Healthy
Conditions
Keywords
beta-glucans, gut microbiota, p-cresyl sulphate (pCS), indoxyl sulphate (IS), short-chain fatty acid (SCFA)
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBeta-glucans
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.
Sponsors
University of Bari
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy subjects * aged between 30 and 70 years * BMI between 18.5 and 24.9 * omnivorous diet * informed consent signed
Exclusion criteria
* diabetes type 2 * urine protein \> 1g/24h * antibiotics and probiotics administration by 15 days before the enrollment * gastrointestinal, celiac, inflammatory systemic and chronic liver diseases * recent diagnosis of cancer * corticosteroid or immunosuppressive therapies * previous major acute cardiovascular pathologies (heart attack, cerebral ictus) * hyperlipidemia * consume of alcohol * psychiatric diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in non-HDL cholesterol | at the end of the intervention period (2 months) | Confirmation of beta-glucans properties in reduction of total and LDL cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects on gut microbiota SCFA modulation | at the end of the intervention period (2 months) | Measurement of fecal levels of short-chain fatty acids (acetate, propionate, butyrate) |
| Effects on gut microbiota pCS modulation | at the end of the intervention period (2 months) | Measurement of circulating levels of p-cresyl sulphate |
| Effects on gut microbiota IS modulation | at the end of the intervention period (2 months) | Measurement of circulating levels of indoxyl sulphate |
| Effects on Flow-mediated dilation (FMD) | at the end of the intervention period (2 months) | Measurement of beta-glucans effect on endothelial function through FMD |
Countries
Italy
Outcome results
None listed