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

NCT01584427 | Completed DMC

• 1 other identifier: CERN-ButCoIns
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Dietary fibers; Resistent Starch; Arabinoxylans; Postprandial lipaemia; Insulin sensitivity; Body composition; Gene expression; Metabolic rate; Blood pressure

Outcome Measures

Primary Outcomes (1)

• Postprandial triglycerides

  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.

  4 weeks

Secondary Outcomes (6)

• Change in insulin sensitivity

  4 weeks

• Metabolic Rate

  4 weeks

• Body composition

  4 weeks

• Twenty-Four-Hour Blood Pressure

  4 weeks

• Gene expression in adipose tissue

  Four weeks

Study Arms (2)

Healthy Carbohydrate Diet

ACTIVE COMPARATOR

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

Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet

Western Style Diet

PLACEBO COMPARATOR

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

Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet

Interventions

Healthy Carbohydrate Diet vs. Western Style Diet 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.

Healthy Carbohydrate Diet; Western Style Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Kjeld Hermansen

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 25, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

DK (1)