there is a wash out period of 4 weeks.
The primary outcome is postprandial lipaemia estimated by a high fat meal test of 6 hours duration. The test is performed before and after each intervention.
Secondary outcomes are:
- Glucose tolerance and insulin resistance estimated by OGTT
- 24 hours blood pressure
- MRI estimation of liver fat content
- Postprandial changes in genes of adipose tissue
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Aarhus, Danmark, 8000
- Aarhus University Hospital
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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: At least 3 out of the 5 following criterions
- Central obesity (Female >80 cm, Male >94)
- HDL cholesterol (female < 1,03 mmol/l, male < 1,29 mmol/l)
- Blood Pressure (> 130/85)
- Fasting Blood Glucose > 5,6 mmol/L
Exclusion Criteria:
- Diabetes
- Gastrointestinal disease
- Anticoagulation treatment
- Serious liver, heart or kidney disease
- Anaemia
- Corticosteroid treatment
- Waist circumference above 130 cm
- Alcohol or drug addiction
- Pregnancy og lactation
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Healthy Carbohydrate Diet
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.
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Cross over study with two intervention diets.
Healthy Carbohydrate Diet with approximally 55 g of dietary fibers (arabinoxylan and resistant starch)compared with western style diet with low content of dietary fibers.
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Placebo komparator: Western Style Diet
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans
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Cross over study with two intervention diets.
Healthy Carbohydrate Diet with approximally 55 g of dietary fibers (arabinoxylan and resistant starch)compared with western style diet with low content of dietary fibers.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Postprandial triglycerides
Tidsramme: 4 weeks
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Plasma Triglycerides are estimated during a high fat meal test of 6 hours duration.
The test is performed before and after each intervention of 4 weeks.
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4 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in insulin sensitivity
Tidsramme: 4 weeks
|
-Estimated by an OGTT where glucose and insulin are measured several times and insulin sensitivity is estimated according to the Matsuda Index.
The test is performed before and after each intervention of 4 weeks.
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4 weeks
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Metabolic Rate
Tidsramme: 4 weeks
|
The metabolic rate is measured by indirect calometri (Deltatrac II) in the fasting state and two hours after ingestion of a fatty mixed meal.
The test is performed before and after each intervention period.
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4 weeks
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Body composition
Tidsramme: 4 weeks
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H-MRS of liver before and after intervention in order to estimate the fat content.
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4 weeks
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Twenty-Four-Hour Blood Pressure
Tidsramme: 4 weeks
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Performed in the free-living situation.
Data analysis are grouped in mean day, mean night and mean 24 h.
Measured at baseline and at the end of each intervention.
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4 weeks
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Gene expression in adipose tissue
Tidsramme: Four weeks
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Fat biopsies are take from abdominal adipose tissue and analyzed by real time PCR to see if gene expression changes after a high intake of dietary fiber.
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Four weeks
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Inflammatory Markers after 4 weeks of intervention
Tidsramme: 4 weeks
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hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.
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4 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CERN-ButCoIns
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