Disclosure of Genetic Risk for Salt Sensitivity

NCT ID: NCT03775720

Last Updated: 2018-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-04-01

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.

Detailed 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.

Conditions

Salt-sensitive Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low genetic risk group

Dietary advice to maintain salt intake to 6g/day

Group Type: EXPERIMENTAL

Dietary advice

Intervention Type: BEHAVIORAL

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 group

Dietary advice to reduce salt intake to 4g/day

Group Type: EXPERIMENTAL

Dietary advice

Intervention Type: BEHAVIORAL

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.

Interventions

Dietary advice

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St Mary's University College

OTHER

Sponsor Role: lead

Responsible Party

Kim Wright

Research Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Leta Pilic

Role: CONTACT

leta.pilic@stmarys.ac.uk

020 8240 4359

Other Identifiers

SMEC_2017-18_142

Identifier Type: -

Identifier Source: org_study_id