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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Western Style Diet
Healthy Carbohydrate Diet
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metabolic Syndrome focused on measuring Dietary fibers, Butyrate, Short Chain Fatty Acids, Colon, Metabolic Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Healthy Carbohydrate Diet

Western Style Diet

Arm Description

4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch

4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans.

Outcomes

Primary Outcome Measures

Feces-short chain fatty acids
Concentration of short chain fatty acids

Secondary Outcome Measures

A change in gut microbiome evaluated by 16 S-RNA analysis
Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis.
Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17).
Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-β).
Activation of T-cells in mucosa described by reduced expression of CD25 and CD69.

Full Information

First Posted
May 30, 2012
Last Updated
May 28, 2015
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01618526
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: a western style diet, WSD, with a low fiber content and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Dietary fibers, Butyrate, Short Chain Fatty Acids, Colon, Metabolic Syndrome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Carbohydrate Diet
Arm Type
Active Comparator
Arm Description
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch
Arm Title
Western Style Diet
Arm Type
Placebo Comparator
Arm Description
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans.
Intervention Type
Dietary Supplement
Intervention Name(s)
Western Style Diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Healthy Carbohydrate Diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Feces-short chain fatty acids
Description
Concentration of short chain fatty acids
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
A change in gut microbiome evaluated by 16 S-RNA analysis
Time Frame
Baseline and 4 weeks
Title
Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis.
Time Frame
Baseline and 4 weeks
Title
Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17).
Time Frame
Baseline and 4 weeks
Title
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
Title
Activation of T-cells in mucosa described by reduced expression of CD25 and CD69.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knud Erik Bach Knudsen, Professor
Organizational Affiliation
Aarhus University, Department of Animal Sciens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27434092
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.
Results Reference
derived

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

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