Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-03-02 @ 5:35 PM
Study NCT ID:
NCT03775720
Status:
UNKNOWN
Last Update Posted:
2018-12-14
First Post:
2018-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Disclosure of Genetic Risk for Salt Sensitivity
Sponsor:
St Mary's University College
Organization:
Study Overview
Official Title:
Does Disclosing Genetic Risk to Salt Sensitivity Increase Compliance to Personalised Dietary Recommendations?
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: