Intervention study to investigate effects of VITACEL® extrinsic wheat fibers incorporated in food products for maintenance of normal defecation by increase of fecal bulk in healthy subjects
- Conditions
- ormal defecation: Healthy subjects with 2-5 bowel movements/ week
- Registration Number
- DRKS00022855
- Lead Sponsor
- J. Rettenmaier & Söhne GmbH + Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 31
Subject is in good physical and mental health
Average fiber intake = 20 g/ day (during run-in phase)
-Stool frequency: 2 - 5 bowel movements per week
-BMI between 19.0 and 30.0 kg/m2
-Non-smoker
-Written consent to participate in the study
-Able and willing to follow the study procedures
-Relevant history or presence of any severe medical disorder, potentially interfering with this study in the investigator’s judgement
-Subject under prescription for medication or taking dietary supplements possibly interfering with this study within 2 weeks prior to study start or during the study (Stable medication (more than 3 months) for hypertension or thyroid gland is allowed)
-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’ more than once weekly
-Subjects consuming food or drinks claimed as ‘rich in fiber’ (including specific milk products) more than 3 times per week
-Subjects consuming more than 3 portions of fruits and vegetables (sum) per day
-Exclusively vegan or vegetarian diet
-Regular laxative use at least once per week
-Regular stool consistency of diarrheal subtype at least once every two weeks (Bristol stool scale type 5-7)
-Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to cooperate during the study
-No availability of a freezer with sufficient capacity to store the provided study foods
-Known pregnancy, breastfeeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1-4.
-Subjects with stool frequency of < 2 stools per week
-Known allergy to the test products
-Change of dietary habits within the 4 weeks prior to screening
-Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study
-Subject involved in any clinical or food study within the preceding month
-Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fecal Bulk (14 day before the intervention phases and in week 3/4 during the intervention phases)
- Secondary Outcome Measures
Name Time Method Stool frequency (baseline, week 1/2 and week 3/4), stool consistency (baseline, week 1/2 and week 3/4), gastrointestinal characteristics (baseline, week 1/2 and week 3/4), gastrointestinal condition (baseline and after the four week intervention phases), gut microbiota (16-rRNA analysis)(baseline and after the four week intervention phases)