The impact of a dried vegetable on bowel function and gut microbiota in subjects with bowel function issues
- Conditions
- niet medische problemen met darmfunctie (stoelgang)bowel function issuesdefecation problemsdifficulty to have bowel movements
- Registration Number
- NL-OMON53536
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
• 20 - 80 years old
• Unsatisfied with bowel habits (self-reported), rated on a visual analogue
scale (VAS, 0-10) as <6 AND
• Four or less bowel movements per week AND/OR
• Hard, lumpy or solid stools (Bristol stool form 1-4) during at least 90% of
the bowel movements
• Able to speak and understand Dutch or English
• Having a history of medical or surgical events that may significantly affect
the study outcome: 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 period.
• Medical drug use:
o Antibiotic use within 3 months of the screening
o Chronic use of antacids and PPI*s
o Use of laxatives 1 month during the screening
o Chronic use of blood glucose lowering medication
• Consumption of supplements containing fibres (other than laxatives), pro-/
post-/ synbiotics 1 month before the screening
• Unable to comply with proper study procedures
• Not willing to provide faecal samples
• 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 > 5 kg in the month prior
to screening
• Reported slimming or medically prescribed diet or macrobiotic life-style
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare four-week differences in bowel function assessed by stool frequency,<br /><br>stool consistency, ease of defecation, feeling of incomplete bowel emptying and<br /><br>bowel habit satisfaction between subjects with bowel function issues consuming<br /><br>either 15 g/day dried chicory root particles or placebo (rice puff crisp<br /><br>particles). </p><br>
- Secondary Outcome Measures
Name Time Method <p>To compare four-week differences in bowel function assessed by stool frequency,<br /><br>stool consistency, ease of defecation, feeling of incomplete bowel emptying and<br /><br>bowel habit satisfaction and gut microbiota and its activity, quality of life,<br /><br>constipation symptom assessment between subjects with bowel function issues<br /><br>consuming three different dosages dried chicory root particles or placebo (rice<br /><br>puff particles). Furthermore, to compare four-week evolution of bowel function,<br /><br>gut microbiota and its activity over time in subjects with bowel function<br /><br>issues consuming dried chicory root particles or placebo.</p><br>