NCT01001949

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Fugeia NV · Industry
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

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).

Conditions

• Gastrointestinal Health
• Healthy Subjects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-05-01
• Completion: 2009-10-01
• First posted: 2009-10-27
• Last updated: 2009-10-27

Locations

1 site across 1 country: Belgium