niet specifiek voor aandoeningen, maar als voedingssupplement healthy
Conditions
Interventions
Dietary fiber is generally better tolerated with food. The recommendations for 
subjects in this study are to consume the study product twice daily during 
regular meals (e.g. in soup, sprinkled over mashed potatoes or salads) and/or 
dissolved in beverages (e.g. in water, juice or tea). If necessary, one serving 
of dietary fiber powder can be divided between a meal and a drink, which then 
are consumed at the same time.
The study product is taken according to protocol for 4 weeks (day 8-day 35). 
The amount of study product to be taken corresponds to 3 grams of dietary fiber 
per eating moment.
Sponsors
Nutricia Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 45 and <= 70 years 2. Body Mass Index (BMI) >= 18.5 and <= 29.9 kg/m2 3. Written informed consent 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 before screening.
Exclusion criteria
Exclusion criteria: 1. Presence or prior history of chronic gastrointestinal diseases (e.g., gastric ulcers, ulcerative colitis, Crohn*s disease) or history of abdominal surgery involving resection of bowel (small or large intestine). 2. Presence of any other medical conditions where gastrointestinal function is commonly/ likely affected, such as: a. auto-immune diseases (e.g., type I diabetes mellitus, multiple sclerosis, systemic lupus erythematosus). b. eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge-eating disorder). c. any bowel/gastrointestinal dysfunction as sequelae of stroke. 3. Any chronic diseases (including but not limited to hypertension, dyslipidaemia, type 2 diabetes mellitus, thyroid disorders) which are uncontrolled with the use of medication/therapy. 4. Severe acute liver disease or chronic liver disease. 5. Severe or chronic renal disease or requirement for haemodialysis. 6. Colonoscopy, irrigoscopy or other bowel cleansing, or other surgical procedures related to the GI track (e.g. colon polypectomy, appendectomy) or requiring the use of systemic antibiotics within 1 month before screening or planned during the participation in the study. 7. Use of enemas, laxatives, antacids, proton pump inhibitors, prokinetics drugs (e.g. metoclopramide, medications that affect motility), digestive enzymes, narcotic/morphine analgesics within 1 week before the screening or intended use during the participation in the study. 8. Following a vegetarian or vegan diet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter is a change from baseline (measured on Day 7) in the reported severity of GI symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) for diarrhoea dimension at week 4 post-baseline (i.e. measured on Day 35) [score]. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are changes in: - weekly changes from baseline (i.e. measured on Day 7) in the reported severity of GI symptoms assessed by the GSRS for diarrhoea dimension at week 1, week 2, and week 3 post-baseline (i.e. measured on Day 14, Day 21, and Day 28) [score]. - weekly changes from baseline (i.e. measured on Day 7) 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 post-baseline (i.e. measured on Day 14, Day 21, Day 28, and Day 35) [score]. - number of (S)AE's and side-effects. | — |
Countries
Netherlands
Outcome results
None listed