Lysine-specific Demethylase 1 and Salt-sensitivity in Humans

November 18, 2025 updated by: Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital
The purpose of this study is to investigate the role dietary salt plays in epigenetic regulation of blood pressure, focusing on the salt-sensitive regulatory enzyme Lysine-specific demethylase 1.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to investigate the role dietary salt plays in epigenetic regulation of blood pressure in African American and Caucasians, focusing on the salt-sensitive regulatory enzyme Lysine-specific demethylase 1. This might help us understand why some people develop high blood pressure.

Healthy volunteers will be screened for eligibility and invited to participate in a 2 weeks study. Week 1 will be consumption of a low salt diet. Week 2 will be a high salt diet.

At the end of each week, participants will be admitted to a Clinical Research Center overnight and for one day.

On the CRC, participants will remain fasting and supine overnight and then next morning undergo hormonal and vascular testing. This will consist of blood drawing, echocardiogram, vascular tonometry, and assessment of renal blood flow before and after a low-dose Angiotensin II infusion.

The study outcome will compare how variants in the LSD1 gene affect hormonal and vascular responses according to race. This information will help us determine why some races and genetic profiles are more susceptible to detrimental effects of salt in the diet while others are protected against these effects.

Study Type

Interventional

Enrollment (Estimated)

88

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 Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 25-45 years
  • Caucasian or African American
  • No gender preference (anticipate 50% female)
  • Normotensive (screening blood pressure <140/90 mmHg)
  • No history of hypertension, diabetes, stroke, coronary artery disease, kidney disease, cancer, thyroid disease, preeclampsia, or hospitalizations in 6 months
  • Normal screening laboratory values (CMP, TSH, A1c)
  • Normal ECG
  • BMI <25 kg/m2

Exclusion Criteria:

  • Pregnancy
  • Breast feeding
  • Any medication or herbal preparation
  • >6oz alcohol/week
  • Tobacco use
  • Illicit drug use
  • Chronic NSAID use
  • Recent steroid use (injected, inhaled, oral)
  • Decongestant use in the past 2 weeks
  • Known sensitivity to infused Angiotensin II or para-amino hippurate

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Afr-Amer risk allele
African Americans carrying the LSD1 affected allele
Other: Aldosterone response to AngII LS
Change in aldosterone from baseline to after Ang II infusion on a LS diet
Other: Renal blood flow response to salt
Change in renal blood flow: High salt to low salt diet
Other: Vascular Stiffness
Change in vascular stiffness, baseline compared to AngII
Placebo Comparator: Cauc risk allele
Caucasians carrying the LSD1 affected allele
Other: Aldosterone response to AngII LS
Change in aldosterone from baseline to after Ang II infusion on a LS diet
Other: Renal blood flow response to salt
Change in renal blood flow: High salt to low salt diet
Other: Vascular Stiffness
Change in vascular stiffness, baseline compared to AngII
Placebo Comparator: Afr-Amer non-risk allele
African Americans carrying the LSD1 non-risk allele
Other: Aldosterone response to AngII LS
Change in aldosterone from baseline to after Ang II infusion on a LS diet
Other: Renal blood flow response to salt
Change in renal blood flow: High salt to low salt diet
Other: Vascular Stiffness
Change in vascular stiffness, baseline compared to AngII
Placebo Comparator: Cauc non-risk allele
Caucasians carrying the LSD1 non-risk allele
Other: Aldosterone response to AngII LS
Change in aldosterone from baseline to after Ang II infusion on a LS diet
Other: Renal blood flow response to salt
Change in renal blood flow: High salt to low salt diet
Other: Vascular Stiffness
Change in vascular stiffness, baseline compared to AngII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aldosterone response to angiotensin II
Time Frame: After 1 week dietary salt manipulation
Change in aldosterone, baseline to after angiotensin II by genotype/race
After 1 week dietary salt manipulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal blood flow response to dietary salt
Time Frame: After 1 week dietary salt manipulation on both diets
Change in renal blood flow, high salt diet to low salt diet by genotype/race
After 1 week dietary salt manipulation on both diets
Vascular stiffness response to angiotensin II
Time Frame: After 1 week dietary salt manipulation
Change in vascular stiffness, baseline to after angiotensin II by genotype/race
After 1 week dietary salt manipulation

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 2, 2017

Primary Completion (Actual)

January 2, 2022

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimated)

January 24, 2017

Study Record Updates

Last Update Posted (Estimated)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P002540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared first thru the publication of research results in peer-review scientific journals by the study investigator. IPD will be made available upon reasonable request from bona fide research organizations in an effort to provide broader impact and enrich public health knowledge. Research volunteer PHI will not be shared, and all participant data will be de-identified and coded. Only encrypted and secure network exchanges will be used for data transfer. Cost sharing my be required in order prepare datasets.

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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