NCT05473793 Impact of a Dried Vegetable on Bowel Function and Gut Microbiota
| NCT ID | NCT05473793 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wageningen University |
| Condition | Bowel Function Dissatisfaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-08-22 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-08-22 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05473793 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Bowel Function Dissatisfaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05473793 currently recruiting?
Yes, NCT05473793 is actively recruiting participants. Contact the research team at edith.feskens@wur.nl for enrollment information.
Where is the NCT05473793 trial being conducted?
This trial is being conducted at Wageningen, Netherlands.
Who is sponsoring the NCT05473793 clinical trial?
NCT05473793 is sponsored by Wageningen University. The trial plans to enroll 160 participants.