HypertensionNCT03127553
ProAliFun_6.7_Health Effects of a Low-Salt Bread on Hypertensive Subjects (ProAliFun67)
A study testing Low-sodium diet with standard bread and Low-sodium diet with low-sodium bread in people with Hypertension, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
The purpose of this clinical study is to evaluate the health properties of a dietary intervention carried on with an innovative low-salt bread. The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may improve the compliance to the own regime and that the vascular function, the… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Low-sodium diet with standard bread and Low-sodium diet with low-sodium bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Aug 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arterial hypertension stage I-II
- stable control of blood pressure
- eGFR > 60
- informed consent signed
Who cannot join
- uncontrolled hypertension
- therapy with diuretics
- need for therapy with more than three antihypertensive drugs
- proteinuria greater than 1 g/day
- celiac disease
- systemic inflammatory diseases
Show all 11Show fewer
- suspicion or clinical diagnosis of malignancy
- chronic liver disease
- treatment with corticosteroids or immunosuppressive drugs
- previous acute cardiovascular diseases (myocardial infarction, stroke)
- psychiatric conditions reducing the compliance to treatment protocols
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 - 6.7 (ProAliFun67)
The purpose of this clinical study is to evaluate the health properties of a dietary intervention carried on with an innovative low-salt bread.
The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may improve the compliance to the own regime and that the vascular function, the inflammatory and oxidative state, the composition of the intestinal microbiota and that neurocognitive and neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with low-salt bread.
Read the detailed description
This clinical trial is a multi-center, randomized, controlled, open label, pilot study, lasting 6 months.
A target number of seventy individuals with hypertension meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.
- Conditions
- Hypertension
- Being tested
- Low-sodium diet with standard bread, Low-sodium diet with low-sodium bread
- Keywords
- salt intake, functional food, low-salt bread, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-sodium diet with standard breadDietary supplement
low-sodium diet (2300 mg Na/die) with use of standard bread (750 mg Na/100g) for 6 months
Low-sodium diet with low-sodium breadDietary supplement
low-sodium diet (2300 mg Na/die) with use of low-salt bread (280 mg Na/100g) for 6 months
| Study group | Role | What they receive |
|---|---|---|
| A - control | No intervention | Free diet with standard bread |
| B - low-salt diet with normal bread | Active comparator | Low-sodium diet with standard bread Receives: Dietary Supplement: Low-sodium diet with standard bread |
| C - low-salt diet with low-salt bread | Experimental | Low-sodium diet with low-sodium bread Receives: Dietary Supplement: Low-sodium diet with low-sodium bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium intake
Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread
Measured: 6 months
Secondary outcomes (6)
Blood pressure
Reduction of blood pressure
Measured: 6 months
Endothelial stress
Improvement of flow-mediated dilation FMD
Measured: 6 months
Gut microbiota
Evaluation of gut microbiota modulation
Measured: 6 months
Antioxidant status
Evaluation of the antioxidant/oxidant ratio of blood
Measured: 6 months
Inflammation
State of sub-clinical inflammation
Measured: 6 months
Insulin sensitivity
Reduction of insulin sensitivity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startDec 2014
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedali Riuniti di Foggia
- 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
- NCT03127553
- Sponsor's protocol ID
- ProAliFun_6.7_CE4373
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cosola C, Pesce F, De Angelis M, Maranzano V, Zito A, Montemurno E, Dalfino G, Loiudice S, Creanza V, Pompa G, Ciccone MM, Grandaliano G, Stallone G, Gesualdo L. Effects of low-sodium bread on dietary compliance and fecal cultivable bacteria in a randomized controlled pilot trial in hypertensive subjects. BMC Nutr. 2024 Feb 21;10(1):31. doi: 10.1186/s40795-024-00838-w.
PubMed 38383476
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. 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 - 6.7 (ProAliFun67)
- ClinicalTrials.gov ID
- NCT03127553
- Acronym / sponsor ID
- ProAliFun_6.7_CE4373
- Conditions
- Hypertension
- Keywords
- salt intake, functional food, low-salt bread, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- Ospedali Riuniti di Foggia
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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 clinical study is to evaluate the health properties of a dietary intervention carried on with an innovative low-salt bread.
The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may improve the compliance to the own regime and that the vascular function, the inflammatory and oxidative state, the composition of the intestinal microbiota and that neurocognitive and neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with low-salt bread.
Detailed description
This clinical trial is a multi-center, randomized, controlled, open label, pilot study, lasting 6 months.
A target number of seventy individuals with hypertension meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - control | No intervention | –Free diet with standard bread |
| B - low-salt diet with normal bread | Active comparator | Dietary Supplement: Low-sodium diet with standard breadLow-sodium diet with standard bread |
| C - low-salt diet with low-salt bread | Experimental | Dietary Supplement: Low-sodium diet with low-sodium breadLow-sodium diet with low-sodium bread |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- arterial hypertension stage I-II
- stable control of blood pressure
- eGFR > 60
- informed consent signed
Key exclusion criteria (11 listed)
- uncontrolled hypertension
- therapy with diuretics
- need for therapy with more than three antihypertensive drugs
- proteinuria greater than 1 g/day
- celiac disease
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 |
|---|---|---|
| Low-sodium diet with standard breadlow-sodium diet (2300 mg Na/die) with use of standard bread (750 mg Na/100g) for 6 months | Dietary supplement | B - low-salt diet with normal bread |
| Low-sodium diet with low-sodium breadlow-sodium diet (2300 mg Na/die) with use of low-salt bread (280 mg Na/100g) for 6 months | Dietary supplement | C - low-salt diet with low-salt bread |
Primary outcome
Sodium intake
Time frame: 6 months
Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread
6 secondary outcomes
Blood pressure
Time frame: 6 months
Endothelial stress
Time frame: 6 months
Gut microbiota
Time frame: 6 months
Antioxidant status
Time frame: 6 months
Inflammation
Time frame: 6 months
Insulin sensitivity
Time frame: 6 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 25 Apr 2017.
- Derived from this study: PubMed 38383476Cosola C, Pesce F, De Angelis M, Maranzano V, Zito A, Montemurno E, Dalfino G, Loiudice S, Creanza V, Pompa G, Ciccone MM, Grandaliano G, Stallone G, Gesualdo L. Effects of low-sodium bread on dietary compliance and fecal cultivable bacteria in a randomized controlled pilot trial in hypertensive subjects. BMC Nutr. 2024 Feb 21;10(1):31. doi: 10.1186/s40795-024-00838-w.
- Individual participant dataSharing planned: No
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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 Low-sodium diet with standard bread and Low-sodium diet with low-sodium bread in people with Hypertension, 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 4 inclusion and 11 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 25 Apr 2017. 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?
Sodium intake (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03127553, which also lists 1 linked publication.
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 25 Apr 2017.