Fiber Intake & Fecal Bulk Enhanced Response

Study Overview
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Brief Summary
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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.

Official Title
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Fiber Intake & Fecal Bulk Enhanced Response

Conditions
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Fecal Bulk, Intestinal Health

Intervention / Treatment
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* Other: High wheat fiber
* Other: Low fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Apparently healthy (no gastrointestinal complaints, no food allergies and no medication that can influence the outcome of this study Age range between 18-70 years old BMI between 20 and 30 kg/m2 Average fiber intake of <23grams 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high fibre<br>A 10 day increase in daily wheat fiber intake by 18-22 grams/day. Products are provided in boxes that must be consumed each day during the intervention. | Other: High wheat fiber<br>* Daily increased fiber intake by 18-22 grams/day. Products are provided in boxes that must be consumed each day during the intervention.<br>|
| Experimental: low fibre<br>A 10 day control intervention with no additional wheat fibre. Products are provided in boxes that must be consumed each day during the intervention. | Other: Low fiber<br>* Control low fiber intervention. Products are provided in boxes that must be consumed each day during the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal bulk | Wet and dry weight of stool samples in grams | last 5 days of each intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool consistency | by Bristol stool chart (type 1-7) | last 5 days of each intervention period | 
| gut-related complaints | 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 | last 5 days of each intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibre, diet, fecal bulk