Salt Consumption After the Administration of Rapid Questionnaire (MINISAL-SIIA STUDY) (MINISAL-SIIA)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Experimental dietary educational intervention

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 Type: Interventional
• Enrollment (Actual): 315
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; the Control group will not receive any additional information on diet
Experimental: Dietary educational intervention; 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.	Other: Experimental 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.; Other Names: Dietary educational intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Prof. Ferruccio Galletti

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: FedericoIIEC/5516

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No