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Protocol Details

Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study(GENE-FORECAST): Sodium Intervention Trial (SIT)/GENE-FORECAST SIT

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Human Genome Research Institute (NHGRI)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 21 Years
Max Age: 65 Years

Referral Letter Required


Population Exclusion(s)

Non-English Speaking;
Native Hawaiian/Pacific Islander;
American Indian or Alaskan Native


African American;
Cardiovascular Disease

Recruitment Keyword(s)



Cardiovascular Disease

Investigational Drug(s)


Investigational Device(s)



Other: placebo

Supporting Site

National Human Genome Research Institute


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.


To better understand the body s response to adding more salt to the diet.


U.S.-born African American adults ages 21 to 65 who are in good general health and took part in the GENE-FORECAST.


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.

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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.


-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.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Amadou Gaye, M.D.
National Human Genome Research Institute (NHGRI)
National Institutes of Health
Building 10
Room 7N316
10 Center Drive
Bethesda, Maryland 20892
(301) 402-1715

Nicole Plass-Hermitt, R.N.
National Human Genome Research Institute (NHGRI)
National Institutes of Health
Building 10
Room 7N317
10 Center Drive
Bethesda, Maryland 20892
(301) 451-3911

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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