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

NCT01001949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2009-10-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fugeia NV

    lead INDUSTRY

Principal Investigators

  • Willem Broekaert, Ph.D. · Fugeia NV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-05-31
Completion
2009-10-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001949 on ClinicalTrials.gov