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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618526
• Other study ID #: V02062012
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: May 28, 2015
• Start date: April 2012
• Est. completion date: May 2015

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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.
• 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

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feces-short chain fatty acids	Concentration of short chain fatty acids	Baseline and 4 weeks	No
Secondary	A change in gut microbiome evaluated by 16 S-RNA analysis		Baseline and 4 weeks	No
Secondary	Change in Nuclear Factor-kappa B (NF-?B) described by gene expression analysis.		Baseline and 4 weeks	No
Secondary	Change in production of pro inflammatory cytokines on mucosal level (IFN-?, TNF-a, IL-17).		Baseline and 4 weeks	No
Secondary	Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-ß).		Baseline and 4 weeks	No
Secondary	Activation of T-cells in mucosa described by reduced expression of CD25 and CD69.		Baseline and 4 weeks	No