Nutrition Clinical Research Unit
Utrecht, 3584CT, Netherlands
NCT Number: NCT06115057
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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Notify Me45 year–69 year
All sexes
Interventional
Early Phase 1
Utrecht, 3584CT, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 4 weeks
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.
Time frame: week 1, week 2, week 3,
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.
Time frame: week 1, week 2, week 3, week 4
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.
Time frame: week 1, week 2, week 3, week 4
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].
Time frame: week 1, 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.
Time frame: week 1, week 2, week 3, week 4
Weekly average frequency of defecation, derived from the number of faecal form types assessed by the Bristol Stool Form Chart.
Time frame: 4 weeks
Digestion-associated Quality of life assessed by the Digestion-associated Quality of Life Questionnaire (DQLQ) at baseline and at week 4 post-baseline.
Time frame: week 2, week 3, week 4
Microbiota and other outcome parameters assessed using collected faecal samples in the baseline week and every 7 days over 4 weeks post-baseline:
Nutricia Research
Industry
The Investigation of Gastrointestinal Tolerance of a Novel Fibre Blend Among ≥45-<70-year-old Men and Women
Acronym: Gitomix
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.