Metabolic Syndrome
Conditions
Keywords
Dietary fibers, Butyrate, Short Chain Fatty Acids, Colon, Metabolic Syndrome
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.
Interventions
DIETARY_SUPPLEMENTWestern 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.
DIETARY_SUPPLEMENTHealthy 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
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feces-short chain fatty acids | Baseline and 4 weeks | Concentration of short chain fatty acids |
Secondary
| Measure | 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 |
Countries
Denmark
Outcome results
None listed