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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
29
soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner
soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner
Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Leuven, Belgium
Bifidobacteria content in feces
Time frame: day 19 or 20 of each intervention period
butyric acid content in feces
Time frame: day 19 or 20 of each intervention period
stool frequency
Time frame: third week of each intervention period
adverse events
Time frame: whole study period
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