Fiber Tolerance Study

Study Overview
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Brief Summary
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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.

Official Title
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The Investigation of Gastrointestinal Tolerance of a Novel Fibre Blend Among ≥45-<70-year-old Men and Women

Conditions
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Gastrointestinal Tolerance of Dietary Fiber

Intervention / Treatment
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* Dietary Supplement: Fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 45 and ≤ 70 years Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2 Signed consent form Willingness and ability to comply with the protocol Good general health Defecation frequency: between three bowel movements per week and three bowel movements per day within a month for screening. 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: autoimmune diseases (e.g. diabetes mellitus type I, multiple sclerosis, systemic lupus erythematosus). eating disorders (e.g. anorexia nervosa, bulimia nervosa, binge eating disorder). intestinal/gastrointestinal disorder due to a stroke. 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: open-label, single-arm, single-site
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Fiber | Dietary Supplement: Fiber<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fiber Tolerance Gastro-intestinal Safety