Randomized double blind placebo-controlled intervention study to investigate effects of VITACEL extrinsic wheat fibers for maintenance of normal defecation by increasing fecal bulk in healthy subjects
Phase 3
- Conditions
- Regular digestion
- Registration Number
- DRKS00026262
- Lead Sponsor
- J. Rettenmaier & Söhne GmbH + Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Good physical and mental health, stool frequency between 4 and 7 movements per week, BMI between 19 and 32 kg/m2, non-smoker, written consent to participate in the study
Exclusion Criteria
Mediacal disorders interfering with the study, subjects under prescription for medication or taking dietary supplements possibly interfering with this study, prior abdominal surgery, intake of antibiotics in the last 3 months prior to screening, use of pre- and probiotic supplements, subjects consuming food or drinks claimed as 'probiotic' or 'prebiotic', food or dinks claimed rich in fiber', more than 3 portions of fruits and vegetables (sum) per day, vegans and vegetarians, regular laxative use, regular stool consistency of diarrheal subtype
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fecal bulk; collection with a fecontainer and weighing with a digital scale over three weeks
- Secondary Outcome Measures
Name Time Method Stool frequency; app-based documentation of the stool frequency