Blood Pressure Clinical Trial
Official title:
Genetic Epidemiology Network of Salt Sensitivity
High blood pressure is a serious health problem. In terms of diet recommendations, people with this condition are encouraged to eat a low sodium and high potassium diet. It is believed that genetics may play a role in the development of high blood pressure and may affect changes in blood pressure levels, including changes brought on by sodium and potassium. This study will identify genetic factors that may influence blood pressure changes due to increased salt or potassium intake in people with mildly elevated blood pressure and in their family members.
High blood pressure is one of the most common health problems among adults. If left
untreated, it can lead to heart failure, kidney failure, or stroke. Common causes include
stress, diet, diabetes, kidney disease, or obesity. Typical treatments include taking
medication, losing weight, and quitting smoking. It is also recommended that people with
high blood pressure or those at risk of developing high blood pressure modify their diets to
decrease sodium intake and increase potassium intake. Research has shown that genetics may
play a role in the development of high blood pressure and may affect fluctuations of blood
pressure levels, including blood pressure changes brought on by sodium and potassium. This
study will identify and analyze the genetic factors that may be responsible for blood
pressure changes due to dietary salt and potassium intake. Blood samples collected in this
study may also be used for future genetic research on blood pressure.
This study will enroll people who have mildly elevated blood pressure and their siblings,
spouses, and children. Participants will first take part in a 3-day observation period. At a
Day 1 study visit, participants' weight, height, waist size, and blood pressure will be
measured. There will be three separate blood pressure measurements. Study staff will then
interview participants to collect information on family and personal medical history,
cigarette smoking habits, alcohol consumption, physical activity, and diet. Finally, blood
samples will be collected. For 24 hours after the first study visit, participants will
collect their urine. At study visits on Days 2 and 3, participants will undergo three blood
pressure measurements and a cold pressor test, which measures blood pressure at different
body temperatures. Participants will also collect a urine sample each night.
After the 3-day observation period, participants will take part in a 3-week treatment
period. Each day, all participants will eat breakfast, lunch, and dinner in the study
kitchen. For Days 1 through 7, participants will eat a low sodium diet; for Days 7 through
14, participants will eat a high sodium diet; and for Days 14 through 21, participants will
eat a high sodium diet and receive potassium supplements. Blood pressure will be measured
three times per day and urine will be collected at several times during this period. Blood
samples will be collected at the end of each week.
Parents of participants will also be enrolled in this study, and they will complete the same
study procedures that participants complete during the 3-day observation period except for
the urine collection.
The study completion date listed in this record was obtained from the "Completed Date"
entered in the Query View Report System (QVR).
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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