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

This study has been completed.

Sponsor:

Information provided by:

Fugeia NV

ClinicalTrials.gov Identifier:

NCT01001949

First received: October 26, 2009

Last updated: NA

Last verified: October 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 26, 2009

Last Updated Date

October 26, 2009

Start Date ^ICMJE

March 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bifidobacteria content in feces [ Time Frame: day 19 or 20 of each intervention period ] [ Designated as safety issue: No ]
butyric acid content in feces [ Time Frame: day 19 or 20 of each intervention period ] [ Designated as safety issue: No ]
stool frequency [ Time Frame: third week of each intervention period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

adverse events [ Time Frame: whole study period ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Gastrointestinal Health
Healthy Subjects

Intervention ^ICMJE

Dietary Supplement: Wheat Bran Extract
soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner
Dietary Supplement: placebo
soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner

Study Arm (s)

Experimental: Wheat Bran Extract
Intervention: Dietary Supplement: Wheat Bran Extract
Placebo Comparator: placebo
Intervention: Dietary Supplement: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 12 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01001949

Other Study ID Numbers ^ICMJE

ML5282 junior

Has Data Monitoring Committee

Yes

Responsible Party

Kristin Verbeke, Ph.D., Katholieke Universiteit Leuven

Study Sponsor ^ICMJE

Fugeia NV

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Willem Broekaert, Ph.D.

Fugeia NV

Information Provided By

Fugeia NV

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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