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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Beta-glucans

• Registration Number: NCT02710513
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Status Verified: 2016-03
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-16
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Beta-glucans	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)

Primary Outcome Measures

Name	Time	Method
Reduction in non-HDL cholesterol	at the end of the intervention period (2 months)	Confirmation of beta-glucans properties in reduction of total and LDL cholesterol

Secondary Outcome Measures

Name	Time	Method
Effects on gut microbiota IS modulation	at the end of the intervention period (2 months)	Measurement of circulating levels of indoxyl sulphate
Effects on gut microbiota pCS modulation	at the end of the intervention period (2 months)	Measurement of circulating levels of p-cresyl sulphate
Effects on Flow-mediated dilation (FMD)	at the end of the intervention period (2 months)	Measurement of beta-glucans effect on endothelial function through FMD
Effects on gut microbiota SCFA modulation	at the end of the intervention period (2 months)	Measurement of fecal levels of short-chain fatty acids (acetate, propionate, butyrate)

Trial Locations

Locations (1)

AOUC "Policlinico"; 🇮🇹 Bari, Italy