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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001949
• Other study ID #: ML5282 junior
• Status: Completed
• Phase: N/A
• First received: October 26, 2009
• Last updated: October 26, 2009
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Fugeia NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastrointestinal Health
• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
Belgium	Department of Gastrointestinal Research, Laboratory Digestion and Absorption	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Fugeia NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bifidobacteria content in feces		day 19 or 20 of each intervention period	No
Primary	butyric acid content in feces		day 19 or 20 of each intervention period	No
Primary	stool frequency		third week of each intervention period	No
Secondary	adverse events		whole study period	Yes