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

October 26, 2009
October 26, 2009
March 2009
May 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
adverse events [ Time Frame: whole study period ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Juniors)
In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects: a Randomized, Placebo-controlled, Double-blind, Cross-over Study

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Gastrointestinal Health
  • Healthy Subjects
  • 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
  • Experimental: Wheat Bran Extract
    Intervention: Dietary Supplement: Wheat Bran Extract
  • Placebo Comparator: placebo
    Intervention: Dietary Supplement: placebo
François 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
October 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
8 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01001949
ML5282 junior
Yes
Kristin Verbeke, Ph.D., Katholieke Universiteit Leuven
Fugeia NV
Not Provided
Study Director: Willem Broekaert, Ph.D. Fugeia NV
Fugeia NV
October 2009

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