Healthy SubjectsNCT03029806
Lysine-specific Demethylase 1 and Salt-sensitivity in Humans
A study testing Aldosterone response to AngII LS, Renal blood flow response to salt and Vascular Stiffness in people with Healthy Subjects, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Aldosterone response to AngII LS, Renal blood flow response to salt and Vascular Stiffness
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2017to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Breast feeding
- Any medication or herbal preparation
- >6oz alcohol/week
- Tobacco use
- Illicit drug use
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- Aldosterone response to AngII LS, Renal blood flow response to salt, Vascular Stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldosterone response to AngII LSOther
Change in aldosterone from baseline to after Ang II infusion on a LS diet
Renal blood flow response to saltOther
Change in renal blood flow: High salt to low salt diet
Vascular StiffnessOther
Change in vascular stiffness, baseline compared to AngII
| Study group | Role | What they receive |
|---|---|---|
| Afr-Amer risk allele | Active comparator | African Americans carrying the LSD1 affected allele Receives: Other: Aldosterone response to AngII LS; Other: Renal blood flow response to salt; Other: Vascular Stiffness |
| Cauc risk allele | Placebo comparator | Caucasians carrying the LSD1 affected allele Receives: Other: Aldosterone response to AngII LS; Other: Renal blood flow response to salt; Other: Vascular Stiffness |
| Afr-Amer non-risk allele | Placebo comparator | African Americans carrying the LSD1 non-risk allele Receives: Other: Aldosterone response to AngII LS; Other: Renal blood flow response to salt; Other: Vascular Stiffness |
| Cauc non-risk allele | Placebo comparator | Caucasians carrying the LSD1 non-risk allele Receives: Other: Aldosterone response to AngII LS; Other: Renal blood flow response to salt; Other: Vascular Stiffness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aldosterone response to angiotensin II
Change in aldosterone, baseline to after angiotensin II by genotype/race
Measured: After 1 week dietary salt manipulation
Secondary outcomes (2)
Renal blood flow response to dietary salt
Change in renal blood flow, high salt diet to low salt diet by genotype/race
Measured: After 1 week dietary salt manipulation on both diets
Vascular stiffness response to angiotensin II
Change in vascular stiffness, baseline to after angiotensin II by genotype/race
Measured: After 1 week dietary salt manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start2 Jan 2017
- Primary completion2 Jan 2022
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Heathy volunteers
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029806
- Sponsor's protocol ID
- 2015P002540
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2017
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Krug AW, Tille E, Sun B, Pojoga L, Williams J, Chamarthi B, Lichtman AH, Hopkins PN, Adler GK, Williams GH. Lysine-specific demethylase-1 modifies the age effect on blood pressure sensitivity to dietary salt intake. Age (Dordr). 2013 Oct;35(5):1809-20. doi: 10.1007/s11357-012-9480-0. Epub 2012 Oct 2.
PubMed 23054827Williams JS, Chamarthi B, Goodarzi MO, Pojoga LH, Sun B, Garza AE, Raby BA, Adler GK, Hopkins PN, Brown NJ, Jeunemaitre X, Ferri C, Fang R, Leonor T, Cui J, Guo X, Taylor KD, Ida Chen YD, Xiang A, Raffel LJ, Buchanan TA, Rotter JI, Williams GH, Shi Y. Lysine-specific demethylase 1: an epigenetic regulator of salt-sensitive hypertension. Am J Hypertens. 2012 Jul;25(7):812-7. doi: 10.1038/ajh.2012.43. Epub 2012 Apr 26.
PubMed 22534796Pojoga LH, Williams JS, Yao TM, Kumar A, Raffetto JD, do Nascimento GR, Reslan OM, Adler GK, Williams GH, Shi Y, Khalil RA. Histone demethylase LSD1 deficiency during high-salt diet is associated with enhanced vascular contraction, altered NO-cGMP relaxation pathway, and hypertension. Am J Physiol Heart Circ Physiol. 2011 Nov;301(5):H1862-71. doi: 10.1152/ajpheart.00513.2011. Epub 2011 Aug 26.
PubMed 21873498Heydarpour M, Parksook WW, Pojoga LH, Williams GH, Williams JS. Mineralocorticoid Receptor and Aldosterone: Interaction Between NR3C2 Genetic Variants, Sex, and Age in a Mixed Cohort. J Clin Endocrinol Metab. 2024 Dec 18;110(1):e140-e149. doi: 10.1210/clinem/dgae127.
PubMed 38437868
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lysine-specific Demethylase 1 and Salt-sensitivity in Humans
- ClinicalTrials.gov ID
- NCT03029806
- Acronym / sponsor ID
- 2015P002540
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Heathy volunteers
| Arm | Type | Receives |
|---|---|---|
| Afr-Amer risk allele | Active comparator | Other: Aldosterone response to AngII LS, Other: Renal blood flow response to salt, Other: Vascular StiffnessAfrican Americans carrying the LSD1 affected allele |
| Cauc risk allele | Placebo comparator | Other: Aldosterone response to AngII LS, Other: Renal blood flow response to salt, Other: Vascular StiffnessCaucasians carrying the LSD1 affected allele |
| Afr-Amer non-risk allele | Placebo comparator | Other: Aldosterone response to AngII LS, Other: Renal blood flow response to salt, Other: Vascular StiffnessAfrican Americans carrying the LSD1 non-risk allele |
| Cauc non-risk allele | Placebo comparator | Other: Aldosterone response to AngII LS, Other: Renal blood flow response to salt, Other: Vascular StiffnessCaucasians carrying the LSD1 non-risk allele |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnancy
- Breast feeding
- Any medication or herbal preparation
- >6oz alcohol/week
- Tobacco use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aldosterone response to AngII LSChange in aldosterone from baseline to after Ang II infusion on a LS diet | Other | Afr-Amer non-risk allele, Afr-Amer risk allele, Cauc non-risk allele, Cauc risk allele |
| Renal blood flow response to saltChange in renal blood flow: High salt to low salt diet | Other | Afr-Amer non-risk allele, Afr-Amer risk allele, Cauc non-risk allele, Cauc risk allele |
| Vascular StiffnessChange in vascular stiffness, baseline compared to AngII | Other | Afr-Amer non-risk allele, Afr-Amer risk allele, Cauc non-risk allele, Cauc risk allele |
Primary outcome
Aldosterone response to angiotensin II
Time frame: After 1 week dietary salt manipulation
Change in aldosterone, baseline to after angiotensin II by genotype/race
2 secondary outcomes
Renal blood flow response to dietary salt
Time frame: After 1 week dietary salt manipulation on both diets
Vascular stiffness response to angiotensin II
Time frame: After 1 week dietary salt manipulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 23054827Krug AW, Tille E, Sun B, Pojoga L, Williams J, Chamarthi B, Lichtman AH, Hopkins PN, Adler GK, Williams GH. Lysine-specific demethylase-1 modifies the age effect on blood pressure sensitivity to dietary salt intake. Age (Dordr). 2013 Oct;35(5):1809-20. doi: 10.1007/s11357-012-9480-0. Epub 2012 Oct 2.
- Background: PubMed 22534796Williams JS, Chamarthi B, Goodarzi MO, Pojoga LH, Sun B, Garza AE, Raby BA, Adler GK, Hopkins PN, Brown NJ, Jeunemaitre X, Ferri C, Fang R, Leonor T, Cui J, Guo X, Taylor KD, Ida Chen YD, Xiang A, Raffel LJ, Buchanan TA, Rotter JI, Williams GH, Shi Y. Lysine-specific demethylase 1: an epigenetic regulator of salt-sensitive hypertension. Am J Hypertens. 2012 Jul;25(7):812-7. doi: 10.1038/ajh.2012.43. Epub 2012 Apr 26.
- Background: PubMed 21873498Pojoga LH, Williams JS, Yao TM, Kumar A, Raffetto JD, do Nascimento GR, Reslan OM, Adler GK, Williams GH, Shi Y, Khalil RA. Histone demethylase LSD1 deficiency during high-salt diet is associated with enhanced vascular contraction, altered NO-cGMP relaxation pathway, and hypertension. Am J Physiol Heart Circ Physiol. 2011 Nov;301(5):H1862-71. doi: 10.1152/ajpheart.00513.2011. Epub 2011 Aug 26.
- Derived from this study: PubMed 38437868Heydarpour M, Parksook WW, Pojoga LH, Williams GH, Williams JS. Mineralocorticoid Receptor and Aldosterone: Interaction Between NR3C2 Genetic Variants, Sex, and Age in a Mixed Cohort. J Clin Endocrinol Metab. 2024 Dec 18;110(1):e140-e149. doi: 10.1210/clinem/dgae127.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aldosterone response to AngII LS, Renal blood flow response to salt and Vascular Stiffness in people with Healthy Subjects, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aldosterone response to angiotensin II (time frame: After 1 week dietary salt manipulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029806, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.