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

Overview

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.

Full Title of Study: “Technological and Clinical Innovative Protocols for the Production of Functional Foods – 6.5 (ProAliFun65)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

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.

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.

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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)
  • 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
  • Effects on gut microbiota IS modulation
    • Time Frame: at the end of the intervention period (2 months)
    • Measurement of circulating levels of indoxyl sulphate
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Azienda Ospedaliero-Universitaria Consorziale
  • Collaborator
    • University of Bari
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Loreto Gesualdo, MD Full Prof, Principal Investigator, Head of the Nephrology, Dialysis and Transplantation Unit “Aldo Moro” University of Bari Azienda Ospedaliero-Universitaria Consorziale “Policlinico”

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