ProAliFun_6.5_Health Effects of a Functional Pasta Enriched With Barley Beta-glucans on Healthy Subjects (ProAliFun65)

March 16, 2016 updated by: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • AOUC "Policlinico"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
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.
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
Time Frame: at the end of the intervention period (2 months)
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
Time Frame: at the end of the intervention period (2 months)
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
Time Frame: at the end of the intervention period (2 months)
Measurement of circulating levels of p-cresyl sulphate
at the end of the intervention period (2 months)
Effects on gut microbiota IS modulation
Time Frame: at the end of the intervention period (2 months)
Measurement of circulating levels of indoxyl sulphate
at the end of the intervention period (2 months)
Effects on Flow-mediated dilation (FMD)
Time Frame: at the end of the intervention period (2 months)
Measurement of beta-glucans effect on endothelial function through FMD
at the end of the intervention period (2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Collaborators

University of Bari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (ESTIMATE)

March 16, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ProAliFun_6.5_CE4372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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