ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Healthy Carbohydrate Diet vs. Western Style Diet
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dietary fibers; Resistent Starch; Arabinoxylans; Postprandial lipaemia; Insulin sensitivity; Body composition; Gene expression; Metabolic rate; Blood pressure