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Clinical Trials in the Netherlands / NCT05473793
Recruiting Not applicable

Impact of a Dried Vegetable on Bowel Function and Gut Microbiota

NCT05473793 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2022-08-22
Last updated
2025-02-25

Condition(s) studied

Bowel Function Dissatisfaction

Investigational drug(s) / intervention(s)

Dried chicory root particlesPlacebo

Dried chicory root particles: The intervention product consists of chicory root that have been sliced and dried and are provided in the form of particles (\~3mm).

Placebo: The control arm receives a placebo consisting of rice puff particles.

Study 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

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Wageningen University & Research, Division of Human Nutrition & Health Wageningen Gelderland Recruiting

More Wageningen University trials in the Netherlands

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05473793 on ClinicalTrials.gov ↗ ← All trials in the Netherlands