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

Study Overview
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Brief Summary
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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).

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

Conditions
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Gastrointestinal Health, Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: Wheat Bran Extract
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wheat Bran Extract<br> | Dietary Supplement: Wheat Bran Extract<br>* soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner<br>|
| Placebo Comparator: placebo<br> | Dietary Supplement: placebo<br>* soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | whole study period |