Long-term Effects of Arabinoxylans on Intestinal Barrier Function

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877044
• Other study ID #: 123050
• Status: Completed
• Phase: N/A
• First received: June 5, 2013
• Last updated: July 6, 2015
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• NAXUS

• Placebo

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline and after 6 weeks of administration	No
Secondary	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.	Baseline and after 6 weeks administration	No
Secondary	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.	Baseline, after 3 and after 6 weeks of administration	No
Secondary	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 ß-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations.	Baseline, after 3 and after 6 weeks of adminstration	No
Secondary	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.	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)	Yes