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

NCT ID: NCT01584427

Last Updated: 2013-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-04-30

Brief 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

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Carbohydrate Diet

4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.

Group Type: ACTIVE_COMPARATOR

Healthy Carbohydrate Diet vs. Western Style Diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Western Style Diet

4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans

Group Type: PLACEBO_COMPARATOR

Healthy Carbohydrate Diet vs. Western Style Diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

AnneMarie Kruse

Professor Kjeld Hermansen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aarhus University Hospital

Aarhus, Aarhus, Denmark

Countries

Denmark

Other Identifiers

CERN-ButCoIns

Identifier Type: -

Identifier Source: org_study_id