ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Healthy Carbohydrate Diet; Dietary Supplement: Western Style Diet

• Registration Number: NCT01618526
• Lead Sponsor: University of Aarhus

Brief Summary

Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.

In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are randomized to two types of diet intervention: a low and a high fiber diet. The participants are subjected to endoscopy before and in the end of each intervention.

Detailed Description

Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.

In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are subjected to two types of diet intervention:

1. a western style diet, WSD, with a low fiber content and

2. a healthy carbohydrate diet, HCD, a high fiber diet. Between the two 4-weeks diet is a wash-out period of four to eight weeks. The participants are subjected to endoscopy with tissue samples before and in the end of each intervention. Fecal and blood samples will be collected at the same time.

We hypothesize that a high content of resistent starch and arabinoxylans increases colonic butyrate concentration, changes colon's mucosal immune system and the microbiota.

A small pilot study will be carried out on 12 healthy volunteers in order to obtain a reference to participants with metabolic syndrome. The healthy volunteers will be subjected to an endoscopy but no dietary intervention.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-13
• Status Verified: 2013-08
• Primary Completion: 2013-12
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

At least 3 out of 5 following criteria:

• Central obesity (Female > 80 cm, Male > 94 cm)
• HDL cholesterol (Female < 1,03 mmol/L, Male < 1,29 mmol/L)
• Bloodpressure (> 130/85 mmHg)
• Fasting Blood Glucose > 5,6 mmol/L

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Exclusion Criteria

• Diabetes
• Gastrointestinal disease
• Serious liver, heart or kidney disease
• Anticoagulation treatment
• Anaemia
• Corticosteroid treatment
• Waist circumference above 130 cm
• Alcohol or drug addiction
• Pregnancy or lactation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy Carbohydrate Diet	Healthy Carbohydrate Diet	4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch
Western Style Diet	Western Style Diet	4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans.

Primary Outcome Measures

Name	Time	Method
Feces-short chain fatty acids	Baseline and 4 weeks	Concentration of short chain fatty acids

Secondary Outcome Measures

Name	Time	Method
Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17).	Baseline and 4 weeks
Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-β).	Baseline and 4 weeks
Activation of T-cells in mucosa described by reduced expression of CD25 and CD69.	Baseline and 4 weeks
A change in gut microbiome evaluated by 16 S-RNA analysis	Baseline and 4 weeks
Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis.	Baseline and 4 weeks

Trial Locations

Locations (1)

Aarhus University; 🇩🇰 Aarhus, Denmark