NCT01001949

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

October 26, 2009

Last Update Submit

October 26, 2009

Conditions

Gastrointestinal HealthHealthy Subjects

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • adverse events

    whole study period

Study Arms (2)

Wheat Bran Extract

EXPERIMENTAL
Dietary Supplement: Wheat Bran Extract

placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

Wheat Bran ExtractDIETARY_SUPPLEMENT

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

Wheat Bran Extract
placeboDIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Research, Laboratory Digestion and Absorption

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Francois IE, Lescroart O, Veraverbeke WS, Marzorati M, Possemiers S, Hamer H, Windey K, Welling GW, Delcour JA, Courtin CM, Verbeke K, Broekaert WF. Effects of wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal parameters in healthy preadolescent children. J Pediatr Gastroenterol Nutr. 2014 May;58(5):647-53. doi: 10.1097/MPG.0000000000000285.

    PMID: 24368315DERIVED

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Willem Broekaert, Ph.D.

    Fugeia NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

October 1, 2009

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

BE(1)