Clinical trial NCT01584427: ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Official title: ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Dietary fibers
Resistent Starch
Arabinoxylans
Postprandial lipaemia
Insulin sensitivity
Body composition
Gene expression
Metabolic rate
Blood pressure
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2012-04-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Postprandial triglycerides
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in insulin sensitivity
timeFrame: 4 weeks
measure: Metabolic Rate
timeFrame: 4 weeks
measure: Body composition
timeFrame: 4 weeks
measure: Twenty-Four-Hour Blood Pressure
timeFrame: 4 weeks
measure: Gene expression in adipose tissue
timeFrame: Four weeks
measure: Inflammatory Markers after 4 weeks of intervention
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: