NCT02710513

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Beta-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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2016-03-16
• Last updated: 2016-03-17

Locations

1 site across 1 country: Italy