Impact of a Dried Vegetable on Bowel Function and Gut Microbiota
The Impact of a Dried Vegetable on Bowel Function and Gut Microbiota in Subjects With Bowel Function Issues
Wageningen University
160 participants
Aug 22, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- - 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 Criteria19
- 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
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Interventions
The intervention product consists of chicory root that have been sliced and dried and are provided in the form of particles (\~3mm).
The control arm receives a placebo consisting of rice puff particles.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05473793