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Randomized Controlled Trial
. 2025 Mar;32(2):181-190.
doi: 10.1007/s40292-025-00704-1. Epub 2025 Jan 30.

"Minimal-Advice" on Salt Intake: Results of a Multicentre Pilot Randomised Controlled Trial on Hypertensive Patients

Lanfranco D'Elia  1 , Pasquale Strazzullo  2 , Antonio Del Giudice  3 , Giovambattista Desideri  4 , Rosario Di Quattro  5 , Claudio Ferri  6 , Alessandra Grossi  7 , Lorenzo Malatino  5 , Francesca Mallamaci  8 , Andrea Maresca  9 , Michele Meschi  10 , Alessia Casola  11 , Pietro Nazzaro  12 , Marco Pappaccogli  13 , Franco Rabbia  13 , Carla Sala  14 , Ferruccio Galletti  15 ; MINISAL-SIIA Study Group
Affiliations
Randomized Controlled Trial

"Minimal-Advice" on Salt Intake: Results of a Multicentre Pilot Randomised Controlled Trial on Hypertensive Patients

Lanfranco D'Elia et al. High Blood Press Cardiovasc Prev. 2025 Mar.

Abstract

Introduction: 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 behaviour about salt was directly interrelated, suggesting a key role of the educational approach.

Aim: The present multicentre randomised controlled trial study aimed to evaluate the efficacy of a short-time dietary educational intervention by a physician, only during the first visit, on sodium and potassium intake in hypertensive patients.

Methods: Two-hundred-thirty hypertensive subjects participating in the MINISAL-SIIA study were enrolled for this study. After the randomisation, the participants were stratified into the educational intervention (EI) group (n = 109) and control group (C) (n = 121). Anthropometric indexes and blood pressure (BP) measurements were taken in the single-centre, and 24-hour urinary sodium (UrNa) and potassium (UrK) excretion were centrally measured.

Results: After 3 months, there was a reduction in BP, UrNa, and body weight, and an increase in UrK in EI. By contrast, a lower decrease in BP was found in the C group, and a slight rise in UrNa and no substantial change in UrK were revealed. BP changes were positively and significantly associated with changes in UrNa only in EI.

Conclusion: The main results of this trial indicate that a single brief educational intervention by a physician can lead to a reduction in salt intake and BP, and increased potassium consumption in hypertensive patients, without adverse effects.

Trail registration: ClinicalTrial.gov registration number: NCT06651437.

Keywords: Dietary Questionnaire; Hypertension; Potassium; Salt; Salt Awareness; Salt Behaviour; Sodium; Urinary Potassium; Urinary Sodium.

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Conflict of interest statement

Declarations. Conflict of interest: The authors declare that they have no conflict of interest. Ethics Approval: The study protocol was approved by the local Ethics Committees (“Federico II” University of Naples - Ethics Committee, registration number: 55/16). Consent to Participate: All participants gave their written informed consent to participate in the study.

Figures

Fig. 1
Fig. 1
Twenty-four-hour urinary excretion of sodium (UrNa), potassium (UrK), and the UrNa/UrK ratio at baseline (T0), follow-up (T1), and their changes (Delta). C: Control; EI: educational intervention. Data were reported as median and standard error. The data were compared by the Wilcoxon test
See this image and copyright information in PMC

References

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