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

Sponsor

Fugeia NV (Industry)

Overall Status

Completed

CT.gov ID

NCT01001949

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Health Healthy Subjects	Dietary Supplement: Wheat Bran Extract Dietary Supplement: placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: placebo	Dietary Supplement: placebo soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner

Arm

Intervention/Treatment

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

Placebo Comparator: placebo

Dietary Supplement: placebo

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

Outcome Measures

Primary Outcome Measures

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

adverse events [whole study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastrointestinal Research, Laboratory Digestion and Absorption	Leuven		Belgium	3000

Sponsors and Collaborators

Fugeia NV

Investigators

Study Director: Willem Broekaert, Ph.D., Fugeia NV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01001949

Other Study ID Numbers:

ML5282 junior

First Posted:

Oct 27, 2009

Last Update Posted:

Oct 27, 2009

Last Verified:

Oct 1, 2009

Study Results

No Results Posted as of Oct 27, 2009