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| Name | Class |
|---|---|
| University of Bari | OTHER |
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The purpose of this study is to evaluate the healthy properties of a dietary intervention based on an innovative pasta enriched with prebiotic fibers (barley beta-glucans).
The hypothesis is that the gut microbiota and metabolome, the nutritional status, the redox/subclinical inflammation parameters and the markers of cardiovascular risk may improve in healthy subjects.
This clinical trial is a prospective pilot study, lasting 4 months. A target number of 30 healthy individuals meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-glucans | Experimental | 2 months run-in period (Mediterranean Diet-based dietary scheme including a daily supply of 100 g of normal pasta) + 2 months intervention period (Mediterranean Diet-based dietary scheme including a daily supply of 100 g of functional pasta providing 3 g of beta-glucans/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-glucans | Dietary Supplement | 2 months Mediterranean Diet-based free diet (run-in) + 2 months Mediterranean Diet-based free diet with a daily supplementation of 100 g of beta-glucans pasta (intervention). Medical visits, dietary counselling with food frequency questionnaires administration, blood, urine and feces collection were performed before (T0) and after (T2) the two months of beta-glucans intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in non-HDL cholesterol | Confirmation of beta-glucans properties in reduction of total and LDL cholesterol | at the end of the intervention period (2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on gut microbiota SCFA modulation | Measurement of fecal levels of short-chain fatty acids (acetate, propionate, butyrate) | at the end of the intervention period (2 months) |
| Effects on gut microbiota pCS modulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loreto Gesualdo, MD Full Prof | Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUC "Policlinico" | Bari | 70124 | Italy |
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| ID | Term |
|---|---|
| D047071 | beta-Glucans |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Measurement of circulating levels of p-cresyl sulphate
| at the end of the intervention period (2 months) |
| Effects on gut microbiota IS modulation | Measurement of circulating levels of indoxyl sulphate | at the end of the intervention period (2 months) |
| Effects on Flow-mediated dilation (FMD) | Measurement of beta-glucans effect on endothelial function through FMD | at the end of the intervention period (2 months) |