ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Healthy Carbohydrate Diet; Dietary supplement: Western Style Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feces-short chain fatty acids	Concentration of short chain fatty acids	Baseline and 4 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Knud Erik Bach Knudsen, Professor, Aarhus University, Department of Animal Sciens

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: June 11, 2012
• First Posted (Estimate): June 13, 2012

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; Colon; Short Chain Fatty Acids; Butyrate; Dietary fibers
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: V02062012