search
Back to results

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

Primary Purpose

Salt; Excess, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
SALT CONTROL H equipment to control and monitor salt during cooking process
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Salt; Excess focused on measuring Dietary Salt, Urinary sodium excretion, Cooking, Hypertension, Randomized Controlled Trial, Sodium, Diet, Patient Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Carla Gonçalves

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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!".

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.

Outcomes

Primary Outcome Measures

Change from Baseline 24h urinary sodium excretion at during and after intervention
Sodium excretion as a proxy of dietary salt intake

Secondary Outcome Measures

Change from Baseline 24h urinary potassium excretion at during and after intervention
Urinary potassium excretion as a proxy of dietary potassium intake
Change from Baseline Systolic Blood Pressure at during and after intervention
Systolic blood pressure
Change from Baseline Diastolic Blood Pressure at during and after intervention
Diastolic blood pressure
Change from Baseline Hydration Status at during and after intervention
urinary osmolality (mOsm/kg)
Change from Baseline Perception of quality of life at during and after intervention
Questionnaire WHOQOL-BREF, results from 0 to 100, higher values represent better perception of quality of life
Change from Baseline Culinary competences at during and after intervention
Questionnaire, questions scales from 1 to 6 according to culinary competences, higher values represent better culinary competences
Change from Baseline Intestinal Microbiota at after intervention
OTU (operational taxonomy unit) analysis (%)
Change from Baseline Diet Quality at during and after intervention
HDI (Healthy Diet Indicator), HDI-2015 was calculated as the sum of 7 components (range 0-7) and was classified as follows: high adherence (met 6-7 components), moderate adherence (met 4-5 components), and low adherence (met 0-3 components)
Change from Baseline Knowledges, attitudes and behaviours about salt at during and after intervention
Questionnaire on Knowledge, Attitudes, Behavior toward Dietary Salt and Health from PAHO (n and %)
Change from Baseline Weight at during and after intervention
Weight in kilograms
Change from Baseline Height at during and after intervention
Height in meters
Change from Baseline Fat Mass and Fat Free Mass at during and after intervention
Fat mass (in kg), Fat free mass (in kg)
Change from Baseline Extra and intra cellular water at during and after intervention
Extra and intra cellular water, basal metabolic rate
Change from Baseline Extra and intra cellular water at during and after intervention
Extra and intra cellular water (in kg)
Change from Baseline Basal Metabolic Rate at during and after intervention
Basal metabolic rate (in kcal)

Full Information

First Posted
April 29, 2019
Last Updated
January 7, 2021
Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia, Instituto Nacional de Saúde Doutor Ricardo Jorge, Centro Hospitalar De São João, E.P.E.
search

1. Study Identification

Unique Protocol Identification Number
NCT03974477
Brief Title
Study With an Innovative Equipment to Monitor and Control SALT During Cooking
Acronym
iMC_SALT
Official Title
Randomized Controlled Trial With SALT CONTROL H - Impact on Individual Sodium and Sodium to Potassium Ratio Excretion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia, Instituto Nacional de Saúde Doutor Ricardo Jorge, Centro Hospitalar De São João, E.P.E.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salt; Excess, Hypertension
Keywords
Dietary Salt, Urinary sodium excretion, Cooking, Hypertension, Randomized Controlled Trial, Sodium, Diet, Patient Education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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!".
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SALT CONTROL H equipment to control and monitor salt during cooking process
Intervention Description
Participants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content.
Primary Outcome Measure Information:
Title
Change from Baseline 24h urinary sodium excretion at during and after intervention
Description
Sodium excretion as a proxy of dietary salt intake
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Secondary Outcome Measure Information:
Title
Change from Baseline 24h urinary potassium excretion at during and after intervention
Description
Urinary potassium excretion as a proxy of dietary potassium intake
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Systolic Blood Pressure at during and after intervention
Description
Systolic blood pressure
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Diastolic Blood Pressure at during and after intervention
Description
Diastolic blood pressure
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Hydration Status at during and after intervention
Description
urinary osmolality (mOsm/kg)
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Perception of quality of life at during and after intervention
Description
Questionnaire WHOQOL-BREF, results from 0 to 100, higher values represent better perception of quality of life
Time Frame
Baseline, at 8th intervention week, and 6 months after intervention
Title
Change from Baseline Culinary competences at during and after intervention
Description
Questionnaire, questions scales from 1 to 6 according to culinary competences, higher values represent better culinary competences
Time Frame
Baseline, at 8th intervention week, and 6 months after intervention
Title
Change from Baseline Intestinal Microbiota at after intervention
Description
OTU (operational taxonomy unit) analysis (%)
Time Frame
Baseline and at 8th intervention week
Title
Change from Baseline Diet Quality at during and after intervention
Description
HDI (Healthy Diet Indicator), HDI-2015 was calculated as the sum of 7 components (range 0-7) and was classified as follows: high adherence (met 6-7 components), moderate adherence (met 4-5 components), and low adherence (met 0-3 components)
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Knowledges, attitudes and behaviours about salt at during and after intervention
Description
Questionnaire on Knowledge, Attitudes, Behavior toward Dietary Salt and Health from PAHO (n and %)
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Weight at during and after intervention
Description
Weight in kilograms
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Height at during and after intervention
Description
Height in meters
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Fat Mass and Fat Free Mass at during and after intervention
Description
Fat mass (in kg), Fat free mass (in kg)
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Extra and intra cellular water at during and after intervention
Description
Extra and intra cellular water, basal metabolic rate
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Extra and intra cellular water at during and after intervention
Description
Extra and intra cellular water (in kg)
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Title
Change from Baseline Basal Metabolic Rate at during and after intervention
Description
Basal metabolic rate (in kcal)
Time Frame
Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Gonçalves, PhD
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carla Gonçalves
City
Porto
ZIP/Postal Code
4200-465
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
In order to promote the quality of the data, they will be introduced by an researcher with delegation of competences by the PI, a verification of double data entry and verification of outliers will be performed. The data will be used for publication of the results by the researchers of the project and for the accomplishment of master's and doctoral thesis.
Citations:
PubMed Identifier
27072344
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.
Results Reference
background
PubMed Identifier
25317121
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.
Results Reference
background
PubMed Identifier
29545733
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.
Results Reference
background
PubMed Identifier
32423935
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs