Salt IntakeNCT03871374
Factors Affecting Salt Intake in Young Adults
An observational study of Salt Intake, run by St Mary's University College at 1 site in United Kingdom.
Trial summary
High salt intake is one of the key risk factors for development of high blood pressure and one of the main contributors to cardiovascular disease (CVD) mortality. Despite the efforts to reduce the intake of salt in the UK, current intake still exceeds the recommended values. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Salt Intake
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2019to 1 Sep 2019
- Phase
- Observational
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Hundred participants will be recruited based on their age and health status. In addition, this number is required to reach the adequate number of participants that has the genetic variation of interest (TRPV1 and SCNN1B genes).
Who may be able to join
- Males or females, aged 18-35 years and healthy.
Who cannot join
- Current stage 1 or 2 hypertension
- Current or recent (less than one month prior to screening visit) use of antihypertensive medications or medications that affect BP
- Secondary hypertension
- History of cardiovascular disease, including myocardial infarction, congestive heart failure, stroke, and peripheral arterial disease
- Chronic kidney failure
- Peptic ulcer disease requiring treatment during the previous two years
Show all 12Show fewer
- Currently pregnant women
- Underweight (BMI<18.5 kg/m2) and obese (BMI>30 kg/m2)
- Currently adhering to a low sodium diet
- Any illness that permanently alters taste
- Inability or unwillingness to participate or sign informed consent form
- Food allergy
Trial locations and contacts
1 site in 1 country.
About this study
High salt intake is one of the key risk factors for development of high blood pressure and one of the main contributors to cardiovascular disease (CVD) mortality. Despite the efforts to reduce the intake of salt in the UK, current intake still exceeds the recommended values. It is evident that better understanding of this behaviour is necessary to be able to design more effective CVD prevention strategies. This study aims to explore the determinants of salt intake with the focus on genetics, salt taste perception and salt knowledge.
Read the detailed description
Hypertension is a major cause of cardiovascular disease (CVD) and overall mortality. High dietary salt intake is a major risk factor for hypertension estimated to be responsible for one in ten deaths from CVD events. Salt consumption worldwide and in the UK exceeds the recommendations. One of the main determinants of food intake, and potentially salt, is taste which may be genetically determined. Research exploring the associations between genetics, salt taste and salt intake is scarce. Better understanding of these associations would be of specific interest in younger populations as it has been shown that it is the young adults that have higher preference for salty taste and consequently salt intake. Therefore, the aim of this study is to explore the associations between genetics, salt taste perception and salt intake in young UK adults.
One hundred participants (18-35 years) will be recruited. Salt taste thresholds will be identified using the British Standards Institution sensory analysis method (BS ISO 3972:2011) and preference for salty taste by rating the pleasantness and bitterness of six tomato soups with differing salt concentrations. Salt intake will be measured using five step multiple pass 24-hour recall completed via online platform (Online surveys) for one day of the week and one weekend day. Participants will be genotyped for genetic variants in the SCNN1B and TRPV1 genes coding for ion channels expressed in taste cells.
- Conditions
- Salt Intake
What is being measured
The primary outcome is the main question the study is designed to answer.
Salt intake
Dietary salt intake - two 24-hour recalls
Measured: 2 days observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start15 Mar 2019 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salt IntakeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871374
- Sponsor's protocol ID
- SMEC_2018-19_007
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Salt Intake in Young Adults
- ClinicalTrials.gov ID
- NCT03871374
- Acronym / sponsor ID
- SMEC_2018-19_007
- Conditions
- Salt Intake
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- 15 Mar 2019 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 12 Mar 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.
High salt intake is one of the key risk factors for development of high blood pressure and one of the main contributors to cardiovascular disease (CVD) mortality. Despite the efforts to reduce the intake of salt in the UK, current intake still exceeds the recommended values. It is evident that better understanding of this behaviour is necessary to be able to design more effective CVD prevention strategies. This study aims to explore the determinants of salt intake with the focus on genetics, salt taste perception and salt knowledge.
Detailed description
Hypertension is a major cause of cardiovascular disease (CVD) and overall mortality. High dietary salt intake is a major risk factor for hypertension estimated to be responsible for one in ten deaths from CVD events. Salt consumption worldwide and in the UK exceeds the recommendations. One of the main determinants of food intake, and potentially salt, is taste which may be genetically determined. Research exploring the associations between genetics, salt taste and salt intake is scarce. Better understanding of these associations would be of specific interest in younger populations as it has been shown that it is the young adults that have higher preference for salty taste and consequently salt intake. Therefore, the aim of this study is to explore the associations between genetics, salt taste perception and salt intake in young UK adults.
One hundred participants (18-35 years) will be recruited. Salt taste thresholds will be identified using the British Standards Institution sensory analysis method (BS ISO 3972:2011) and preference for salty taste by rating the pleasantness and bitterness of six tomato soups with differing salt concentrations. Salt intake will be measured using five step multiple pass 24-hour recall completed via online platform (Online surveys) for one day of the week and one weekend day. Participants will be genotyped for genetic variants in the SCNN1B and TRPV1 genes coding for ion channels expressed in taste cells.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Hundred participants will be recruited based on their age and health status. In addition, this number is required to reach the adequate number of participants that has the genetic variation of interest (TRPV1 and SCNN1B genes).
Key inclusion criteria (1 listed)
- Males or females, aged 18-35 years and healthy.
Key exclusion criteria (12 listed)
- Current stage 1 or 2 hypertension
- Current or recent (less than one month prior to screening visit) use of antihypertensive medications or medications that affect BP
- Secondary hypertension
- History of cardiovascular disease, including myocardial infarction, congestive heart failure, stroke, and peripheral arterial disease
- Chronic kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Salt intake
Time frame: 2 days observation
Dietary salt intake - two 24-hour recalls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Salt Intake
Enrolling by invitationObservational study
Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children
Urinary Sodium Excretion, Salt Intakes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salt Intake, run by St Mary's University College at 1 site in United Kingdom.
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 1 inclusion and 12 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 12 Mar 2019. 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 United Kingdom. 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?
Salt intake (time frame: 2 days observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2019; AzTrials last refreshed its copy on 3 Nov 2026.