ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
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Purpose
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 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 not only on the components of MetS but also on colon carcinogenesis, inflammation and immune function in the gut. The investigators have special interest in the combination of two types of fibres (Resistent starch (RS) and Arabinoxylans (AX)).
| Condition | Intervention |
|---|---|
|
Metabolic Syndrome |
Dietary Supplement: Western Style Diet Dietary Supplement: Healthy Carbohydrate Diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome |
- Activation of T-cells in mucosa described by reduced expression of CD25 and CD56. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
- A change in gut microbiome evaluated by 16 S-RNA analysis [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
- Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
- Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17). [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
- Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-β). [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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, high blood lipids, high blood pressure and 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 not only on the components of MetS but also on colon carcinogenesis, inflammation and immune function in the gut. The investigators have special interest in the combination of two types of fibres (Resistent starch (RS) and Arabinoxylans (AX)).
Hypotheses: Increase of RS and AX in the food with an increased colonic butyrate concentration influence and change the mucosal immune system - estimated by flow cytometry of mononuclear cells and dendritic cells in biopsies from the colon and by flow cytometry of peripheral blood mononuclear cells.
Furthermore, the investigators are looking for the impact of a changed level of butyrate on the microbiome adjacent to the colonic epithelium.
Through an analysis for changes in gene expression of selected genes involved in inflammation, immune function and oncogenesis the investigators want to see how a change in butyrate concentration in colon might change colonic health. The mechanistic way a changed butyrate concentration could change the gene expression of genes involved in the immune function, wound healing and oncogenesis.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01618526 History of Changes |
| Other Study ID Numbers: | V02062012 |
| Study First Received: | May 30, 2012 |
| Last Updated: | January 23, 2013 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by University of Aarhus:
|
Dietary fibers Butyrate Short Chain Fatty Acids Colon Metabolic Syndrome |
Additional relevant MeSH terms:
|
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013