Dried chicory root particles: The intervention product consists of chicory root that have been sliced and dried and are provided in the form of particles (\~3mm).
Placebo: The control arm receives a placebo consisting of rice puff particles.
Study summary
A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and a period of four intervention-weeks that assesses the intake of different dosages of a complex fiber product on bowel function via microbiota changes in subjects that are unsatisfied with their current bowel function.
Eligibility
Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 20 - 80 years old
* Unsatisfied with bowel functions (self-reported), rated on a visual analogue scale (VAS, 0-10) as less than 6
* Four or less bowel movements per week (low stool frequency) and/or
* Hard, lumpy or solid stools (Bristol stool form 1-4) during 90% of bowel movements (hard to solid consistency)
* Able to read and understand Dutch or English
Exclusion Criteria:
* Having a history of medical or surgical events that may significantly affect the study outcome: e.g., IBS or IBD patients and subjects with medically diagnosed constipation (i.e., constipation related to anatomic, medication-related, or readily identifiable physiological causes.)
* Less than one bowel movement per week during the screening
* Medical drug use:
* Antibiotic use within 3 months of the study screenings day
* Chronic use of antacids and PPI's
* Use of laxatives during the screening
* Chronic use of blood glucose lowering medication
* Consumption of supplements containing fibres (other than laxatives), pro-/ post-/ synbiotics 1 month before the screening
* Not willing to provide faecal samples
* Unable to comply with proper study procedures
* For women of childbearing age: current or planned pregnancy, lactation
* Known allergic reactions to plants from the Asteraceae (Compositae) family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory etc.)
* Reported unexplained weight loss or weight gain of greater than 5 kg in the month prior to pre-study screening
* Reported slimming or medically prescribed diet
* Reported macrobiotic lifestyle
* Personnel the Division of Human Nutrition \& Health or the Laboratory of Microbiology
* Current participation in other medical scientific research
* Not having a general practitioner
* Not willing to be informed about accidental discoveries in relation to the subjects health
Primary outcome measure(s)
Bowel function (differences highest dose vs placebo) - bowel function satisfaction — Change after the intervention of 4 weeks Bowel function satisfaction is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (differences highest dose vs placebo) - ease of defecation — Change after the intervention of 4 weeks Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (differences highest dose vs placebo) - feeling of incomplete bowel emptying — Change after the intervention of 4 weeks Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (differences highest dose vs placebo) - stool consistency — Change after the intervention of 4 weeks Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea).
Bowel function (differences highest dose vs placebo) - stool frequency — Change after the intervention of 4 weeks Stool frequency is measured by counting number of bowel movements per week.
Trial sites (1)
Facility
City
Region
Status
Wageningen University & Research, Division of Human Nutrition & Health
Wageningen
Gelderland
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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