Salt; ExcessiMC_SALTNCT03974477
Study With an Innovative Equipment to Monitor and Control SALT During Cooking
A study of Salt; Excess and Hypertension, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Salt; Excess, Hypertension
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial With SALT CONTROL H - Impact on Individual Sodium and Sodium to Potassium Ratio Excretion
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).
Read more
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
- Being tested
- SALT CONTROL H equipment to control and monitor salt during cooking process
- Keywords
- Dietary Salt, Urinary sodium excretion, Cooking, Hypertension, Randomized Controlled Trial, Sodium, Diet, Patient Education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SALT CONTROL H equipment to control and monitor salt during cooking processDevice
Participants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content.
| Study group | Role | What they receive |
|---|---|---|
| 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!". Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline 24h urinary sodium excretion at during and after intervention
Sodium excretion as a proxy of dietary salt intake
Measured: 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
Urinary potassium excretion as a proxy of dietary potassium intake
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Systolic Blood Pressure at during and after intervention
Systolic blood pressure
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Diastolic Blood Pressure at during and after intervention
Diastolic blood pressure
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Hydration Status at during and after intervention
urinary osmolality (mOsm/kg)
Measured: 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
Questionnaire WHOQOL-BREF, results from 0 to 100, higher values represent better perception of quality of life
Measured: Baseline, at 8th intervention week, and 6 months after intervention
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
Measured: Baseline, at 8th intervention week, and 6 months after intervention
Change from Baseline Intestinal Microbiota at after intervention
OTU (operational taxonomy unit) analysis (%)
Measured: Baseline and at 8th intervention week
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)
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
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 %)
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Weight at during and after intervention
Weight in kilograms
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Height at during and after intervention
Height in meters
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Fat Mass and Fat Free Mass at during and after intervention
Fat mass (in kg), Fat free mass (in kg)
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Extra and intra cellular water at during and after intervention
Extra and intra cellular water, basal metabolic rate
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Extra and intra cellular water at during and after intervention
Extra and intra cellular water (in kg)
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Basal Metabolic Rate at during and after intervention
Basal metabolic rate (in kcal)
Measured: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jun 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Salt; ExcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, National Health Institute Dr. Ricardo Jorge, Centro Hospitalar De São João, E.P.E.
- Responsible party
- Sponsor
- Investigators
- Carla Gonçalves, PhD, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974477
- Sponsor's protocol ID
- iMCSALT19-21
- Acronym
- iMC_SALT
- Status last verified
- Dec 2020
- First submitted
- 29 Apr 2019
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 27072344Goncalves 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.
PubMed 25317121Moreira 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.
PubMed 29545733Goncalves 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.
PubMed 32423935
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial With SALT CONTROL H - Impact on Individual Sodium and Sodium to Potassium Ratio Excretion
- ClinicalTrials.gov ID
- NCT03974477
- Acronym / sponsor ID
- iMC_SALT / iMCSALT19-21
- Conditions
- Salt; Excess, Hypertension
- Keywords
- Dietary Salt, Urinary sodium excretion, Cooking, Hypertension, Randomized Controlled Trial, Sodium, Diet, Patient Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, National Health Institute Dr. Ricardo Jorge, Centro Hospitalar De São João, E.P.E.
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: SALT CONTROL H equipment to control and monitor salt during cooking processThe 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 | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnant
- Subjects with kidney disease,
- Subjects with active infection with an impact on renal function,
- Subjects with urinary incontinence,
- Subjects with acute coronary syndrome,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SALT CONTROL H equipment to control and monitor salt during cooking processParticipants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content. | Device | Intervention |
Primary outcome
Change from Baseline 24h urinary sodium excretion at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Sodium excretion as a proxy of dietary salt intake
15 secondary outcomes
Change from Baseline 24h urinary potassium excretion at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Systolic Blood Pressure at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Diastolic Blood Pressure at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Hydration Status at during and after intervention
Time frame: 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
Time frame: Baseline, at 8th intervention week, and 6 months after intervention
Change from Baseline Culinary competences at during and after intervention
Time frame: Baseline, at 8th intervention week, and 6 months after intervention
Change from Baseline Intestinal Microbiota at after intervention
Time frame: Baseline and at 8th intervention week
Change from Baseline Diet Quality at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Knowledges, attitudes and behaviours about salt at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Weight at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Height at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Fat Mass and Fat Free Mass at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Extra and intra cellular water at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Extra and intra cellular water at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Change from Baseline Basal Metabolic Rate at during and after intervention
Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 27072344Goncalves 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.
- Background: PubMed 25317121Goncalves 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.
- Background: PubMed 29545733Moreira 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.
- Derived from this study: PubMed 32423935Goncalves 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Gonçalves, PhD principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Salt; Excess and Hypertension, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline 24h urinary sodium excretion at during and after intervention (time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974477, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.