HypertensionMINISAL-SIIANCT06651437
Salt Consumption After the Administration of Rapid Questionnaire (MINISAL-SIIA STUDY)
A study testing Experimental dietary educational intervention in people with Hypertension, run by Prof. Ferruccio Galletti.
Trial summary
A strong and well-known association exists between salt consumption, potassium intake, and cardiovascular diseases. MINISAL-SIIA results showed high salt and low potassium consumption in Italian hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Experimental dietary educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult hypertensive patients with essential hypertension
- assessment of organ damage
- and stable antihypertensive treatment (lifestyle modifications and/or drug therapy) for at least 6 months
Who cannot join
- patients with alteration in nutritional and absorptive status
- glomerular filtration rate lower than 60 ml/min/1.73 m2
- personal history positive for a recent cardiovascular event (less than 6 months)
- atrial fibrillation or flutter, frequent atrial or ventricular premature contractions
About this study
Official title: A Nutritional Questionnaire in an Adult Italian Hypertensive Population: Effects on Sodium and Potassium Intake (MINISAL-SIIA STUDY)
A strong and well-known association exists between salt consumption, potassium intake, and cardiovascular diseases. MINISAL-SIIA results showed high salt and low potassium consumption in Italian hypertensive patients. In addition, a recent Italian survey showed that the degree of knowledge and behavior about salt was directly interrelated, suggesting a key role of the educational approach. Therefore, the present study will aim to evaluate the efficacy of a short-time dietary educational intervention (MINIMAL-ADVICE) on sodium and potassium intake in hypertensive patients.
Read the detailed description
High salt consumption is an important determinant of high blood pressure (BP) and cardiovascular diseases. Several intervention studies showed that a reduction in salt consumption reduces BP and can reduce cardiovascular risk beyond the beneficial effect on BP in people with and without hypertension. The World Health Organization (WHO) recommends that adults should consume no more than 5 g of salt daily. However, the mean daily intake of salt in the majority of countries worldwide exceeds this recommendation. In contrast to salt, epidemiological and intervention studies suggest beneficial effects of dietary potassium on BP and cardiovascular risk. This effect seems more pronounced during high salt consumption. The WHO currently also recommends that adults should consume not less than 90 mmol of potassium daily. However, also for potassium the WHO recommendations are not generally met.
Several countries have made some progress towards reducing habitual salt intake through a voluntary or regulatory approach, achieving a reduction of BP and cardiovascular disease in the young population. Our previous observational data detected that Italian general population samples consumed high dietary salt and low dietary potassium, far from the WHO guidelines recommendation. Excess dietary salt intake in the hypertensive patients' population was observed in all age categories and there were no differences in salt intake among different regions. Likewise, in the same hypertensive population the adequate potassium intake in both men and women, in all age categories, and in all the regions surveyed was much below the recommendation. These results point out the potential target to improve BP and cardiovascular risk, in particular in hypertensive patients. An Italian survey of a large cohort of the general population showed that the degree of knowledge and behaviour about salt was directly interrelated. These data suggested that educational approach is crucial to improve the level of salt consumption. The reduction of salt intake has been recommended by WHO as a cost-effective action that should be undertaken. Hence, an intervention study targeted to reduce dietary salt intake and also to increase dietary potassium consumption by an educational intervention is needed.
Given these premises, the aim of the present intervention study will be to evaluate the effect of a brief educational intervention "MINIMAL-ADVICE" for improving dietary salt and potassium intake in a hypertensive population. In addition, the effect of the educational intervention on BP in relation to the potential variation of salt and potassium intake will be also evaluated.
- Conditions
- Hypertension
- Being tested
- Experimental dietary educational intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental dietary educational interventionOther
Also called Dietary educational intervention
At the end of the baseline examination, the Experimental group received a brief dietary education on the health damage due to excess salt consumption and on behavioural methods to gradually reduce dietary intake, for example at home, reduce the consumption of processed foods, do not bring salt shaker on the table, limit the use of condiments with a high sodium content; out of home, both when eating and when shopping, reduce the consumption of processed foods, check nutritional labels and choose products with lower salt content. In addition, written information was provided. All participants will be clinically followed every month, with potential titration of the antihypertensive therapy. After 3 months of follow-up, the baseline measurements will be carried out again. During the entire study period, subjects will be asked to maintain their lifestyle and report using additional medications.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | the Control group will not receive any additional information on diet |
| Dietary educational intervention | Experimental | The dietary educational intervention group received dietary education to gradually reduce salt intake (a brief dietary education on the health damage due to excess salt consumption and on behavioural methods to gradually reduce dietary intake, for example at home, reduce the consumption of processed foods, do not bring salt shaker on the table, limit the use of condiments with a high sodium content; out of home, both when eating and when shopping, reduce the consumption of processed foods, check nutritional labels and choose products with lower salt content). In addition, written information was provided. Receives: Other: Experimental dietary educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Sodium and Potassium excretion (mmol/24h)
Urinary sodium and potassium concentrations (mmol/24h) were measured by ion selective electrode potentiometry and urinary creatinine by a kinetic Jaffe reaction using an ABX Pentra 400 apparatus (HORIBA ABX, Rome, Italy). Quality control was effected using urine-specific reference samples from UrichemGol BIODEV (Milan, Italy).
Measured: 3 months
Secondary outcomes (1)
Systolic and Diastolic Blood Pressure (mmHg)
Systolic and diastolic BP were measured with automatic validated devices, after having the participant sit for at least 10 minutes. Three measurements of BP and heart rate were made at 2-minute intervals with the patient in the sitting position, and the average of the second and third readings was recorded. In addition, two measurements were made after 2 minutes in the standing position
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Jul 2016
- Primary completion1 Jan 2022
- Study completion1 Jan 2023
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Ferruccio Galletti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Ferruccio Galletti, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651437
- Sponsor's protocol ID
- FedericoIIEC/5516
- Acronym
- MINISAL-SIIA
- Status last verified
- Nov 2024
- First submitted
- 5 Sep 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
D'Elia L, Strazzullo P, Del Giudice A, Desideri G, Di Quattro R, Ferri C, Grossi A, Malatino L, Mallamaci F, Maresca A, Meschi M, Casola A, Nazzaro P, Pappaccogli M, Rabbia F, Sala C, Galletti F; MINISAL-SIIA Study Group. "Minimal-Advice" on Salt Intake: Results of a Multicentre Pilot Randomised Controlled Trial on Hypertensive Patients. High Blood Press Cardiovasc Prev. 2025 Mar;32(2):181-190. doi: 10.1007/s40292-025-00704-1. Epub 2025 Jan 30.
PubMed 39883400
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional Questionnaire in an Adult Italian Hypertensive Population: Effects on Sodium and Potassium Intake (MINISAL-SIIA STUDY)
- ClinicalTrials.gov ID
- NCT06651437
- Acronym / sponsor ID
- MINISAL-SIIA / FedericoIIEC/5516
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Prof. Ferruccio GallettiUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 21 Oct 2024 (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.
A strong and well-known association exists between salt consumption, potassium intake, and cardiovascular diseases. MINISAL-SIIA results showed high salt and low potassium consumption in Italian hypertensive patients. In addition, a recent Italian survey showed that the degree of knowledge and behavior about salt was directly interrelated, suggesting a key role of the educational approach. Therefore, the present study will aim to evaluate the efficacy of a short-time dietary educational intervention (MINIMAL-ADVICE) on sodium and potassium intake in hypertensive patients.
Detailed description
High salt consumption is an important determinant of high blood pressure (BP) and cardiovascular diseases. Several intervention studies showed that a reduction in salt consumption reduces BP and can reduce cardiovascular risk beyond the beneficial effect on BP in people with and without hypertension. The World Health Organization (WHO) recommends that adults should consume no more than 5 g of salt daily. However, the mean daily intake of salt in the majority of countries worldwide exceeds this recommendation. In contrast to salt, epidemiological and intervention studies suggest beneficial effects of dietary potassium on BP and cardiovascular risk. This effect seems more pronounced during high salt consumption. The WHO currently also recommends that adults should consume not less than 90 mmol of potassium daily. However, also for potassium the WHO recommendations are not generally met.
Several countries have made some progress towards reducing habitual salt intake through a voluntary or regulatory approach, achieving a reduction of BP and cardiovascular disease in the young population. Our previous observational data detected that Italian general population samples consumed high dietary salt and low dietary potassium, far from the WHO guidelines recommendation. Excess dietary salt intake in the hypertensive patients' population was observed in all age categories and there were no differences in salt intake among different regions. Likewise, in the same hypertensive population the adequate potassium intake in both men and women, in all age categories, and in all the regions surveyed was much below the recommendation. These results point out the potential target to improve BP and cardiovascular risk, in particular in hypertensive patients. An Italian survey of a large cohort of the general population showed that the degree of knowledge and behaviour about salt was directly interrelated. These data suggested that educational approach is crucial to improve the level of salt consumption. The reduction of salt intake has been recommended by WHO as a cost-effective action that should be undertaken. Hence, an intervention study targeted to reduce dietary salt intake and also to increase dietary potassium consumption by an educational intervention is needed.
Given these premises, the aim of the present intervention study will be to evaluate the effect of a brief educational intervention "MINIMAL-ADVICE" for improving dietary salt and potassium intake in a hypertensive population. In addition, the effect of the educational intervention on BP in relation to the potential variation of salt and potassium intake will be also evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –the Control group will not receive any additional information on diet |
| Dietary educational intervention | Experimental | Other: Experimental dietary educational interventionThe dietary educational intervention group received dietary education to gradually reduce salt intake (a brief dietary education on the health damage due to excess salt consumption and on behavioural methods to gradually reduce dietary intake, for example at home, reduce the consumption of processed foods, do not bring salt shaker on the table, limit the use of condiments with a high sodium content; out of home, both when eating and when shopping, reduce the consumption of processed foods, check nutritional labels and choose products with lower salt content). In addition, written information was provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult hypertensive patients with essential hypertension
- assessment of organ damage
- and stable antihypertensive treatment (lifestyle modifications and/or drug therapy) for at least 6 months
Key exclusion criteria (4 listed)
- patients with alteration in nutritional and absorptive status
- glomerular filtration rate lower than 60 ml/min/1.73 m2
- personal history positive for a recent cardiovascular event (less than 6 months)
- atrial fibrillation or flutter, frequent atrial or ventricular premature contractions
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 |
|---|---|---|
| Experimental dietary educational interventionAlso: Dietary educational interventionAt the end of the baseline examination, the Experimental group received a brief dietary education on the health damage due to excess salt consumption and on behavioural methods to gradually reduce dietary intake, for example at home, reduce the consumption of processed foods, do not bring salt shaker on the table, limit the use of condiments with a high sodium content; out of home, both when eating and when shopping, reduce the consumption of processed foods, check nutritional labels and choose products with lower salt content. In addition, written information was provided. All participants will be clinically followed every month, with potential titration of the antihypertensive therapy. After 3 months of follow-up, the baseline measurements will be carried out again. During the entire study period, subjects will be asked to maintain their lifestyle and report using additional medications. | Other | Dietary educational intervention |
Primary outcome
Urinary Sodium and Potassium excretion (mmol/24h)
Time frame: 3 months
Urinary sodium and potassium concentrations (mmol/24h) were measured by ion selective electrode potentiometry and urinary creatinine by a kinetic Jaffe reaction using an ABX Pentra 400 apparatus (HORIBA ABX, Rome, Italy). Quality control was effected using urine-specific reference samples from UrichemGol BIODEV (Milan, Italy).
1 secondary outcome
Systolic and Diastolic Blood Pressure (mmHg)
Time frame: 3 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 8 Nov 2024.
- Derived from this study: PubMed 39883400D'Elia L, Strazzullo P, Del Giudice A, Desideri G, Di Quattro R, Ferri C, Grossi A, Malatino L, Mallamaci F, Maresca A, Meschi M, Casola A, Nazzaro P, Pappaccogli M, Rabbia F, Sala C, Galletti F; MINISAL-SIIA Study Group. "Minimal-Advice" on Salt Intake: Results of a Multicentre Pilot Randomised Controlled Trial on Hypertensive Patients. High Blood Press Cardiovasc Prev. 2025 Mar;32(2):181-190. doi: 10.1007/s40292-025-00704-1. Epub 2025 Jan 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental dietary educational intervention in people with Hypertension, run by Prof. Ferruccio Galletti.
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 3 inclusion and 4 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Urinary Sodium and Potassium excretion (mmol/24h) (time frame: 3 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 NCT06651437, 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 8 Nov 2024.