Disclosure of Genetic Risk for Salt Sensitivity

December 13, 2018 updated by: Kim Wright, St Mary's University College

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low genetic risk group
Dietary advice to maintain salt intake to 6g/day
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.
Experimental: High genetic risk group
Dietary advice to reduce salt intake to 4g/day
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary salt intake
Time Frame: 1 month
24-hour recall
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Mary's University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 14, 2018

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMEC_2017-18_142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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