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

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (Other)

Overall Status

Completed

CT.gov ID

NCT02710513

Collaborator

University of Bari (Other)

Enrollment

Location

Arm

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Beta-glucans	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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)
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 gut microbiota IS modulation [at the end of the intervention period (2 months)]
Measurement of circulating levels of indoxyl 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOUC "Policlinico"	Bari		Italy	70124

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
University of Bari

Investigators

Principal Investigator: Loreto Gesualdo, MD Full Prof, Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico"