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

6 juni 2013 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

22

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Healthy Carbohydrate Diet
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.
Kosttillskott: 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-jämförare: Western Style Diet
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans
Kosttillskott: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postprandial triglycerides
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in insulin sensitivity
Tidsram: 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
Tidsram: 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
Tidsram: 4 weeks
H-MRS of liver before and after intervention in order to estimate the fat content.
4 weeks
Twenty-Four-Hour Blood Pressure
Tidsram: 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
Tidsram: 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
Tidsram: 4 weeks
hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.
4 weeks

Samarbetspartners och utredare

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Sponsor

Aarhus University Hospital

Samarbetspartners

University of Aarhus

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2012

Primärt slutförande (Faktisk)

1 april 2013

Avslutad studie (Faktisk)

1 april 2013

Studieregistreringsdatum

Först inskickad

20 april 2012

Först inskickad som uppfyllde QC-kriterierna

24 april 2012

Första postat (Uppskatta)

25 april 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

7 juni 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juni 2013

Senast verifierad

1 juni 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CERN-ButCoIns

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