Long-term Effects of Arabinoxylans on Intestinal Barrier Function

NCT01877044 | Completed DMC

• 1 other identifier: 123050
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Keywords

Prebiotics; Intestinal permeability; Gut barrier function; Immunity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

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

  Baseline and after 6 weeks of administration

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

  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.

  Baseline, after 3 and after 6 weeks of administration

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

  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.

  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)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

NAXUS 7.5 grams

EXPERIMENTAL

Arabinoxylan

Dietary Supplement: NAXUS

NAXUS 15.0 grams

EXPERIMENTAL

Arabinoxylan

Dietary Supplement: NAXUS

Interventions

NAXUS DIETARY_SUPPLEMENT

NAXUS 15.0 grams; NAXUS 7.5 grams

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 28214040 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• A.A.M. Masclee, Professor

  Department of Internal Medicine, Division of Gastroenterology-Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 13, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

NL (1)