Impact of a Dried Vegetable on Bowel Function and Gut Microbiota

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Bowel Function Dissatisfaction

In brief

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.

Key facts

Study ID: NCT05473793
Run by: Wageningen University
People needed: 160
Starts: 2022-08-22
Expected to finish: 2025-06-01
Last updated by the study team: 2025-02-25

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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 \&amp; 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 is running

Wageningen University & Research, Division of Human Nutrition & Health — Wageningen, Gelderland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.