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

NCT02710513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-03-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • University of Bari

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    lead OTHER

Principal Investigators

  • Loreto Gesualdo, MD Full Prof · Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico"

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02710513 on ClinicalTrials.gov