Study With an Innovative Equipment to Monitor and Control SALT During Cooking

NCT03974477 | Unknown

• 1 other identifier: iMCSALT19-21
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the researchers will evaluate the efficacy of an intervention using the SALT CONTROL H instrument (an innovative equipment to monitor and control salt) in workers at the University of Porto to reduce dietary salt intake. This is a randomized clinical trial with intervention conducted according to good clinical practice guidelines. The researchers will randomize 260 workers who meet the eligibility criteria and are enrolled in occupational health appointments. Prior to the intervention, the informed consent of the participants will be obtained and those who agree to participate will be allocated randomly in one of the two arms of the study (control or intervention), with balance of baseline characteristics (sex and hypertension). The intervention will last for 8 weeks, an individual session of presentation of SALT CONTROL H will be carried out, with explanation of how the equipment works in the culinary preparation with an adequate salt content, will be used an illustrative video and recipes with an adequate salt content; use of SALT CONTROL H at home by the participant to control the use of salt during the cooking process; supervision and enhancement of the use of equipment; daily occurrence log; and the application of a satisfaction questionnaire on the use of SALT CONTROL H. A leaflet will also be delivered about "The new Food Wheel, a guide to the daily food choice!". Control Group: No intervention will be carried out except the provision of a leaflet on "The new Food Wheel, a guide to the daily food choice!" to the participants. Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention analysis will cover the following domains: urinary sodium excretion corresponding to a 24 hour urine collection as a proxy for salt intake; 24-hour urinary potassium excretion, sodium:potassium ratio, systolic and diastolic blood pressure, and anthropometric measurements. Urine samples will be collected according to standardized procedures and analyzed by a certified laboratory. Secondary data such as satisfaction questionnaire, daily use of equipment, iodine analysis of salt used and excreted in urine 24h, hydration status, analysis of quality of life and quality of diet will also be analyzed, as well as intestinal microbiota.

Conditions

Salt; Excess; Hypertension

Keywords

Dietary Salt; Urinary sodium excretion; Cooking; Hypertension; Randomized Controlled Trial; Sodium; Diet; Patient Education

Outcome Measures

Primary Outcomes (1)

• Change from Baseline 24h urinary sodium excretion at during and after intervention

  Sodium excretion as a proxy of dietary salt intake

  Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention

Secondary Outcomes (15)

• Change from Baseline 24h urinary potassium excretion at during and after intervention

  Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention

• Change from Baseline Systolic Blood Pressure at during and after intervention

  Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention

• Change from Baseline Diastolic Blood Pressure at during and after intervention

  Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention

• Change from Baseline Hydration Status at during and after intervention

  Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention

• Change from Baseline Perception of quality of life at during and after intervention

  Baseline, at 8th intervention week, and 6 months after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention will last for 8 weeks, an individual session of presentation of SALT CONTROL H will be carried out, with explanation of how the equipment works in the culinary preparation with an adequate salt content (will be used an illustrative video and recipes with an adequate salt content); use of SALT CONTROL H at home by the participant to control the use of salt during the cooking process; supervision and enhancement of the use of equipment; daily occurrence log; and the application of a satisfaction questionnaire on the use of SALT CONTROL H. A leaflet will also be delivered about "The new Food Wheel, a guide to the daily food choice!".

Device: SALT CONTROL H equipment to control and monitor salt during cooking process

Control

NO INTERVENTION

No intervention will be carried out except the provision of a leaflet on "The new Food Wheel, a guide to the daily food choice!" to the participants.

Interventions

SALT CONTROL H equipment to control and monitor salt during cooking process DEVICE

Participants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\> 18 years)
• Eat frequently cooked meals at home (\> 4 days a week, of which at least 3 Sundays / month)
• Have an occupational health appoitments at São João Hospital
• Reported motivation to control salt consumption

You may not qualify if:

• Pregnant
• Subjects with kidney disease,
• Subjects with active infection with an impact on renal function,
• Subjects with urinary incontinence,
• Subjects with acute coronary syndrome,
• Subjects with severe liver disease;
• Subjects with heart failure;
• Subjects who do not use salt for cooking;
• Subjects with hypotension;
• Subjects that work at Faculty that are the Sponsor of the study

Sponsors & Collaborators

• Universidade do Porto: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Instituto Nacional de Saúde Doutor Ricardo Jorge: collaborator
• Centro Hospitalar De São João, E.P.E.: collaborator

Study Sites (1)

Carla Gonçalves

Porto, 4200-465, Portugal

Location

Related Publications (4)

• Goncalves C, Abreu S, Padrao P, Pinho O, Graca P, Breda J, Santos R, Moreira P. Sodium and potassium urinary excretion and dietary intake: a cross-sectional analysis in adolescents. Food Nutr Res. 2016 Apr 11;60:29442. doi: 10.3402/fnr.v60.29442. eCollection 2016.

  PMID: 27072344 BACKGROUND

• Goncalves C, Monteiro S, Padrao P, Rocha A, Abreu S, Pinho O, Moreira P. Salt reduction in vegetable soup does not affect saltiness intensity and liking in the elderly and children. Food Nutr Res. 2014 Oct 6;58. doi: 10.3402/fnr.v58.24825. eCollection 2014.

  PMID: 25317121 BACKGROUND

• Moreira P, Sousa AS, Guerra RS, Santos A, Borges N, Afonso C, Amaral TF, Padrao P. Sodium and potassium urinary excretion and their ratio in the elderly: results from the Nutrition UP 65 study. Food Nutr Res. 2018 Feb 27;62. doi: 10.29219/fnr.v62.1288. eCollection 2018.

  PMID: 29545733 BACKGROUND

• Goncalves C, Silva-Santos T, Abreu S, Padrao P, Graca P, Oliveira L, Esteves S, Norton P, Moreira P, Pinho O. Innovative equipment to monitor and control salt usage when cooking at home: iMC SALT research protocol for a randomised controlled trial. BMJ Open. 2020 May 17;10(5):e035898. doi: 10.1136/bmjopen-2019-035898.

  PMID: 32423935 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Carla Gonçalves, PhD

  Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: June 5, 2019
• Study Start: June 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: January 8, 2021

Record last verified: 2020-12

Locations

PT (1)