About this trial
This study assesses the effects of an oral nutritional supplement (ONS) with fibre compared to a non-fibre containing ONS equal in energy and protein content on gut microbiota bifidobacteria in older adults with or at risk of disease related malnutrition. It is a randomised controlled, double blind, parallel-group, multi-country study. Subjects will receive an ONS with or without (control group) fibre. They take it twice a day for 4 weeks and the change in their gut microbiota bifidobacterial levels is the primary outcome. They will be measured at day 1 (V1), day 15 (V2) and week 4 (V3).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
1. Requirement for a fibre-free diet. 2. Have used nutritional supplements with fibre/prebiotics and/or probiotics content at any point during 3 weeks prior to start study (Visit 1) and / or will not refrain from using these kinds of products during the study period.
Trial design
Parallel
Treatments tested in this trial
Fibre drink
Dietary supplementOne drink will be tested
Treatment groups
Trial outcomes
Primary outcomes
Changes in gut microbiota bifidobacterial levels
Secondary outcomes
Changes in gut microbiota composition
Fecal pH
Stool frequency and consistency assessed by the Bristol Stool Form Scale (BSFS)
Total short-chain fatty acids (SCFA)
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: