Impact of a Dried Vegetable on Bowel Function and Gut Microbiota
ConditionBowel Function Dissatisfaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorWageningen University
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Antibiotic use within 3 months of the study screenings day
Chronic use of antacids and PPI's
Trial design
Treatments tested in this trial
- Dried chicory root particles
- Placebo
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
Wageningen University
Lead sponsor
WholeFiber BV
Collaborator
Wageningen University and Research, Laboratory of Microbiology
Collaborator
Wageningen University and Research, Division of Human Nutrition & Health
Collaborator
Wageningen University and Research
Collaborator
Source ClinicalTrials.gov