Technological and Clinical Innovative Protocols for the Production of Functional Foods - 6.5 (ProAliFun65)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Reduction in non-HDL cholesterol
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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
- Effects on gut microbiota IS modulation(at the end of the intervention period (2 months))
- Effects on gut microbiota pCS modulation(at the end of the intervention period (2 months))
- Effects on Flow-mediated dilation (FMD)(at the end of the intervention period (2 months))
- Effects on gut microbiota SCFA modulation(at the end of the intervention period (2 months))