Long-term Effects of Arabinoxylans on Intestinal Barrier Function

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: NAXUS

• Registration Number: NCT01877044
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The higher prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic inflammatory condition through 1) production of pro-inflammatory cytokines by adipose tissue and 2) alterations in intestinal microbiota composition and associated increase in intestinal permeability. Healthcare costs related to these diseases are rising; prevention or delay of onset of disorders associated with overweight is needed. Administration of wheat arabinoxylans (NAXUS), a non-digestible carbohydrate, may change the intestinal microbiota composition and have beneficial effects on gut epithelial barrier, especially on permeability and innate immune function.

Objective: To assess the effects of NAXUS on intestinal barrier function, immune system performance and metabolic control. Prebiotic properties of NAXUS will be studied. Tolerance of the product in different doses will also be investigated.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-13
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-06
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Overweight men/women (BMI 28-35 kg/m2)
• Besides overweight, healthy human beings
• Fasting glucose <7.0 mmol/L
• Normal HbA1c (4.4 to 6.2%)
• Consistently stable body weight for at least 6 months (± 2 kg)

Exclusion Criteria

• Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
• Gastroenterological diseases or abdominal surgery;
• Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
• Abuse of products; alcohol (>20 alcoholic consumptions per week) and drugs
• Smoking
• Plans to lose weight or following a hypocaloric diet;
• Use of any medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing;
• Regular use of laxation products;
• Use of antibiotics in the 90 days prior to the start of study.
• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
• Known pregnancy, lactation (checked by a pregnancy test before start of study)
• Blood donation within 3 months before study period
• Prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. A list with forbidden products will be provided (E4 PreProbiotics).
• Self-admitted HIV-positive state
• History of any side effects towards intake of pro- or prebiotic supplements of any kind

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Maltodextrin
NAXUS 7.5 grams	NAXUS	Arabinoxylan
NAXUS 15.0 grams	NAXUS	Arabinoxylan

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to assess the change from baseline intestinal barrier function at 6 weeks, by performing a gut sugar permeability test.	Baseline and after 6 weeks of administration

Secondary Outcome Measures

Name	Time	Method
To assess the change from baseline local and systemic immune system performance at 6 weeks.	Baseline and after 6 weeks administration	Secondary outcome will be measured by the expression of immune parameters in colonic biopsies, by multiplex cytokine analysis in blood and Peripheral Blood Mononuclear Cell stimulation assays.
To assess the change from baseline prebiotic properties at 3 and 6 weeks, by collecting faecal samples, intestinal contents and mucosal contents.	Baseline, after 3 and after 6 weeks of administration	The microbial community composition, Short-chain Fatty Acid profiles in intestinal content and faeces and proteolytic activity markers in intestinal content and faeces will be determined.
To assess the change from baseline glucose and lipid metabolism at 3 and 6 weeks	Baseline, after 3 and after 6 weeks of adminstration	By determining glucose, insulin and triglyceride in blood samples. Cholesterol and free fatty acids will be measured as part of general blood profiling. Moreover effects on insulin sensitivity will be estimated by measuring HOMA-IR. Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations.
To assess the effect of different doses of NAXUS administration on tolerance and digestive (dys)comfort.	At baseline, after 1 wk of administration, after 2 wks of administration, after 3 wks of administration, after 4 wks of administration, after 5 wks of administration, after 6 wks of administration (in total 7 times)	Via questionnaires stool frequency, stool consistency and gastrointestinal symptoms will be measured.
To assess the change from baseline intestinal barrier function at 6 weeks, by assessing the tight junction structure and proteins in colonic biopsies.	Baseline and after 6 weeks of administration	Assessment will take place by immunofluorescent labelling and Polymerase Chain Reaction quantification of zonulin-1, claudin-3, occluding, myosin light chain kinase and phosphorylated myosin light chain.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands