Skip to content

The impact of a dried vegetable on bowel function and gut microbiota in subjects with bowel function issues

The impact of a dried vegetable on bowel function and gut microbiota in subjects with bowel function issues - Impact of a dried vegetable on bowel function and gut microbiota

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53536
Enrollment
160
Registered
2022-05-16
Start date
2022-08-22
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

niet medische problemen met darmfunctie (stoelgang) bowel function issues defecation problems difficulty to have bowel movements

Interventions

A vegetable product consisting of dried chicory root cubes containing 85% dietary fibre is added to the daily diet. The intervention product is consumed twice daily for four weeks with a maximum dos

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 20 - 80 years old • Unsatisfied with bowel habits (self-reported), rated on a visual analogue scale (VAS, 0-10) as

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

MeasureTime frame
To compare four-week differences in bowel function assessed by stool frequency, stool consistency, ease of defecation, feeling of incomplete bowel emptying and bowel habit satisfaction between subjects with bowel function issues consuming either 15 g/day dried chicory root particles or placebo (rice puff crisp particles).

Secondary

MeasureTime frame
To compare four-week differences in bowel function assessed by stool frequency, stool consistency, ease of defecation, feeling of incomplete bowel emptying and bowel habit satisfaction and gut microbiota and its activity, quality of life, constipation symptom assessment between subjects with bowel function issues consuming three different dosages dried chicory root particles or placebo (rice puff particles). Furthermore, to compare four-week evolution of bowel function, gut microbiota and its activity over time in subjects with bowel function issues consuming dried chicory root particles or placebo.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)