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

This study has been completed.
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: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Dietary Supplement: Healthy Carbohydrate Diet vs. Western Style Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Carbohydrate Diet
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.
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.
Placebo Comparator: Western Style Diet
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584427

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
  More Information

No publications provided

Responsible Party: AnneMarie Kruse, Professor Kjeld Hermansen, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01584427     History of Changes
Other Study ID Numbers: CERN-ButCoIns
Study First Received: April 20, 2012
Last Updated: June 6, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital:
Dietary fibers
Resistent Starch
Arabinoxylans
Postprandial lipaemia
Insulin sensitivity
Body composition
Gene expression
Metabolic rate
Blood pressure

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014