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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Healthy Carbohydrate Diet vs. Western Style Diet
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Dietary fibers, Resistent Starch, Arabinoxylans, Postprandial lipaemia, Insulin sensitivity, Body composition, Gene expression, Metabolic rate, Blood pressure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Healthy Carbohydrate Diet

Western Style Diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in insulin sensitivity
-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
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
H-MRS of liver before and after intervention in order to estimate the fat content.
Twenty-Four-Hour Blood Pressure
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
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
hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.

Full Information

First Posted
April 20, 2012
Last Updated
June 6, 2013
Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01584427
Brief Title
ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Acronym
ButCoIns
Official Title
ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Dietary fibers, Resistent Starch, Arabinoxylans, Postprandial lipaemia, Insulin sensitivity, Body composition, Gene expression, Metabolic rate, Blood pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Carbohydrate Diet
Arm Type
Active Comparator
Arm Description
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.
Arm Title
Western Style Diet
Arm Type
Placebo Comparator
Arm Description
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans
Intervention Type
Dietary Supplement
Intervention Name(s)
Healthy Carbohydrate Diet vs. Western Style Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postprandial triglycerides
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in insulin sensitivity
Description
-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.
Time Frame
4 weeks
Title
Metabolic Rate
Description
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.
Time Frame
4 weeks
Title
Body composition
Description
H-MRS of liver before and after intervention in order to estimate the fat content.
Time Frame
4 weeks
Title
Twenty-Four-Hour Blood Pressure
Description
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.
Time Frame
4 weeks
Title
Gene expression in adipose tissue
Description
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.
Time Frame
Four weeks
Title
Inflammatory Markers after 4 weeks of intervention
Description
hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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