Status:
COMPLETED
Fiber Tolerance Study
Lead Sponsor:
Nutricia Research
Collaborating Sponsors:
NCRU (Nutrition Clinical Research Unit)
Conditions:
Gastrointestinal Tolerance of Dietary Fiber
Eligibility:
All Genders
45-69 years
Phase:
EARLY_PHASE1
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 ne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06115057
Start Date
October 4 2023
End Date
December 22 2023
Last Update
February 6 2024
Active Locations (1)
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1
Nutrition Clinical Research Unit
Utrecht, Netherlands, 3584CT