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ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome (ButCoIns)

6. juni 2013 opdateret af: AnneMarie Kruse, Aarhus University Hospital

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Aarhus, Danmark, 8000
        • Aarhus University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Healthy Carbohydrate Diet
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.
Kosttilskud: Healthy Carbohydrate Diet vs. Western Style Diet
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.
Placebo komparator: Western Style Diet
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans
Kosttilskud: Healthy Carbohydrate Diet vs. Western Style Diet
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postprandial triglycerides
Tidsramme: 4 weeks
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.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
4 weeks
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.
4 weeks
Body composition
Tidsramme: 4 weeks
H-MRS of liver before and after intervention in order to estimate the fat content.
4 weeks
Twenty-Four-Hour Blood Pressure
Tidsramme: 4 weeks
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.
4 weeks
Gene expression in adipose tissue
Tidsramme: Four weeks
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.
Four weeks
Inflammatory Markers after 4 weeks of intervention
Tidsramme: 4 weeks
hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Aarhus University Hospital

Samarbejdspartnere

University of Aarhus

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2012

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

20. april 2012

Først indsendt, der opfyldte QC-kriterier

24. april 2012

Først opslået (Skøn)

25. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CERN-ButCoIns

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Metabolisk syndrom

Kliniske forsøg med Healthy Carbohydrate Diet vs. Western Style Diet

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Canada

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner