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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
St Mary's University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Salt-sensitive Hypertension

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts 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.

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

    First Posted
    September 21, 2018
    Last Updated
    December 13, 2018
    Sponsor
    St Mary's University College
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    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

    Learn more about this trial

    Disclosure of Genetic Risk for Salt Sensitivity

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