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

Not Applicable

Completed

• Conditions: Gastrointestinal Health; Healthy Subjects
• Interventions: Dietary Supplement: Wheat Bran Extract; Dietary Supplement: placebo

• Registration Number: NCT01001949
• Lead Sponsor: Fugeia NV

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-05
• Status Verified: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Last Update Submitted: 2009-10-26
• Study First Posted: 2009-10-27
• Last Update Posted: 2009-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wheat Bran Extract	Wheat Bran Extract	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
adverse events	whole study period

Trial Locations

Locations (1)

Department of Gastrointestinal Research, Laboratory Digestion and Absorption; 🇧🇪 Leuven, Belgium