Disclosure of Genetic Risk for Salt Sensitivity

Salt-sensitive Hypertension Clinical Trial

Official title:

Does Disclosing Genetic Risk to Salt Sensitivity Increase Compliance to Personalised Dietary Recommendations?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03775720
• Other study ID #: SMEC_2017-18_142
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: April 1, 2019

Study information

• Verified date: December 2018
• Source: St Mary's University College
• Contact: Leta Pilic
• Phone: 020 8240 4359
• Email: leta.pilic[@]stmarys.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Salt-sensitive Hypertension

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St Mary's University College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary salt intake	24-hour recall	1 month