Effects of a dried vegetable on bowel function and gut health
The Impact of a Dried Vegetable on Bowel Function and Gut Microbiota in Subjects With Bowel Function Issues
NA · Wageningen University · NCT05473793
This study is testing whether a high-fiber dried vegetable can improve bowel habits and gut health for people who are unhappy with their digestion.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Wageningen University (other) |
| Locations | 1 site (Wageningen, Gelderland) |
| Trial ID | NCT05473793 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of a dried vegetable product high in dietary fiber on bowel function and gut microbiota in individuals dissatisfied with their bowel habits. Participants will be randomly assigned to receive either the vegetable product or a placebo over a four-week period. The study aims to measure changes in stool frequency, consistency, ease of defecation, and overall satisfaction with bowel function. Additionally, the trial will explore whether these effects vary with different dosages of the fiber product and how they relate to changes in gut microbiota.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 20 to 80 who report dissatisfaction with their bowel function and experience low stool frequency or hard stool consistency.
Not a fit: Patients with diagnosed bowel disorders such as IBS or IBD, or those with severe constipation, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve bowel function and quality of life for individuals experiencing bowel dissatisfaction.
How similar studies have performed: While the specific use of dried chicory root is novel, previous studies have shown that increased fiber intake can positively affect bowel function and gut health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wageningen, Gelderland
- Wageningen University & Research, Division of Human Nutrition & Health — Wageningen, Gelderland, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Edith JM Feskens, Prof. dr
- Email: edith.feskens@wur.nl
- Phone: +31317482567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bowel Function Dissatisfaction, bowel function issues, constipation, gut microbiota, fiber intake, vegetable, intrinsic fiber