The investigational study product used in this clinical trial is a soft drink containing an arabinoxylan-oligosaccharides (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 two WBE doses on various parameters of gastrointestinal health. Additionally, safety was analyzed using treatment emergent Adverse Events (AEs) and clinical blood parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
66
soft drink comprising high WBE dose 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 after dinner
Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Leuven, Belgium
Bifidobacteria content in feces
Time frame: day 19 or 20 of each intervention
butyric acid content in feces
Time frame: day 19 or 20 of each intervention
p-cresol content in urine
Time frame: day 19-21 of each intervention
stool frequency
Time frame: third week of each intervention
adverse events
Time frame: whole study
clinical blood parameters
Time frame: day 21 of each intervention
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