Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 000070-H |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Human Genome Research Institute (NHGRI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Chloride | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 2, Week 5 and Week 7 |
Not provided
Not provided
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.
EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amadou Gaye, PhD | National Human Genome Research Institute (NHGRI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
Not provided
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Chloride Then Placebo | 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. |
| FG001 | Placebo Then Sodium Chloride |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Baseline to Week 2 |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Other | placebo capsules |
|
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout: Week 2 to Week 5 |
|
|
| Period 2: Week 5 to Week 7 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Chloride Then Placebo | 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. |
| BG001 | Placebo Then Sodium Chloride | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis includes only those participants that completed the Pulse Wave Velocity at every visit (n=23). | Posted | Mean | Standard Deviation | m/s | Baseline, Week 2, Week 5 and Week 7 |
|
|
|
|
7 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Chloride | Participant will take Sodium Chloride at 3 pills per day for a total of 3 grams for two weeks. | 0 | 32 | 0 | 32 | 1 | 32 |
| EG001 | Placebo | Participant will take Placebo at 3 pills per day for a total of 3 grams for two weeks. | 0 | 32 | 0 | 32 | 1 | 32 |
| EG002 | Wash-Out Period | Participants do not take any study intervention for this washout period. | 0 | 32 | 0 | 32 | 0 | 32 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hives | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Georg Aue, MD | The National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) | 301.451.7141 | aueg@nhlbi.nih.gov |
| Nov 27, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2021 | Nov 27, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Week 5 |
|
| Week 7 |
|