Clinical trial NCT01618526: ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Official title: ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Dietary fibers
Butyrate
Short Chain Fatty Acids
Colon
Metabolic Syndrome
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2012-06-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feces-short chain fatty acids
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: A change in gut microbiome evaluated by 16 S-RNA analysis
timeFrame: Baseline and 4 weeks
measure: Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis.
timeFrame: Baseline and 4 weeks
measure: Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17).
timeFrame: Baseline and 4 weeks
measure: Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-β).
timeFrame: Baseline and 4 weeks
measure: Activation of T-cells in mucosa described by reduced expression of CD25 and CD69.
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: Aarhus University, Department of Animal Sciens
name: Knud Erik Bach Knudsen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hald S, Schioldan AG, Moore ME, Dige A, Laerke HN, Agnholt J, Bach Knudsen KE, Hermansen K, Marco ML, Gregersen S, Dahlerup JF. Effects of Arabinoxylan and Resistant Starch on Intestinal Microbiota and Short-Chain Fatty Acids in Subjects with Metabolic Syndrome: A Randomised Crossover Study. PLoS One. 2016 Jul 19;11(7):e0159223. doi: 10.1371/journal.pone.0159223. eCollection 2016.