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Disclosure of Genetic Risk for Salt Sensitivity

S

St Mary's University College

Status

Unknown

Conditions

Salt-sensitive Hypertension

Treatments

Behavioral: Dietary advice

Study type

Interventional

Funder types

Other

Identifiers

NCT03775720
SMEC_2017-18_142

Details and patient eligibility

About

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.

Full description

Salt sensitivity is a key risk factor for hypertension. However, population decrease in salt intake is less than optimal. Research suggests genetics-based personalised nutrition can positively impact health behaviours aiding in the prevention of chronic disease development. However, the effects of communicating such information are unclear. The aims of this study will be to analyse the impact of communicating genetic susceptibility to salt sensitivity on salt intake by assessing dietary salt intake before and after disclosure of genetic risk for hypertension according to the polymorphism in the SLC4A5. Participants will be normotensive, aged 18-35 years. All individuals will receive genetics-based personalised nutritional information. Participants displaying the risk genotype (AA + AC) will be advised to decrease salt intake to less than 4g/d and non-risk will be advised to adhere to government recommendations (6g/d). Dietary recall (24hrs) and 24-hour urine collection will be collected at baseline and four-weeks post-intervention to assess salt intake and excretion.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy males and females, aged 18-35

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Low genetic risk group
Experimental group
Description:
Dietary advice to maintain salt intake to 6g/day
Treatment:
Behavioral: Dietary advice
High genetic risk group
Experimental group
Description:
Dietary advice to reduce salt intake to 4g/day
Treatment:
Behavioral: Dietary advice

Trial contacts and locations

0

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Central trial contact

Leta Pilic

Data sourced from clinicaltrials.gov

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