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Long-term Effects of Arabinoxylans on Intestinal Barrier Function

Primary Purpose

Obesity, Overweight

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

NAXUS

Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring Prebiotics, Intestinal permeability, Gut barrier function, Immunity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

NAXUS 7.5 grams

NAXUS 15.0 grams

Arm Description

Maltodextrin

Arabinoxylan

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To assess the change from baseline intestinal barrier function at 6 weeks, by assessing the tight junction structure and proteins in colonic biopsies.

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.

To assess the change from baseline local and systemic immune system performance at 6 weeks.

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.

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

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.

Via questionnaires stool frequency, stool consistency and gastrointestinal symptoms will be measured.

Full Information

NCT ID

NCT01877044

First Posted

June 5, 2013

Last Updated

July 6, 2015

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01877044

Brief Title

Long-term Effects of Arabinoxylans on Intestinal Barrier Function

Official Title

The Effects of Long-term Arabinoxylan Administration on Intestinal Barrier Function and Innate Immunity

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

Keywords

Prebiotics, Intestinal permeability, Gut barrier function, Immunity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Maltodextrin

Arm Title

NAXUS 7.5 grams

Arm Type

Experimental

Arm Description

Arabinoxylan

Arm Title

NAXUS 15.0 grams

Arm Type

Experimental

Arm Description

Arabinoxylan

Intervention Type

Dietary Supplement

Intervention Name(s)

NAXUS

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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.

Time Frame

Baseline and after 6 weeks of administration

Secondary Outcome Measure Information:

Title

To assess the change from baseline intestinal barrier function at 6 weeks, by assessing the tight junction structure and proteins in colonic biopsies.

Description

Time Frame

Baseline and after 6 weeks of administration

Title

To assess the change from baseline local and systemic immune system performance at 6 weeks.

Description

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.

Time Frame

Baseline and after 6 weeks administration

Title

To assess the change from baseline prebiotic properties at 3 and 6 weeks, by collecting faecal samples, intestinal contents and mucosal contents.

Description

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.

Time Frame

Baseline, after 3 and after 6 weeks of administration

Title

To assess the change from baseline glucose and lipid metabolism at 3 and 6 weeks

Description

Time Frame

Baseline, after 3 and after 6 weeks of adminstration

Title

To assess the effect of different doses of NAXUS administration on tolerance and digestive (dys)comfort.

Description

Via questionnaires stool frequency, stool consistency and gastrointestinal symptoms will be measured.

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

A.A.M. Masclee, Professor

Organizational Affiliation

Department of Internal Medicine, Division of Gastroenterology-Hepatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University Medical Center

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6229 HX

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

28214040

Citation

Salden BN, Troost FJ, Wilms E, Truchado P, Vilchez-Vargas R, Pieper DH, Jauregui R, Marzorati M, van de Wiele T, Possemiers S, Masclee AA. Reinforcement of intestinal epithelial barrier by arabinoxylans in overweight and obese subjects: A randomized controlled trial: Arabinoxylans in gut barrier. Clin Nutr. 2018 Apr;37(2):471-480. doi: 10.1016/j.clnu.2017.01.024. Epub 2017 Feb 3.

Results Reference

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Long-term Effects of Arabinoxylans on Intestinal Barrier Function

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