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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01584427
Acronym
ButCoIns
Enrollment
22
Registered
2012-04-25
Start date
2012-04-30
Completion date
2013-04-30
Last updated
2013-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

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

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

Interventions

DIETARY_SUPPLEMENTHealthy 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.

Sponsors

University of Aarhus
CollaboratorOTHER
Aarhus University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial triglycerides4 weeksPlasma 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

MeasureTime frameDescription
Metabolic Rate4 weeksThe 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 composition4 weeksH-MRS of liver before and after intervention in order to estimate the fat content.
Change in insulin sensitivity4 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.
Gene expression in adipose tissueFour weeksFat 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 intervention4 weekshs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.
Twenty-Four-Hour Blood Pressure4 weeksPerformed 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026