ProAliFun_6.5_Health Effects of a Functional Pasta Enriched With Barley Beta-glucans on Healthy Subjects

Study Overview
=================
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.

Official Title
-----------------
Technological and Clinical Innovative Protocols for the Production of Functional Foods - 6.5 (ProAliFun65)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Beta-glucans


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta-glucans<br>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) | Dietary Supplement: Beta-glucans<br>* 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.<br>* Other names: Functional pasta enriched with barley beta-glucans;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
beta-glucans, gut microbiota, p-cresyl sulphate (pCS), indoxyl sulphate (IS), short-chain fatty acid (SCFA)