NCT03775720

Brief Summary

The global burden of cardiovascular disease (CVD) has decreased over the past 10 years. Nevertheless, the disease still kills one in three people. Hypertension is one of the leading causes of cardiovascular disease, with salt in the diet being a main contributor. Depending on an individual's DNA, participants may or may not be salt sensitive. Genotyping individuals for variants in a salt sensitivity gene (SLC4A5) may identify salt sensitive individuals which may benefit from a personalised dietary advice to reduce salt intake. Adherence to such advice can then be assessed which may aid in prevention of hypertension and CVD.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

September 21, 2018

Last Update Submit

December 13, 2018

Conditions

Salt-sensitive Hypertension

Outcome Measures

Primary Outcomes (1)

  • Dietary salt intake

    24-hour recall

    1 month

Study Arms (2)

Low genetic risk group

EXPERIMENTAL

Dietary advice to maintain salt intake to 6g/day

Behavioral: Dietary advice

High genetic risk group

EXPERIMENTAL

Dietary advice to reduce salt intake to 4g/day

Behavioral: Dietary advice

Interventions

Dietary adviceBEHAVIORAL

Based on their genetic risk, participants are given advice to either adhere to general dietary guidelines related to salt intake or to reduce their salt intake to no more than 4 grams per day.

High genetic risk groupLow genetic risk group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males and females, aged 18-35

You may not qualify if:

  • pregnant, CVD events (Angina, myocardial infarction, heart failure) or stage 2, hypertension, a BMI ≥30kg/m2, or experiencing mental anguish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Leta Pilic

CONTACT

020 8240 4359leta.pilic@stmarys.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Administrator

Study Record Dates

First Submitted

September 21, 2018

First Posted

December 14, 2018

Study Start

February 1, 2019

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

December 14, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share