In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Juniors)

In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects: a Randomized, Placebo-controlled, Double-blind, Cross-over Study

The investigational product used in this study is a soft drink containing an arabinoxylan-oligosaccharide (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE).

The objective of this study is to analyze the effect of the intake of WBE on various parameters of gastrointestinal health in children (8-12 yrs). Additionally, safety was analyzed using treatment emergent Adverse Events (AEs).

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Gastrointestinal Health
• Intervention / Treatment: Dietary supplement: Wheat Bran Extract; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Department of Gastrointestinal Research, Laboratory Digestion and Absorption

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• regular eating habits
• consent to take in the study product according to the study protocol
• consent of parents for follow-up of the protocol
• subject is willing to maintain his/her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)

Exclusion Criteria:

• low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial
• recent use of antibiotics
• abdominal surgery in the past
• use of medication or dietary supplements known to influence gastrointestinal tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti-diarrhea medication and/or probiotic medication
• serious illness within 3 months of start of clinical trial
• chronic gastrointestinal conditions such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance
• complete anesthetics within 3 month of the start of the clinical trial
• allergy for wheat products
• celiac disease
• Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Dietary supplement: placebo; soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner
Experimental: Wheat Bran Extract	Dietary supplement: Wheat Bran Extract; soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bifidobacteria content in feces	day 19 or 20 of each intervention period
butyric acid content in feces	day 19 or 20 of each intervention period
stool frequency	third week of each intervention period

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse events	whole study period

Collaborators and Investigators

• Sponsor: Fugeia NV
• Investigators: Study Director: Willem Broekaert, Ph.D., Fugeia NV

Publications and helpful links

General Publications

• Francois IE, Lescroart O, Veraverbeke WS, Marzorati M, Possemiers S, Hamer H, Windey K, Welling GW, Delcour JA, Courtin CM, Verbeke K, Broekaert WF. Effects of wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal parameters in healthy preadolescent children. J Pediatr Gastroenterol Nutr. 2014 May;58(5):647-53. doi: 10.1097/MPG.0000000000000285.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): October 27, 2009
• Last Update Submitted That Met QC Criteria: October 26, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: ML5282 junior