Fiber Tolerance Study

Early Phase 1

Completed

• Conditions: Gastrointestinal Tolerance of Dietary Fiber
• Interventions: Dietary Supplement: Fiber

• Registration Number: NCT06115057
• Lead Sponsor: Nutricia Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-18
• Study Start: 2023-10-04
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-02
• Primary Completion: 2023-12-22
• Study Completion: 2023-12-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. Age ≥ 45 and ≤ 70 years
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
3. Signed consent form
4. Willingness and ability to comply with the protocol
5. Good general health
6. Defecation frequency: between three bowel movements per week and three bowel movements per day within a month for screening.

Exclusion Criteria

1. 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).

2. Presence of other medical conditions where gastrointestinal function often/probably is affected, such as:

   1. autoimmune diseases (e.g. diabetes mellitus type I, multiple sclerosis, systemic lupus erythematosus).
   2. eating disorders (e.g. anorexia nervosa, bulimia nervosa, binge eating disorder).
   3. intestinal/gastrointestinal disorder due to a stroke.

3. 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.

4. Severe acute liver disease or chronic liver disease.

5. Severe or chronic kidney disease or need for hemodialysis.

6. 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.

7. 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.

8. Following a vegetarian or vegan diet.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Fiber	Fiber

Primary Outcome Measures

Name	Time	Method
GSRS change	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.

Secondary Outcome Measures

Name	Time	Method
GSRS change	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.

Trial Locations

Locations (1)

Nutrition Clinical Research Unit; 🇳🇱 Utrecht, Netherlands