Clinical trial NCT06115057: Fiber Tolerance Study
Official title: The Investigation of Gastrointestinal Tolerance of a Novel Fibre Blend Among ≥45-<70-year-old Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gastrointestinal Tolerance of Dietary Fiber
Keywords: Fiber Tolerance Gastro-intestinal Safety
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
Collaborators: name: NCRU (Nutrition Clinical Research Unit)
First posted: 2023-11-02
Enrollment: 43
Sex: ALL
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, single-arm, single-site
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: GSRS change
timeFrame: 4 weeks
Secondary outcomes:
measure: GSRS change
timeFrame: week 1, week 2, week 3,
measure: GSRS change
timeFrame: week 1, week 2, week 3, week 4
Other outcomes:
measure: GSRS
timeFrame: week 1, week 2, week 3, week 4
measure: BSFC
timeFrame: week 1, week 4
measure: Defecation frequency
timeFrame: week 1, week 2, week 3, week 4
measure: DQLQ
timeFrame: 4 weeks
measure: Stool
timeFrame: week 2, week 3, week 4
Locations:
city: Utrecht
country: Netherlands
facility: Nutrition Clinical Research Unit
Study officials:
References: