ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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:
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a western style diet, WSD, with a low fiber content and
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Healthy Carbohydrate Diet 4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch |
Dietary Supplement: Healthy Carbohydrate Diet
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
|
| Placebo Comparator: Western Style Diet 4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans. |
Dietary Supplement: Western Style Diet
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.
|
Outcome Measures
Primary Outcome Measures
- Feces-short chain fatty acids [Baseline and 4 weeks]
Concentration of short chain fatty acids
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria: At least 3 out of 5 following criteria:
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Central obesity (Female > 80 cm, Male > 94 cm)
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HDL cholesterol (Female < 1,03 mmol/L, Male < 1,29 mmol/L)
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Bloodpressure (> 130/85 mmHg)
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Fasting Blood Glucose > 5,6 mmol/L
Exclusion Criteria:
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Diabetes
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Gastrointestinal disease
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Serious liver, heart or kidney disease
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Anticoagulation treatment
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Anaemia
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Corticosteroid treatment
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Waist circumference above 130 cm
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Alcohol or drug addiction
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Pregnancy or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aarhus University | Aarhus | Denmark | 8000 |
Sponsors and Collaborators
- University of Aarhus
- Aarhus University Hospital
Investigators
- Principal Investigator: Knud Erik Bach Knudsen, Professor, Aarhus University, Department of Animal Sciens
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V02062012