Trial Outcomes & Findings for Visualizing Vascular Mechanisms of Salt Sensitivity (NCT NCT03696433)
NCT ID: NCT03696433
Last Updated: 2025-01-15
Results Overview
Mean arterial pressure following high-salt diet and low-salt diet
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Following completion of all dietary supplements and washout, in no less than 21 days.
Results posted on
2025-01-15
Participant Flow
Black men and women 18-55 years old with BMI 25 to \<35 kg/m2 with BP\< 140/90 mmHg at screening were recruited as long as they had not used medications for cardiovascular disease, a history of hypertension or diabetes, use of blood pressure or anti-diabetic medications, prevalent renal disease, abnormal serum sodium or potassium. As well as not being a current or prior smoker, pregnant, using hormone replacement therapy, oral contraceptives, or steroids, or had contraindications to MRI.
Participants went through a screening process with a physician to determine health and study qualifications. Once screening was complete, participants were assigned to either low-salt or high-salt diet study arm.
Participant milestones
| Measure |
Low- Then High-salt Diet
10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: low-salt diet, then washout consisting of the subject's typical diet, then high-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.
Low-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.
High-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.
|
High- Then Low-salt Diet
10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: high-salt diet, then washout consisting of the subject's typical diet, then low-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.
Low-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.
High-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tissue sodium content was not obtained in some participants in the low-then-high-salt diet group.
Baseline characteristics by cohort
| Measure |
Low- Then High-salt Diet
n=9 Participants
10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: low-salt diet, then washout consisting of the subject's typical diet, then high-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.
Low-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.
High-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.
|
High- Then Low-salt Diet
n=10 Participants
10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: high-salt diet, then washout consisting of the subject's typical diet, then low-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.
Low-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.
High-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Age, Continuous
|
25.4 years
n=9 Participants
|
28.1 years
n=10 Participants
|
26.8 years
n=19 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=19 Participants
|
|
Tissue Sodium Content of the Leg
|
14.84 mmol/L
STANDARD_DEVIATION 1.50 • n=6 Participants • Tissue sodium content was not obtained in some participants in the low-then-high-salt diet group.
|
14.33 mmol/L
STANDARD_DEVIATION 3.06 • n=10 Participants • Tissue sodium content was not obtained in some participants in the low-then-high-salt diet group.
|
14.60 mmol/L
STANDARD_DEVIATION 2.61 • n=16 Participants • Tissue sodium content was not obtained in some participants in the low-then-high-salt diet group.
|
PRIMARY outcome
Timeframe: Following completion of all dietary supplements and washout, in no less than 21 days.Population: All Subjects received both a low salt diet and high salt diet. Data reported reflects measure of mean arterial blood pressure following high-salt diet and low-salt diet.
Mean arterial pressure following high-salt diet and low-salt diet
Outcome measures
| Measure |
Low Salt Diet
n=19 Participants
Low-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.
|
High Salt Diet
n=19 Participants
High-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.
|
|---|---|---|
|
Mean Arterial Blood Pressure Following High-salt Diet and Low-salt Diet
|
83.3 mmHg
Standard Deviation 21.4
|
89.5 mmHg
Standard Deviation 9.55
|
Adverse Events
Low Salt Diet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Salt Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Salt Diet
n=19 participants at risk
Low-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.
|
High Salt Diet
n=19 participants at risk
High-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.
|
|---|---|---|
|
Metabolism and nutrition disorders
episode of syncope
|
5.3%
1/19 • Number of events 1 • Baseline up to 8 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/19 • Baseline up to 8 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
Additional Information
Cassandra Reynolds, BS, CCRC
Vanderbilt University Medical Center
Phone: 615-875-9854
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place