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Prebiotic effect of Inulin-type fructans

Not Applicable
Conditions
Gut microbiota
Registration Number
DRKS00020887
Lead Sponsor
Beneo GmbH
Brief Summary

Inulin and oligofructose are prebiotic dietary fibers which affect gut microbiota and thereby host health. We aimed to demonstrate that 2.5 g/d oligofructose can lead to a significant increase in bifidobacteria thereby contributing to host health. 64 volunteers were randomized to consume 2.5 g/d Orafti® oligofructose or placebo for 14 days followed by a 4 week wash-out period and then crossed-over to the other intervention. Bifidobacteria and affect were assessed at the beginning and end of each intervention period. Furthermore, digestive function was documented daily. Bifidobacterium spp. increased significantly upon 2.5 g/d oligofructose intake compared to placebo (p = 0.016). Furthermore, stool frequency significantly increased during oligofructose compared to placebo (p = 0.0204) intake. With respect to affect, no significant changes were observed. This study is the first to demonstrate a significant increase in bifidobacteria coinciding with increased stool frequency after a very low dose of 2.5 g/d chicory oligofructose.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Male
Target Recruitment
64
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

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Bowel function during intake periods will be assessed with an electronic Diary.
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