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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
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.
AOUC "Policlinico"
Bari, Italy
Reduction in non-HDL cholesterol
Confirmation of beta-glucans properties in reduction of total and LDL cholesterol
Time frame: at the end of the intervention period (2 months)
Effects on gut microbiota SCFA modulation
Measurement of fecal levels of short-chain fatty acids (acetate, propionate, butyrate)
Time frame: at the end of the intervention period (2 months)
Effects on gut microbiota pCS modulation
Measurement of circulating levels of p-cresyl sulphate
Time frame: at the end of the intervention period (2 months)
Effects on gut microbiota IS modulation
Measurement of circulating levels of indoxyl sulphate
Time frame: 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
Time frame: at the end of the intervention period (2 months)
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