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

Sponsor

Aarhus University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01584427

Collaborator

University of Aarhus (Other)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Healthy Carbohydrate Diet 4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.	Dietary Supplement: 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 Comparator: Western Style Diet 4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans	Dietary Supplement: 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.

Arm

Intervention/Treatment

Active Comparator: Healthy Carbohydrate Diet

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

Dietary Supplement: 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 Comparator: Western Style Diet

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

Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet

Outcome Measures

Primary Outcome Measures

Postprandial triglycerides [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.

Secondary Outcome Measures

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