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

NCT ID: NCT03974477

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Salt; Excess Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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!".

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role collaborator

Instituto Nacional de Saúde Doutor Ricardo Jorge

UNKNOWN

Sponsor Role collaborator

Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carla Gonçalves, PhD

Role: PRINCIPAL_INVESTIGATOR

Researcher

Locations

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Carla Gonçalves

Porto, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type BACKGROUND
PMID: 27072344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25317121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29545733 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32423935 (View on PubMed)

Other Identifiers

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iMCSALT19-21

Identifier Type: -

Identifier Source: org_study_id

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