Effects of a dried vegetable on bowel function and gut health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.