The main objective of the study is to assess whether a dried multifibre vegetable improves bowel function assessed by stool frequency, consistency, defecation ease, feeling of incomplete bowel emptying and satisfaction. Secondary objectives are to…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
niet medische problemen met darmfunctie (stoelgang)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Bowel function issues can have a substantial effect on quality of life.
Additional fibre intake might modulate bowel function and gut microbiota,
thereby increasing stool frequency and consistency. This could improve
defecation ease, feeling of incomplete bowel emptying and bowel function
satisfaction. We hypothesize that a dried vegetable, that is naturally high in
fibre within plant cells could improve bowel function in subjects with bowel
function issues.
Study objective
The main objective of the study is to assess whether a dried multifibre
vegetable improves bowel function assessed by stool frequency, consistency,
defecation ease, feeling of incomplete bowel emptying and satisfaction.
Secondary objectives are to assess whether these effects are dose-dependent and
associated with the modulation of the gut microbiota and activity. Furthermore,
the adaption of bowel function and adaptation of the gut microbiota and
activity over time will be analysed.
Study design
A parallel, randomized, double-blind, placebo-controlled trial of four weeks
with one placebo control and three intervention arms that differ in
intervention product dose.
Intervention
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 dose of 15 g/day. The control
(placebo) consists of easily digestible rice puff pieces and is consumed in the
same manner as the intervention.
Study burden and risks
The intervention is therapeutic for three-quarters of the subjects and
non-therapeutic for the remaining quarter (placebo). Subjects will consume the
product split into two daily portions and monitor their bowel functions daily
by means of a short questionnaire while maintaining their habitual diet and
lifestyle. Subjects will collect a weekly faecal sample (5x), fill in twice two
retrospective questionnaires on quality of life and constipation symptom
assessment, fill in once a short questionnaire about their fiber intake and
twice a three-day food recall (begin and end of study). In case the current
COVID-19 circumstances allow it, subjects may be offered to come to the
research facility to explain all study procedures and for product pick-up -
alternatively, information will be given online and the product will be sent by
mail. Possible risks relate to eventual changes in side-effects generally
associated with changes in fibre intake (e.g., bloating, flatulence etc). Yet,
these risks are expected to be minimal due to the consumption of the vegetable
product split into two daily portions and, if symptoms occur, cessation of
these symptoms is expected over the course of the study due to the adaptation
of the gut to the increased fibre intake. Hence, the risk associated with
participation and the burden is minimal.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
• 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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80274.091.22 |
| Other | registratie in clinicaltrial.gov NCT05473793 |