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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wheat Bran Extract | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat Bran Extract | Dietary Supplement | soft drink comprising WBE 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 period | |
| butyric acid content in feces | day 19 or 20 of each intervention period | |
| stool frequency | third week of each intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | whole study period |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24368315 | Derived | Francois IE, Lescroart O, Veraverbeke WS, Marzorati M, Possemiers S, Hamer H, Windey K, Welling GW, Delcour JA, Courtin CM, Verbeke K, Broekaert WF. Effects of wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal parameters in healthy preadolescent children. J Pediatr Gastroenterol Nutr. 2014 May;58(5):647-53. doi: 10.1097/MPG.0000000000000285. |
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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 dinner |
|
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |