Clinical trial NCT03974477: Study With an Innovative Equipment to Monitor and Control SALT During Cooking
Official title: Randomized Controlled Trial With SALT CONTROL H - Impact on Individual Sodium and Sodium to Potassium Ratio Excretion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Salt; Excess
Hypertension
Keywords: Dietary Salt
Urinary sodium excretion
Cooking
Hypertension
Randomized Controlled Trial
Sodium
Diet
Patient Education
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Instituto Nacional de Saúde Doutor Ricardo Jorge
name: Centro Hospitalar De São João, E.P.E.
First posted: 2019-06-05
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline 24h urinary sodium excretion at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Secondary outcomes:
measure: Change from Baseline 24h urinary potassium excretion at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Systolic Blood Pressure at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Diastolic Blood Pressure at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Hydration Status at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Perception of quality of life at during and after intervention
timeFrame: Baseline, at 8th intervention week, and 6 months after intervention
measure: Change from Baseline Culinary competences at during and after intervention
timeFrame: Baseline, at 8th intervention week, and 6 months after intervention
measure: Change from Baseline Intestinal Microbiota at after intervention
timeFrame: Baseline and at 8th intervention week
measure: Change from Baseline Diet Quality at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Knowledges, attitudes and behaviours about salt at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Weight at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Height at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Fat Mass and Fat Free Mass at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Extra and intra cellular water at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Extra and intra cellular water at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
measure: Change from Baseline Basal Metabolic Rate at during and after intervention
timeFrame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Carla Gonçalves
Study officials:
affiliation: Researcher
name: Carla Gonçalves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.