A low frequency of defecation (constipation) is a common complaint affecting a large part of the population. Children, adults and elderly can experience chronic inconvenience because of this complaint. Inulin is not digested in the human…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Trage stoelgang
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary question is: does inulin consmption increase the defecation
frequency as compoared with the placebo. This frequency is assessed by a bowel
habit questionnaire filled in by the participants at certain times during each
treatment.
Secondary outcome
Secondary outcomes are the effect of inulin on gastrointestinal comfort
(flatulence etc.) and on quality of life.
Background summary
Inulin occurs as a carbohydrate in a variety of plants: onion, garlic, wheat,
Jerusalem artichoke and chicory, that all belong to our daily nutrition. Sensus
(part od Royal Cosun) manyfactures inulin from chicory roots. This product with
the brand name Frutafit is sold world wide to the food industry for application
in virtually all market segments, but especially in dairy and bakery, in infant
food, in breakfast cereals and ceral bars, in beverages, but also in meat
products and in suaces and dressing it finds applications.
In these applications inulin is used not only to increase the dietary fibre
conntent, but also as a sugar and fat replacer, as a texturising agent and for
its prebiotic properties. For these and other health effects to be used as
health claims on foods a solid scienitific basis is required.
Study objective
A low frequency of defecation (constipation) is a common complaint affecting a
large part of the population. Children, adults and elderly can experience
chronic inconvenience because of this complaint. Inulin is not digested in the
human gastrointestinal tract and it is therefore considered a soluble dietary
fibre. These food ingredients are well known for their positive effects on
bowel habit.
Ths research is set up to show that consumption of inulin can improve the bowel
habit in slightly constipated elderly.
Study design
The study will be a cross-over, placebo controlled study. Each treatment will
last 5 weeks with a wash-out period of 2 weeks in between. The participants
receive a dosage of 2 times 5 gram inulin or maltodextrin (placebo) per day in
a drink and as a powder in a sachet; hence the total inulin or placebo
consumption will be 10 g/d.
Intervention
Once a day people consume an orange juice drink with 5 g of inulin or placebo
maltodextrin, and once a dya they use a powder (mixed with for instance coffe
or tea) of 5 g inulin or placebo during 5 weeks per treastment. Hence the total
consumption will be 10 g/day or inulin or placebo. A wash-out period of 2 weeks
in between treatments will be used.
Study burden and risks
The burden and risks are very limited: inulin and the placebo are components of
our daily diet. Inulin is used already for about 20 years as an ingredient in
food industry without complications. This research does not use any invasive
measures and the volunteers can stick to their normal dietary habits and
lifestyle. The burden involves only the discipline to consume for 2 x 5 weeks
an inulin- or placebo containing drink, and to use a powder product. Filling in
the bowel habit and QoL questonnaires does not take much time.
In very rare cases an allergic reaction to inuln-containing products has been
reported, but the risk for such an event is extremely low.
Borchwerf 3
4704 RG Roosendaal
Nederland
Borchwerf 3
4704 RG Roosendaal
Nederland
Listed location countries
Age
Inclusion criteria
Low defecation frequency (max 3 times per week), age between 50 - 75 y
Exclusion criteria
Use of laxatives
Design
Recruitment
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 | NL27269.003.09 |