Investigate if an increased consumption of VITACEL Wheat Fiber can enhance fecal bulk. Furthermore, we want to demonstrate that the increased consumption of wheat fiber can increase stool frequency and consistency.
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal motility and defaecation conditions
Synonym
Health condition
het gaat hier niet zozeer om aandoeningen aan het maag-/darmstelsel, maar de interventie is gericht op het verbeteren van de stoelgang
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primairy study parameter is change in fecal bulk between a *low fiber*
intervention (with control products) and the wheat fiber enriched product
intervention.
Secondary outcome
Secondary parameters are stool consistency, gut-related complaints (e.g. stool
frequency, bloating, flatulence), appetite/satiety and food liking.
Background summary
Dietary fibre intake of the general population is much lower than recommended,
while consumption of fibres has many health benefits. Some dietary fibres,
including wheat fibres, have shown to increase fecal bulk and improve stool. In
previous studies, this effect on fecal bulk was especially studied for intact
wheat fibers. Moreover, in most studies, the wheat fiber was offered daily as a
single dose in cereals. In this study, we investigate whether an increased
intake of extracted wheat fiber (VITACEL Wheat Fiber, supplied by J.
Rettenmaier & Sohne GmbH & Co. KG), implemented at several time points in a
normal daily dietary pattern, can also increase fecal bulk and improve stool
frequency and consistency. VITACEL Wheat Fiber can be easily incorporated in
many food products, which might make it easier for the general population to
increase their dietary fibre intake, and subsequently improve their intestinal
health.
Study objective
Investigate if an increased consumption of VITACEL Wheat Fiber can enhance
fecal bulk. Furthermore, we want to demonstrate that the increased consumption
of wheat fiber can increase stool frequency and consistency.
Study design
The study is a double-blind crossover design in which participants receive
products enriched with VITACEL Wheat Fiber and control products. The
intervention products have almost identical taste, appearance and caloric
values. Both intervention periods are10 days with a wash-out period of at least
4 days.
Intervention
Subjects will be randomly assigned to the intervention groups; (*control *
*fiber-enriched OR *fiber-enriched * *control). In one of the intervention
periods participants receive *control boxes* with products low in wheat fiber
and in the other period they will receive boxes with products enriched with
VITACEL Wheat Fiber. During an intervention period of 10 days participants will
receive 10 boxes, one for each day, and they can choose themselves which box
they want on which day, except for day 1 and 2 (due to step-wise increase of
fiber intake). In the last 5 days of the intervention + 1 additional day after
the intervention (so in total 6 days), participants will collect their fecal
samples to analyse fecal bulk. Subjects will also keep a daily diary and fill
in questionnaires to check compliance to the intervention, to assess stool
consistency, gut-related complaints (e.g. stool frequency, bloating,
flatulence), appetite/satiety and food liking.
Study burden and risks
Participants only have to visit the research facility to collect the food
products, hand in collected fecal samples and have a final meeting with the
study MD. Most fecal samples will be collected at their houses to limit the
number of visits to the research facility. Consumption of the foods and fecal
collection will take place at home. Participants need keep a diary and fill in
questionnaires to report compliance and assess stool consistency, gut-related
complaints (e.g. stool frequency, bloating, flatulence), appetite/satiety and
food liking. Fiber intake will be gradually increase in the high fibre
intervention in order to addapt. No significant adverse effects from the
fiber-enriched diet are expected. Altogether, it is concluded that the risks
for the participants is negligible and the burdens are minimal. The increase
intake of fibre may even improve bowel function of some subjects. The FIBER
study is not group related.
Holzmuhle 1
Rosenberg 73494
DE
Holzmuhle 1
Rosenberg 73494
DE
Listed location countries
Age
Inclusion criteria
- Male
- Apparently healthy
- Age range between 18-70 years old
- BMI between 20 and 30 kg/m2
- Average fiber intake of 12-18 grams per day
- Living in the surrounding area of Wageningen (radius ~20 km)
Exclusion criteria
- Any digestive tract disorder that is expected to interfere with this study (e.g. (partial) gastric resection, (hemi)colectomy, Crohn*s disease, ulcerative colitis, irritable bowel disease, Coeliac disease)
- Known food allergy (e.g. lactose, gluten, nuts, egg, etc)
- Vegetarians
- Use of pro- or prebiotics
- Use of medication that can interfere with study outcomes (including laxatives, diuretics, antidepressants, codeine or antibiotics)
- Alcohol intake * 40g/day (* 3 glasses of beer/wine per day)
- Drug abuse
- Current smokers
- Participation in other clinical trials in the past month
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 | NL62342.081.17 |