HealthyProAliFun65NCT02710513
ProAliFun_6.5_Health Effects of a Functional Pasta Enriched With Barley Beta-glucans on Healthy Subjects
A study testing Beta-glucans in people with Healthy, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Beta-glucans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
- aged between 30 and 70 years
- BMI between 18.5 and 24.9
- omnivorous diet
- informed consent signed
Who cannot join
- 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
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- previous major acute cardiovascular pathologies (heart attack, cerebral ictus)
- hyperlipidemia
- consume of alcohol
- psychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technological and Clinical Innovative Protocols for the Production of Functional Foods - 6.5 (ProAliFun65)
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Beta-glucans
- Keywords
- beta-glucans, gut microbiota, p-cresyl sulphate (pCS), indoxyl sulphate (IS), short-chain fatty acid (SCFA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-glucansDietary supplement
Also called Functional pasta enriched with barley 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.
| Study group | Role | What they receive |
|---|---|---|
| Beta-glucans | Experimental | 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) Receives: Dietary Supplement: Beta-glucans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in non-HDL cholesterol
Confirmation of beta-glucans properties in reduction of total and LDL cholesterol
Measured: at the end of the intervention period (2 months)
Secondary outcomes (4)
Effects on gut microbiota SCFA modulation
Measurement of fecal levels of short-chain fatty acids (acetate, propionate, butyrate)
Measured: at the end of the intervention period (2 months)
Effects on gut microbiota pCS modulation
Measurement of circulating levels of p-cresyl sulphate
Measured: at the end of the intervention period (2 months)
Effects on gut microbiota IS modulation
Measurement of circulating levels of indoxyl sulphate
Measured: at the end of the intervention period (2 months)
Effects on Flow-mediated dilation (FMD)
Measurement of beta-glucans effect on endothelial function through FMD
Measured: at the end of the intervention period (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari
- Responsible party
- Sponsor
- Investigators
- Loreto Gesualdo, MD Full Prof, Principal investigator, Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710513
- Sponsor's protocol ID
- ProAliFun_6.5_CE4372
- Acronym
- ProAliFun65
- Status last verified
- Mar 2016
- First submitted
- 7 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technological and Clinical Innovative Protocols for the Production of Functional Foods - 6.5 (ProAliFun65)
- ClinicalTrials.gov ID
- NCT02710513
- Acronym / sponsor ID
- ProAliFun65 / ProAliFun_6.5_CE4372
- Conditions
- Healthy
- Keywords
- beta-glucans, gut microbiota, p-cresyl sulphate (pCS), indoxyl sulphate (IS), short-chain fatty acid (SCFA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- University of Bari
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beta-glucans | Experimental | Dietary Supplement: Beta-glucans2 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) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy subjects
- aged between 30 and 70 years
- BMI between 18.5 and 24.9
- omnivorous diet
- informed consent signed
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-glucansAlso: Functional pasta enriched with barley beta-glucans2 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. | Dietary supplement | Beta-glucans |
Primary outcome
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
4 secondary outcomes
Effects on gut microbiota SCFA modulation
Time frame: at the end of the intervention period (2 months)
Effects on gut microbiota pCS modulation
Time frame: at the end of the intervention period (2 months)
Effects on gut microbiota IS modulation
Time frame: at the end of the intervention period (2 months)
Effects on Flow-mediated dilation (FMD)
Time frame: at the end of the intervention period (2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loreto Gesualdo, MD Full Prof principal investigator
Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-glucans in people with Healthy, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in non-HDL cholesterol (time frame: at the end of the intervention period (2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.