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

NCT ID: NCT02710513

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Beta-glucans

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)

Group Type: EXPERIMENTAL

Beta-glucans

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Functional pasta enriched with barley beta-glucans

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bari

OTHER

Sponsor Role: collaborator

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loreto Gesualdo, MD Full Prof

Role: PRINCIPAL_INVESTIGATOR

Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico"

Locations

AOUC "Policlinico"

Bari, , Italy

Countries

Italy

Other Identifiers

ProAliFun_6.5_CE4372

Identifier Type: -

Identifier Source: org_study_id