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Completed

NCT Number: NCT02710513

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

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.

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Key information

Conditions

Healthy

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOUC "Policlinico"

Bari, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Functional pasta enriched with barley beta-glucans

Primary outcomes

  1. Reduction in non-HDL cholesterol

    Time frame: at the end of the intervention period (2 months)

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

Secondary outcomes

  1. Effects on gut microbiota SCFA modulation

    Time frame: at the end of the intervention period (2 months)

    Measurement of fecal levels of short-chain fatty acids (acetate, propionate, butyrate)

  2. Effects on gut microbiota pCS modulation

    Time frame: at the end of the intervention period (2 months)

    Measurement of circulating levels of p-cresyl sulphate

  3. Effects on gut microbiota IS modulation

    Time frame: at the end of the intervention period (2 months)

    Measurement of circulating levels of indoxyl sulphate

  4. Effects on Flow-mediated dilation (FMD)

    Time frame: at the end of the intervention period (2 months)

    Measurement of beta-glucans effect on endothelial function through FMD

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Collaborators

  • University of Bari

Registry information

Official study title

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

Acronym: ProAliFun65

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 16, 2016
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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