Normal defecation: Healthy subjects with 2-5 bowel movements/ week
Conditions
Interventions
Group 1: VITACEL® Wheat Fibers (dietary fibers), 12g/day, 4 weeks, fortyfied food products
Group 2: Non-fortyfied food (placebo), 4 weeks
Sponsors
J. Rettenmaier & Söhne GmbH + Co KG
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal Bulk (14 day before the intervention phases and in week 3/4 during the intervention phases) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany
Contacts
Public ContactAnnegret Stier
J. Rettenmaier & Söhne GmbH + Co KG
Outcome results
None listed