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

NCT06651437 | Completed DMC

• 1 other identifier: FedericoIIEC/5516
• Study Type: interventional
• Target: 315
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Systolic and Diastolic Blood Pressure (mmHg)

  3 months

Study Arms (2)

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.

Other: Experimental dietary educational intervention

Interventions

Experimental dietary educational intervention OTHER

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.

Also known as: Dietary educational intervention

Dietary educational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Ferruccio Galletti: lead

Related Publications (1)

• 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.

  PMID: 39883400 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: October 21, 2024
• Study Start: July 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: November 8, 2024

Record last verified: 2024-11