Cardiovascular DiseaseNCT04717336
Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENE-FORECAST): Sodium Intervention Trial (SIT)
A study testing Sodium Chloride in people with Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: Hypertension is a risk factor for heart disease. Low-sodium diets rich in fruits, vegetables, and other healthy foods are a good way to reduce blood pressure in people with hypertension. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Sodium Chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 8 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American men and women who are former GENE-FORECAST participants between 21 and 65 years of age. This criterion is inclusive of self-identified AA of both Hispanic, Latino and non-Hispanic, Latino ethnicities. Normotensive participants with systolic blood pressure (SBP) <140 mm Hg and diastolic blood pressure (DBP) <90 mm Hg and the absence of a history of prior diagnosis of hypertension.
- -Willingness and ability to participate in study procedures.
Who cannot join
- Individuals who are pregnant or breast-feeding.
- Individuals with high blood pressure or a history of hypertension.
- Individuals with a history of myocardial infarction, stroke, heart failure, diabetes, chronic liver or kidney diseases.
- Individuals who are taking antihypertensive, antidepressants, antidiabetic and antibiotic medications.
- Individuals currently participating in another NIH protocol.
- Individuals unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study(GENE-FORECAST): Sodium Intervention Trial (SIT)/GENE-FORECAST SIT
Background:
Hypertension is a risk factor for heart disease. Low-sodium diets rich in fruits, vegetables, and other healthy foods are a good way to reduce blood pressure in people with hypertension. Researchers want to learn more about why African Americans seem to have the greatest benefit from certain dietary interventions.
Read more
Objective:
To better understand the body's response to adding more salt to the diet.
Eligibility:
U.S.-born African American adults ages 21 to 65 who are in good general health and took part in the GENE-FORECAST.
Design:
Participants will be screened with a medical history and physical exam. If needed, they will take a pregnancy test. These tests will be repeated during the study.
Each day for 2 weeks, participants will take 3 capsules that contain either placebo or salt. Then they will take no pills for 3 weeks. Then they will take placebo or salt capsules for 2 more weeks.
Participants will talk about the foods and drinks they have consumed over the past 24 hours. They will take a survey about their physical activity and sleep.
Participants will complete taste tasks to obtain their responses to sweetness or saltiness. Sucrose and salt detection thresholds and preferences will be assessed.
Participants will give blood and urine samples. Saliva samples will be collected from their mouth by passive drool or by spitting into a sterile tube. Skin samples will be collected from behind their ears and the inner part of their elbow, using sterile swabs. Participants will get kits to collect stool samples at home.
Participants will have 4 study visits over 7 weeks.
Read the detailed description
The objective of this study is to implement a sodium intervention investigation to assess the effect of increased dietary sodium intake on changes in blood pressure, vascular function, microbiome, whole blood epigenome, whole blood and urine transcriptome as outcome measures. The study design will include a double-blind, cross-over treatment/placebo trial among African Americans GENE-FORECAST participants with normal blood pressure and will last 7 weeks. It is hypothesized that exposure to increased dietary sodium will affect blood pressure, whole blood epigenome, whole blood and urine transcriptome, vascular function, microbiome and blood pressure.
- Conditions
- Cardiovascular Disease
- Being tested
- Sodium Chloride, Placebo
- Keywords
- African American, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ChlorideOther
Also called salt treatment
It is well established that increased dietary sodium can predispose to an increase in blood pressure; particularly in salt-sensitive individuals. Seeking to test the hypothesis that changes in dietary sodium intake are sufficient to influence the composition of the gut microbiome in association with sodium-induced changes in vascular function, epigenome, transcriptome and blood pressure in African Americans.
PlaceboOther
placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Sodium Chloride then Placebo | Experimental | Participant will take Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Placebo at 3 pills per day for a total of 3 grams for two weeks. Receives: Other: Sodium Chloride; Other: Placebo |
| Cohort 2: Placebo then Sodium Chloride | Experimental | Participant will take Placebo at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks. Receives: Other: Sodium Chloride; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Vascular Function Measured by Pulse Wave Velocity
Mean change in vascular function was measured by Pulse Wave Velocity (PWV) using the SphygmoCor XCEL. PWV was determined by recording the pulse waves of the carotid and femoral arteries and calculating the ratio of the distance between the pulse measuring sites to the time delay between the carotid and femoral pulse waves. The distance was measured with a non-stretchable tape from the suprasternal notch to the carotid site and from the suprasternal notch to the femoral site. The former distance was subtracted from the latter and used in the calculation of PWV. High PWV is directly associated with increased arterial stiffness, reflecting reduced elasticity of the arterial walls.
Measured: Baseline, Week 2, Week 5 and Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start22 Jan 2021
- Primary completion30 Jun 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Amadou Gaye, PhD, Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717336
- Sponsor's protocol ID
- 10000070
- Other IDs
- 000070-H
- Status last verified
- 23 Jul 2024
- First submitted
- 20 Jan 2021
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study(GENE-FORECAST): Sodium Intervention Trial (SIT)/GENE-FORECAST SIT
- ClinicalTrials.gov ID
- NCT04717336
- Acronym / sponsor ID
- 10000070
- Conditions
- Cardiovascular Disease
- Keywords
- African American, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 27 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Hypertension is a risk factor for heart disease. Low-sodium diets rich in fruits, vegetables, and other healthy foods are a good way to reduce blood pressure in people with hypertension. Researchers want to learn more about why African Americans seem to have the greatest benefit from certain dietary interventions.
Objective:
To better understand the body's response to adding more salt to the diet.
Eligibility:
U.S.-born African American adults ages 21 to 65 who are in good general health and took part in the GENE-FORECAST.
Design:
Participants will be screened with a medical history and physical exam. If needed, they will take a pregnancy test. These tests will be repeated during the study.
Each day for 2 weeks, participants will take 3 capsules that contain either placebo or salt. Then they will take no pills for 3 weeks. Then they will take placebo or salt capsules for 2 more weeks.
Participants will talk about the foods and drinks they have consumed over the past 24 hours. They will take a survey about their physical activity and sleep.
Participants will complete taste tasks to obtain their responses to sweetness or saltiness. Sucrose and salt detection thresholds and preferences will be assessed.
Participants will give blood and urine samples. Saliva samples will be collected from their mouth by passive drool or by spitting into a sterile tube. Skin samples will be collected from behind their ears and the inner part of their elbow, using sterile swabs. Participants will get kits to collect stool samples at home.
Participants will have 4 study visits over 7 weeks.
Detailed description
The objective of this study is to implement a sodium intervention investigation to assess the effect of increased dietary sodium intake on changes in blood pressure, vascular function, microbiome, whole blood epigenome, whole blood and urine transcriptome as outcome measures. The study design will include a double-blind, cross-over treatment/placebo trial among African Americans GENE-FORECAST participants with normal blood pressure and will last 7 weeks. It is hypothesized that exposure to increased dietary sodium will affect blood pressure, whole blood epigenome, whole blood and urine transcriptome, vascular function, microbiome and blood pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Sodium Chloride then Placebo | Experimental | Other: Sodium Chloride, Other: PlaceboParticipant will take Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Placebo at 3 pills per day for a total of 3 grams for two weeks. |
| Cohort 2: Placebo then Sodium Chloride | Experimental | Other: Sodium Chloride, Other: PlaceboParticipant will take Placebo at 3 pills per day for a total of 3 grams for two weeks, followed by a wash-out period for three-weeks, then ending with a cross-over to the Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- African American men and women who are former GENE-FORECAST participants between 21 and 65 years of age. This criterion is inclusive of self-identified AA of both Hispanic, Latino and non-Hispanic, Latino ethnicities. Normotensive participants with systolic blood pressure (SBP) <140 mm Hg and diastolic blood pressure (DBP) <90 mm Hg and the absence of a history of prior diagnosis of hypertension.
- -Willingness and ability to participate in study procedures.
Key exclusion criteria (6 listed)
- Individuals who are pregnant or breast-feeding.
- Individuals with high blood pressure or a history of hypertension.
- Individuals with a history of myocardial infarction, stroke, heart failure, diabetes, chronic liver or kidney diseases.
- Individuals who are taking antihypertensive, antidepressants, antidiabetic and antibiotic medications.
- Individuals currently participating in another NIH protocol.
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 |
|---|---|---|
| Sodium ChlorideAlso: salt treatmentIt is well established that increased dietary sodium can predispose to an increase in blood pressure; particularly in salt-sensitive individuals. Seeking to test the hypothesis that changes in dietary sodium intake are sufficient to influence the composition of the gut microbiome in association with sodium-induced changes in vascular function, epigenome, transcriptome and blood pressure in African Americans. | Other | Cohort 1: Sodium Chloride then Placebo, Cohort 2: Placebo then Sodium Chloride |
| Placeboplacebo capsules | Other | Cohort 1: Sodium Chloride then Placebo, Cohort 2: Placebo then Sodium Chloride |
Primary outcome
Mean Change in Vascular Function Measured by Pulse Wave Velocity
Time frame: Baseline, Week 2, Week 5 and Week 7
Mean change in vascular function was measured by Pulse Wave Velocity (PWV) using the SphygmoCor XCEL. PWV was determined by recording the pulse waves of the carotid and femoral arteries and calculating the ratio of the distance between the pulse measuring sites to the time delay between the carotid and femoral pulse waves. The distance was measured with a non-stretchable tape from the suprasternal notch to the carotid site and from the suprasternal notch to the femoral site. The former distance was subtracted from the latter and used in the calculation of PWV. High PWV is directly associated with increased arterial stiffness, reflecting reduced elasticity of the arterial walls.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Amadou Gaye, PhD principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Chloride in people with Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 27 Apr 2025. 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. 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?
Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Vascular Function Measured by Pulse Wave Velocity (time frame: Baseline, Week 2, Week 5 and Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.