Trial Outcomes & Findings for CARDIA-Salt Sensitivity of Blood Pressure (SSBP) (NCT NCT04258332)
NCT ID: NCT04258332
Last Updated: 2026-07-07
Results Overview
The change in 24-hour ambulatory mean arterial pressure (MAP) following one week of high-salt and following one week of low-salt diet. This is calculated as the 24 hour ambulatory MAP on the high-salt diet minus the 24 hour ambulatory MAP on the low-salt diet.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
281 participants
Primary outcome timeframe
14 days total which is 7 days each of high- and low-salt diet
Results posted on
2026-07-07
Participant Flow
A total of 281 individuals consented (were enrolled). Of these 228 actually started the study, i.e., were assigned to a study group. The 53 that were consented/enrolled but did not start the study, either did not schedule study start dates, or no longer wanted to participate prior to assignment of study diet order. This study investigates salt-sensitivity of BP (SSBP), measured as change in BP between one-week of high-salt minus one-week of low-salt diet. SSBP was determined in 213.
Participant milestones
| Measure |
High Salt Diet Then Low Salt Diet
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
Low Salt Diet Then High Salt Diet
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
|
Overall Study
STARTED
|
124
|
104
|
|
Overall Study
COMPLETED
|
118
|
95
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CARDIA-Salt Sensitivity of Blood Pressure (SSBP)
Baseline characteristics by cohort
| Measure |
High Salt Diet Then Low Salt Diet
n=118 Participants
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
Low Salt Diet Then High Salt Diet
n=95 Participants
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=20 Participants
|
61 years
n=20 Participants
|
61 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=20 Participants
|
63 Participants
n=20 Participants
|
139 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
74 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
136 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=20 Participants
|
31 Participants
n=20 Participants
|
70 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
118 participants
n=20 Participants
|
95 participants
n=20 Participants
|
213 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 14 days total which is 7 days each of high- and low-salt dietPopulation: Participants were randomized to one of two arms: either a high salt diet first, then low salt diet, or low salt diet first then low salt diet. The goal of the study was to quantify the within individual change in mean arterial pressure between high- and low-sodium diet. Therefore, arms are presented according to randomized diet order rather than overall high- or low-sodium diet at any point. In total it took 14 days to complete the high- and low-sodium diets that lasted for one-week each.
The change in 24-hour ambulatory mean arterial pressure (MAP) following one week of high-salt and following one week of low-salt diet. This is calculated as the 24 hour ambulatory MAP on the high-salt diet minus the 24 hour ambulatory MAP on the low-salt diet.
Outcome measures
| Measure |
High Salt Diet Then Low Salt Diet
n=118 Participants
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
Low Salt Diet Then High Salt Diet
n=95 Participants
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
|---|---|---|
|
Salt Sensitivity of Blood Pressure
|
4.0 mm Hg
Interval 0.3 to 7.0
|
3.2 mm Hg
Interval -1.2 to 8.8
|
PRIMARY outcome
Timeframe: 14 days total which is 7 days each of high- and low-salt dietPopulation: Participants were randomized to one of two arms: either a high salt diet first, then low salt diet, or low salt diet first then low salt diet. The goal of this aim was to quantify the within individual change in interleukin-6 between high- and low-sodium diet. Therefore, arms are presented according to randomized diet order rather than overall high- or low-sodium diet at any point. In total it took 14 days to complete the high- and low-sodium diets that lasted for one-week each.
The change in circulating levels of interleukin-6 (IL-6) following one week of high-salt and following one week of low-salt diet. This is calculated as the IL-6 level on the high-salt diet minus the IL-6 level on the low-salt diet.
Outcome measures
| Measure |
High Salt Diet Then Low Salt Diet
n=106 Participants
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
Low Salt Diet Then High Salt Diet
n=85 Participants
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
|---|---|---|
|
Immune Response to Dietary Salt Loading, Change in Circulating Levels of IL-6
|
-0.004 pg/ml
Interval -0.55 to 0.586
|
-0.015 pg/ml
Interval -0.521 to 0.439
|
PRIMARY outcome
Timeframe: 14 days total which is 7 days each of high- and low-salt dietPopulation: Participants were randomized to one of two arms: either a high salt diet first, then low salt diet, or low salt diet first then low salt diet. The goal of this aim was to quantify the within individual change in interleukin-17 between high- and low-sodium diet. Therefore, arms are presented according to randomized diet order rather than overall high- or low-sodium diet at any point. In total it took 14 days to complete the high- and low-sodium diets that lasted for one-week each.
The change in circulating levels of interleukin-17 (IL-17) following one week of high-salt and following one week of low-salt diet. This is calculated as the IL-17 level on the high-salt diet minus the IL-17 level on the low-salt diet.
Outcome measures
| Measure |
High Salt Diet Then Low Salt Diet
n=106 Participants
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
Low Salt Diet Then High Salt Diet
n=84 Participants
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
|---|---|---|
|
Immune Response to Dietary Salt Loading, Change in Circulating Levels of IL-17
|
0 pg/ml
Interval -0.98 to 1.05
|
0 pg/ml
Interval -1.21 to 1.07
|
PRIMARY outcome
Timeframe: 14 days total which is 7 days each of high- and low-salt dietPopulation: Participants were randomized to one of two arms: either a high salt diet first, then low salt diet, or low salt diet first then low salt diet. The goal of this aim was to quantify the within individual change in interleukin-10 between high- and low-sodium diet. Therefore, arms are presented according to randomized diet order rather than overall high- or low-sodium diet at any point. In total it took 14 days to complete the high- and low-sodium diets that lasted for one-week each.
The change in circulating levels of interleukin-10 (IL-10) following one week of high-salt and following one week of low-salt diet. This is calculated as the IL-10 level on the high-salt diet minus the IL-10 level on the low-salt diet.
Outcome measures
| Measure |
High Salt Diet Then Low Salt Diet
n=106 Participants
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
Low Salt Diet Then High Salt Diet
n=84 Participants
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
High Salt Diet: Patients will be randomized to be on a high salt diet for 7 days.
Low Salt Diet: Patients will be randomized to be on a low salt for 7 days.
|
|---|---|---|
|
Immune Response to Dietary Salt Loading, IL-10, Change in Circulating Levels of IL-10
|
-0.17 pg/ml
Interval -0.72 to 0.74
|
0.05 pg/ml
Interval -0.58 to 0.62
|
Adverse Events
High Salt Diet
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Low Salt Diet
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Salt Diet
n=217 participants at risk
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake. In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
Adverse events were ascertained in relation to any exposure to high-salt diet regardless of diet-sequence or completion of both high- and low-salt diets.
|
Low Salt Diet
n=215 participants at risk
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
Adverse events were ascertained in relation to any exposure to low-salt diet regardless of diet-sequence or completion of both high- and low-salt diets.
|
|---|---|---|
|
General disorders
Headache
|
2.8%
6/217 • Number of events 6 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
1.4%
3/215 • Number of events 3 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
Gastrointestinal disorders
GI Upset
|
2.8%
6/217 • Number of events 6 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
1.4%
3/215 • Number of events 3 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
Musculoskeletal and connective tissue disorders
Cramp
|
0.46%
1/217 • Number of events 1 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
2.3%
5/215 • Number of events 5 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
General disorders
Edema
|
2.8%
6/217 • Number of events 6 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
0.00%
0/215 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
General disorders
Oral symptoms
|
0.92%
2/217 • Number of events 3 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
0.47%
1/215 • Number of events 2 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
General disorders
Lightheaded
|
2.3%
5/217 • Number of events 5 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
2.3%
5/215 • Number of events 6 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
General disorders
Pain
|
0.92%
2/217 • Number of events 2 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
0.00%
0/215 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
General disorders
Dyspnea
|
0.46%
1/217 • Number of events 1 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
0.00%
0/215 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/217 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
0.47%
1/215 • Number of events 1 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/217 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
0.47%
1/215 • Number of events 1 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/217 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
0.47%
1/215 • Number of events 1 • 7 days during high-salt diet week and 7 days during low-salt diet week
At the end of the high- or low-salt diet, participants self-reported symptoms or events. If one diet week was completed, but not the other, adverse events were still ascertained during the completed diet week. Thus, adverse events were ascertained in relation to diet, which differs from the outcome measures of changes from high- to low-salt diet. For adverse events, the number at risk is based on an "as treated" analysis, i.e., those exposed to either study diet.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place