ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Feces-short chain fatty acids
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- 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
- •Gastrointestinal disease
- •Serious liver, heart or kidney disease
- •Anticoagulation treatment
- •Corticosteroid treatment
- •Waist circumference above 130 cm
- •Alcohol or drug addiction
- •Pregnancy or lactation
Arms & Interventions
Healthy Carbohydrate Diet
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch
Intervention: Healthy Carbohydrate Diet (Dietary Supplement)
Western Style Diet
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans.
Intervention: Western Style Diet (Dietary Supplement)
Outcomes
Primary Outcomes
Feces-short chain fatty acids
Time Frame: Baseline and 4 weeks
Concentration of short chain fatty acids
Secondary Outcomes
- 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)