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

Study Overview
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Brief Summary
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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
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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: a western style diet, WSD, with a low fiber content and 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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Western Style Diet
* Dietary Supplement: Healthy Carbohydrate Diet


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Carbohydrate Diet<br>4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch | Dietary Supplement: Healthy Carbohydrate Diet<br>* Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers ( Arabinoxylans and Resistent Starch) compared with Western Style Diet with low content of dietary fibers<br>|
| Placebo Comparator: Western Style Diet<br>4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans. | Dietary Supplement: Western Style Diet<br>* Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers (Arabinoxylans and Resist Starch) compared with a Western Style Diet with a low content of dietary fibers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feces-short chain fatty acids | Concentration of short chain fatty acids | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary fibers, Butyrate, Short Chain Fatty Acids, Colon, Metabolic Syndrome