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

This study is currently recruiting participants.
Verified August 2013 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01618526
First received: May 30, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Dietary Supplement: Western Style Diet
Dietary Supplement: Healthy Carbohydrate Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Feces-short chain fatty acids [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    Concentration of short chain fatty acids


Secondary Outcome Measures:
  • A change in gut microbiome evaluated by 16 S-RNA analysis [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17). [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-β). [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Activation of T-cells in mucosa described by reduced expression of CD25 and CD69. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: April 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618526

Contacts
Contact: Stine Hald, MD +45 61702344 stinhald@rm.dk

Locations
Denmark
Aarhus University Recruiting
Aarhus, Denmark, 8000
Contact: Stine Hald, MD    +45 61702344    stinhald@rm.dk   
Contact: Jens Frederik Dahlerup, Doctorate       jensdahl@rm.dk   
Sub-Investigator: Stine Hald, MD         
Principal Investigator: Jens Frederik Dahlerup, Doctorate         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Knud Erik Bach Knudsen, Professor Aarhus University, Department of Animal Sciens
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01618526     History of Changes
Other Study ID Numbers: V02062012
Study First Received: May 30, 2012
Last Updated: August 5, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Dietary fibers
Butyrate
Short Chain Fatty Acids
Colon
Metabolic Syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014