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

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ClinicalTrials.gov Identifier: NCT01618526
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Western Style Diet Dietary Supplement: Healthy Carbohydrate Diet Not Applicable

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  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
Study Start Date : April 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Starch
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Feces-short chain fatty acids [ Time Frame: Baseline and 4 weeks ]
    Concentration of short chain fatty acids


Secondary Outcome Measures :
  1. A change in gut microbiome evaluated by 16 S-RNA analysis [ Time Frame: Baseline and 4 weeks ]
  2. Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis. [ Time Frame: Baseline and 4 weeks ]
  3. Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17). [ Time Frame: Baseline and 4 weeks ]
  4. 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 ]
  5. Activation of T-cells in mucosa described by reduced expression of CD25 and CD69. [ Time Frame: Baseline and 4 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618526


Locations
Denmark
Aarhus University
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Knud Erik Bach Knudsen, Professor Aarhus University, Department of Animal Sciens

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01618526     History of Changes
Other Study ID Numbers: V02062012
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: August 2013

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

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