Long-term Effects of Arabinoxylans on Intestinal Barrier Function

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: NAXUS

Study type: Interventional

Funder types: Other

Identifiers

NCT01877044

123050

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Placebo

NAXUS 7.5 grams

Experimental group

Description:

Arabinoxylan

Treatment:

Dietary Supplement: NAXUS

NAXUS 15.0 grams

Experimental group

Description:

Arabinoxylan

Treatment:

Dietary Supplement: NAXUS