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| Name | Class |
|---|---|
| Democritus University of Thrace | OTHER |
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The purpose of this clinical trial was to evaluate the effects Lactococcus cremoris spp. im-mobilized on oat flakes on human microbiome and blood and urine biomarkers of associated with human health.
All eligible and consenting individuals were assigned a unique code for identification purposes. They were then randomly assigned to either the probiotic or placebo group. The probiotic group received oat flakes containing immobilized Lactococcus cremoris, while the placebo group received oat flakes indistinguishable in color, smell, and taste from the flakes with immobilized probiotics.Participants received written instructions on storing the product, which required refrigeration. They were instructed to consume 5 g of oats daily with a meal, ensuring the meal's temperature remained below 35 °C and was non-acidic (e.g., with yogurt). Biological samples were collected at three time points; before intervention, at 6th and 12th week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional oat flakes-placebo | Placebo Comparator |
| |
| Probiotic oat flakes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic oat flakes | Other | 2 x 10^9 cfu/g Lactococcus cremoris immobilized on oat flakes |
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| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory biomarkers | Change from baseline of hs-CRP and IL-6 | Blood samples were collected by venipuncture at three time points; before intervention, at 6th and 12th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Aegean | Myrina | Limnos/Lesvos | 81 400 | Greece |
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| Conventional oat flakes | Other | Commercial oat flakes |
|