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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-10-31

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).

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Detailed Description

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Conditions

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Gastrointestinal Health Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Wheat Bran Extract

Group Type EXPERIMENTAL

Wheat Bran Extract

Intervention Type DIETARY_SUPPLEMENT

soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner

Interventions

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Wheat Bran Extract

soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner

Intervention Type DIETARY_SUPPLEMENT

placebo

soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes