Disclosure of Genetic Risk for Salt Sensitivity
Primary Purpose
Salt-sensitive Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary advice
Sponsored by
About this trial
This is an interventional prevention trial for Salt-sensitive Hypertension
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low genetic risk group
High genetic risk group
Arm Description
Dietary advice to maintain salt intake to 6g/day
Dietary advice to reduce salt intake to 4g/day
Outcomes
Primary Outcome Measures
Dietary salt intake
24-hour recall
Secondary Outcome Measures
Full Information
NCT ID
NCT03775720
First Posted
September 21, 2018
Last Updated
December 13, 2018
Sponsor
St Mary's University College
1. Study Identification
Unique Protocol Identification Number
NCT03775720
Brief Title
Disclosure of Genetic Risk for Salt Sensitivity
Official Title
Does Disclosing Genetic Risk to Salt Sensitivity Increase Compliance to Personalised Dietary Recommendations?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Anticipated)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
April 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Mary's University College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salt-sensitive Hypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low genetic risk group
Arm Type
Experimental
Arm Description
Dietary advice to maintain salt intake to 6g/day
Arm Title
High genetic risk group
Arm Type
Experimental
Arm Description
Dietary advice to reduce salt intake to 4g/day
Intervention Type
Behavioral
Intervention Name(s)
Dietary advice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dietary salt intake
Description
24-hour recall
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leta Pilic
Phone
020 8240 4359
Email
leta.pilic@stmarys.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Disclosure of Genetic Risk for Salt Sensitivity
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