Clinical trial NCT01877044: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Prebiotics
Intestinal permeability
Gut barrier function
Immunity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: Baseline and after 6 weeks of administration
Secondary outcomes:
measure: To assess the change from baseline intestinal barrier function at 6 weeks, by assessing the tight junction structure and proteins in colonic biopsies.
timeFrame: Baseline and after 6 weeks of administration
measure: To assess the change from baseline local and systemic immune system performance at 6 weeks.
timeFrame: Baseline and after 6 weeks administration
measure: To assess the change from baseline prebiotic properties at 3 and 6 weeks, by collecting faecal samples, intestinal contents and mucosal contents.
timeFrame: Baseline, after 3 and after 6 weeks of administration
measure: To assess the change from baseline glucose and lipid metabolism at 3 and 6 weeks
timeFrame: Baseline, after 3 and after 6 weeks of adminstration
measure: To assess the effect of different doses of NAXUS administration on tolerance and digestive (dys)comfort.
timeFrame: 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)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Department of Internal Medicine, Division of Gastroenterology-Hepatology
name: A.A.M. Masclee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.