Gut microbiota
Conditions
Interventions
Group 1: 2 weeks Fructans (2.5 g/d) - 4 weeks wash-out - 2 weeks Placebo (2.5 g/d)
Group 2: 2 weeks Placebo (2.5 g/d) - 4 weeks wash-out - 2 weeks Fructans (2.5 g/d)
Sponsors
Beneo GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subject is in good physical and mental health as established by medical history and physical examination Men with typical Western style eating Patterns Age: 18-65 years BMI =18.5 and =35 kg/m² Nonsmoker and moderate smokers (maximal 10 cigarettes/day) Written informed consent to participate in the study Able and willing to follow the study protocol procedures
Exclusion criteria
Exclusion criteria: Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.) Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery Vegetarians, vegans Subjects who consume - Food or drinks claimed as ‘probiotic’, or ‘prebiotic’ more than once per week - Food or drinks claimed as ‘rich in fiber’ (including specific milk products) more than 3 times per week - More than 3 portions of fruits and vegetables per day (e.g. 2 portions of fruit and 1 portion of vegetables or 1 portion of fruit and 2 portions of vegetables) Subjects with stool frequency of = 2 stool every 7 days Subjects not willing to avoid pre- and probiotics for the duration of the study Regular intake of drugs or dietary supplements possibly interfering with this study (e.g. antispasmodics, laxatives, fibers, etc.) within 2 weeks prior to study start or during study Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study Intake of antibiotics in the last 2 months and laxatives in the last 2 weeks Known Food intolerance or allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bifidobacterium spp. in fecal samples before and after 2 weeks of Intervention. A Bifidobacteria-specific quantitative polymerase chain-reaction (qPCR) Assay will be used. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel function during intake periods will be assessed with an electronic Diary. | — |
Countries
Germany
Contacts
Public ContactTanita Dharsono
BioTeSys GmbH
Outcome results
None listed