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

NCT02710513 | Completed DMC

• 1 other identifier: ProAliFun_6.5_CE4372
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

beta-glucans; gut microbiota; p-cresyl sulphate (pCS); indoxyl sulphate (IS); short-chain fatty acid (SCFA)

Outcome Measures

Primary Outcomes (1)

• Reduction in non-HDL cholesterol

  Confirmation of beta-glucans properties in reduction of total and LDL cholesterol

  at the end of the intervention period (2 months)

Secondary Outcomes (4)

• Effects on gut microbiota SCFA modulation

  at the end of the intervention period (2 months)

• Effects on gut microbiota pCS modulation

  at the end of the intervention period (2 months)

• Effects on gut microbiota IS modulation

  at the end of the intervention period (2 months)

• Effects on Flow-mediated dilation (FMD)

  at the end of the intervention period (2 months)

Study Arms (1)

Beta-glucans

EXPERIMENTAL

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

Interventions

Beta-glucans 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.

Also known as: Functional pasta enriched with barley beta-glucans

Beta-glucans

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy subjects
• aged between 30 and 70 years
• BMI between 18.5 and 24.9
• omnivorous diet
• informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead
• University of Bari: collaborator

Study Sites (1)

AOUC "Policlinico"

Bari, 70124, Italy

Location

MeSH Terms

Interventions

beta-Glucans

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Study Officials

• Loreto Gesualdo, MD Full Prof

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 16, 2016
• Study Start: December 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

IT (1)