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Completed

NCT Number: NCT01584427

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Postprandial triglycerides

    Time frame: 4 weeks

    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 outcomes

  1. Change in insulin sensitivity

    Time frame: 4 weeks

    -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.

  2. Metabolic Rate

    Time frame: 4 weeks

    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.

  3. Body composition

    Time frame: 4 weeks

    H-MRS of liver before and after intervention in order to estimate the fat content.

  4. Twenty-Four-Hour Blood Pressure

    Time frame: 4 weeks

    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.

  5. Gene expression in adipose tissue

    Time frame: Four weeks

    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.

  6. Inflammatory Markers after 4 weeks of intervention

    Time frame: 4 weeks

    hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University of Aarhus

Registry information

Acronym: ButCoIns

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2012
Registry last updated
Jun 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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