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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wheat Bran Extract (high dose) | Experimental |
| |
| Wheat Bran Extract (low dose) | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wheat bran extract | Dietary Supplement | soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bifidobacteria content in feces | day 19 or 20 of each intervention | |
| butyric acid content in feces | day 19 or 20 of each intervention | |
| p-cresol content in urine | day 19-21 of each intervention | |
| stool frequency | third week of each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | whole study | |
| clinical blood parameters | day 21 of each intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Willem Broekaert, Ph.D. | Fugeia NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal Research, Laboratory Digestion and Absorption | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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|
| placebo | Dietary Supplement | soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and after dinner |
|
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |