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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

University of Aarhus

Information provided by (Responsible Party):

AnneMarie Kruse, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT01584427

First received: April 20, 2012

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	April 20, 2012
Last Updated Date	January 23, 2013
Start Date ^ICMJE	April 2012
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 24, 2012)	Postprandial triglycerides [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01584427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 23, 2013)	Change in insulin sensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] -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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] H-MRS of liver before and after intervention in order to estimate the fat content. Twenty-Four-Hour Blood Pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] 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 [ Time Frame: Four weeks ] [ Designated as safety issue: No ] 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.
Original Secondary Outcome Measures ^ICMJE (submitted: April 24, 2012)	Change in Insulin sensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] -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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] The metabolic rate is meassured 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] H-MRS of liver and muscel before and after intervention in order to estimate the fat content. Twenty-Four-Hour Blood Pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Performed in the free-living situation. Data analysis are grouped in mean day, mean night and mean 24 h. Meassured at baseline and at the end of each intervention. Gene expression in adipose tissue [ Time Frame: Four weeks ] [ Designated as safety issue: No ] Fat biopsies are take from abdominal adipose tissue and analysed by real time PCR to see if geneexpression changes after a high intake of dietary fiber. Inflammatory Markers after 4 weeks of intervention [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] hs CRP, IL-6 and adiponectin are meassured at baseline and at the end of each intervention.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Official Title ^ICMJE	ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome
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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Metabolic Syndrome
Intervention ^ICMJE	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.
Study Arm (s)	Active Comparator: Healthy Carbohydrate Diet 4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch. Intervention: Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet Placebo Comparator: Western Style Diet 4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans Intervention: Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	22
Estimated Completion Date	April 2015
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01584427
Other Study ID Numbers ^ICMJE	CERN-ButCoIns
Has Data Monitoring Committee	Yes
Responsible Party	AnneMarie Kruse, Aarhus University Hospital
Study Sponsor ^ICMJE	Aarhus University Hospital
Collaborators ^ICMJE	University of Aarhus
Investigators ^ICMJE	Not Provided
Information Provided By	Aarhus University Hospital
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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