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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Maltodextrin |
|
| NAXUS 7.5 grams | Experimental | Arabinoxylan |
|
| NAXUS 15.0 grams | Experimental | Arabinoxylan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAXUS | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A.A.M. Masclee, Professor | Department of Internal Medicine, Division of Gastroenterology-Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229 HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28214040 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Dietary Supplement |
|
| 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 |
| 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 |
| 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. | Baseline, after 3 and after 6 weeks of adminstration |
| 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) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |