The effect of wheat fiber on increase of fecal bulk

Completed

Conditions: het gaat hier niet zozeer om aandoeningen aan het maag-/darmstelsel, maar de interventie is gericht op het verbeteren van de stoelgang
improvement bowel function and defecation
10017977

Registration Number: NL-OMON44243

Lead Sponsor: J.Rettenmaier & Sohne GmbH & Co.KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primairy study parameter is change in fecal bulk between a low fiber<br /><br>intervention (with control products) and the wheat fiber enriched product<br /><br>intervention.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are stool consistency, gut-related complaints (e.g. stool<br /><br>frequency, bloating, flatulence), appetite/satiety and food liking. </p><br>