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

Healthy Clinical Trial

— ProAliFun65  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710513
• Other study ID #: ProAliFun_6.5_CE4372
• Status: Completed
• Phase: N/A
• First received: March 7, 2016
• Last updated: March 16, 2016
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Azienda Ospedaliero-Universitaria Consorziale
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Italy	AOUC "Policlinico"	Bari

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale	University of Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Effects on gut microbiota SCFA modulation	Measurement of fecal levels of short-chain fatty acids (acetate, propionate, butyrate)	at the end of the intervention period (2 months)	No
Secondary	Effects on gut microbiota pCS modulation	Measurement of circulating levels of p-cresyl sulphate	at the end of the intervention period (2 months)	No
Secondary	Effects on gut microbiota IS modulation	Measurement of circulating levels of indoxyl sulphate	at the end of the intervention period (2 months)	No
Secondary	Effects on Flow-mediated dilation (FMD)	Measurement of beta-glucans effect on endothelial function through FMD	at the end of the intervention period (2 months)	No