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

Aarhus University Hospital

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01584427

CERN-ButCoIns

Details and patient eligibility

About

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.

Full 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

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups, including a placebo group

Healthy Carbohydrate Diet

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet

Western Style Diet

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet