NCT03871374

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 4, 2019

Last Update Submit

March 11, 2019

Conditions

Salt Intake

Outcome Measures

Primary Outcomes (1)

  • Salt intake

    Dietary salt intake - two 24-hour recalls

    2 days observation

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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).

You may qualify if:

  • \- Males or females, aged 18-35 years and healthy.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's University

London, TW14SX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 12, 2019

Study Start

March 15, 2019

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)