Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG, Netherlands
NCT Number: NCT03313440
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, implemented at several time points in a normal daily dietary pattern, can also increase fecal bulk and improve stool frequency and consistency. Here we want to demonstrate that an increase in VITACEL Wheat Fiber intake will enhance fecal bulk, both wet and dry weight and that the enhanced wheat fiber intake will also increase stool frequency and consistency. The study is a double-blind crossover design in which the intervention is based on products enriched by VITACEL Wheat Fiber and control products. Both the control and fiber-enriched intervention will last for 10 days with a wash-out period of at least 4 days. The study will be conducted with 25 healthy male human volunteers in the age between 18-70 years old.Persons will be assigned to the intervention groups. 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. 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. Daily also a diary has to be kept and questionnaires have to be completed to check compliance to the intervention and assess stool consistency, gut-related complaints.
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Notify Me18 year–70 year
Male
Interventional
Not applicable
Wageningen, Gelderland, 6708 WG, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily increased fiber intake by 18-22 grams/day. Products are provided in boxes that must be consumed each day during the intervention.
Control low fiber intervention. Products are provided in boxes that must be consumed each day during the intervention.
Time frame: last 5 days of each intervention period
Wet and dry weight of stool samples in grams
Time frame: last 5 days of each intervention period
by Bristol stool chart (type 1-7)
Time frame: last 5 days of each intervention period
by questionnaires and Visual Analogue Scale (VAS) scores (on a 90mm horizontal line; from no complains (minimal) to serious complains (maximum)). Higher values represent a worse outcome
Wageningen University and Research
Other
Acronym: Fiber
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