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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Beta-glucans

Study type: Interventional

Funder types: Other

Identifiers

NCT02710513

ProAliFun_6.5_CE4372

Details and patient eligibility

About

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 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.

Enrollment: 28 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Beta-glucans

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Beta-glucans