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Completed

NCT Number: NCT01618526

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Western Style Diet

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. Feces-short chain fatty acids

    Time frame: Baseline and 4 weeks

    Concentration of short chain fatty acids

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Jun 13, 2012
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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