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| ID | Type | Description | Link |
|---|---|---|---|
| NL84292.056.23 | Other Identifier | CCMO, The Netherlands |
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| Name | Class |
|---|---|
| NCRU (Nutrition Clinical Research Unit) | UNKNOWN |
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Research shows that many people do not get enough dietary fiber through their normal diet. As a result, some nutrients are not properly absorbed into the bloodstream. The immune system however does need these nutrients. Dietary fibers are therefore important for health. Nutricia has developed a new blend of natural fibers that can help people get enough fiber.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Fiber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiber | Dietary Supplement | Subjects in this study are to consume the study product twice daily during regular meals. The fiber mix consists of different types of dietary fiber that are individually well tolerated for human consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| GSRS change | Change from baseline in the reported severity of GI symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) for diarrhea dimension at week 4 post-baseline. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| GSRS change | Weekly changes from baseline in the reported severity of GI symptoms assessed by the GSRS for diarrhea dimension at week 1, week 2, and week 3 post-baseline. | week 1, week 2, week 3, |
| GSRS change |
| Measure | Description | Time Frame |
|---|---|---|
| GSRS | The reported severity of GI symptoms assessed by the GSRS between week 1 v week 2, week 1 v week 3, week 1 v week 4, week 2 v week 3, week 2 v week 4, and week 3 v week 4 [score]. | week 1, week 2, week 3, week 4 |
| BSFC |
Inclusion Criteria:
Exclusion Criteria:
Presence or history of chronic gastrointestinal disorders (e.g. stomach ulcers, ulcerative colitis, Crohn's disease) or history of abdominal surgery with resection of the bowel (small or large intestine).
Presence of other medical conditions where gastrointestinal function often/probably is affected, such as:
Chronic diseases (including but not limited to hypertension, dyslipidaemia, type 2 diabetes mellitus, thyroid disorders) that cannot be controlled with the use of medication/therapy.
Severe acute liver disease or chronic liver disease.
Severe or chronic kidney disease or need for hemodialysis.
Colonoscopy, irrigoscopy or other bowel cleansing, or other surgical procedures related to the gastrointestinal tract (eg. colon polypectomy, appendectomy) or for which use of systemic antibiotics within 1 month before the screening is required or scheduled during participation in the study.
Use of enemas, laxatives, antacids, proton pump inhibitors, prokinetics (e.g. metoclopramide, drugs that affect motility), digestive enzymes, narcotic/morphine analgesics within 1 week prior to screening or intended use during participation in the study.
Following a vegetarian or vegan diet.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrition Clinical Research Unit | Utrecht | 3584CT | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42231910 | Derived | Dopheide L, Kozior M, Buco A, van Bergenhenegouwen J, Tims S, de Vogel-van den Bosch J, Roberts J, Jonkers D, Harvey L, van Helvoort A. A Diverse Fiber Mixture, Reflective of a Nutritionally Balanced Diet, Is Well Tolerated by Healthy Adults. Curr Dev Nutr. 2026 Apr 18;10(6):107695. doi: 10.1016/j.cdnut.2026.107695. eCollection 2026 Jun. |
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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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open-label, single-arm, single-site
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Weekly changes from baseline in the reported severity of GI symptoms assessed by the GSRS for abdominal pain, constipation, indigestion, and reflux dimensions at week 1, week 2, week 3, and week 4.
| week 1, week 2, week 3, week 4 |
Weekly average faecal form type assessed by the Bristol Stool Form Chart at each defecation in the baseline week, at week 1, and week 4 post-baseline.
| week 1, week 4 |
| Defecation frequency | Weekly average frequency of defecation, derived from the number of faecal form types assessed by the Bristol Stool Form Chart. | week 1, week 2, week 3, week 4 |
| DQLQ | Digestion-associated Quality of life assessed by the Digestion-associated Quality of Life Questionnaire (DQLQ) at baseline and at week 4 post-baseline. | 4 weeks |
| Stool | Microbiota and other outcome parameters assessed using collected faecal samples in the baseline week and every 7 days over 4 weeks post-baseline:
| week 2, week 3, week 4 |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |