Trial Outcomes & Findings for Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese African Americans (NCT NCT04021355)
NCT ID: NCT04021355
Last Updated: 2026-08-20
Results Overview
Systolic blood pressure measured during sleep by 24-hour ambulatory blood pressure monitor starting on the 8th day of consuming the standarized diet plus chicken-based broth
COMPLETED
NA
61 participants
On the 8th day of consuming the standarized diet plus chicken-based broth
2026-08-20
Participant Flow
A total of 68 participants were screened for eligibilty in the study between November 2020 to April 2025.
A total of 7 participants who were screened decided not to participate before randomization because of inability to adhere to time requirements of the study or the study diets. This left 61 participants who were enrolled in the study.
Participant milestones
| Measure |
Morning Sodium Intervention, Then Evening Sodium Intervention
The study was conducted as a randomized, crossover feeding trial. During the first seven days of this period (run-in period), participants consumed only the study meals to standardize sodium intake. During the final nine days of this period (intervention period), participants continued to eat study meals and additionally consumed a chicken-based broth containing a total of 2 grams of sodium with breakfast (morning sodium). After a 4-week washout period, participants crossed over to the second study arm in which they consumed the study meals for seven days, and then consumed the study meals + a chicken-based broth containing a total of 2 grams of sodium with dinner for nine days (evening sodium).
|
Evening Sodium Intervention, Followed by Morning Sodium Intervention
The study was conducted as a randomized, crossover feeding trial. During the first seven days of this period (run-in period), participants consumed only the study meals to standardize sodium intake. During the final nine days of this period (intervention period), participants continued to eat study meals and additionally consumed a chicken-based broth containing a total of 2 grams of sodium with dinner (evening sodium). After a 4-week washout period, participants crossed over to the second study arm in which they consumed the study meals for seven days, and then consumed the study meals + a chicken-based broth containing a total of 2 grams of sodium with breakfast for nine days (morning sodium).
|
|---|---|---|
|
Second Intervention (16 days)
NOT COMPLETED
|
0
|
0
|
|
First Intervention (16 days)
STARTED
|
35
|
26
|
|
First Intervention (16 days)
COMPLETED
|
30
|
23
|
|
First Intervention (16 days)
NOT COMPLETED
|
5
|
3
|
|
Washout (4 weeks)
STARTED
|
30
|
23
|
|
Washout (4 weeks)
COMPLETED
|
27
|
21
|
|
Washout (4 weeks)
NOT COMPLETED
|
3
|
2
|
|
Second Intervention (16 days)
STARTED
|
27
|
21
|
|
Second Intervention (16 days)
COMPLETED
|
27
|
21
|
Reasons for withdrawal
| Measure |
Morning Sodium Intervention, Then Evening Sodium Intervention
The study was conducted as a randomized, crossover feeding trial. During the first seven days of this period (run-in period), participants consumed only the study meals to standardize sodium intake. During the final nine days of this period (intervention period), participants continued to eat study meals and additionally consumed a chicken-based broth containing a total of 2 grams of sodium with breakfast (morning sodium). After a 4-week washout period, participants crossed over to the second study arm in which they consumed the study meals for seven days, and then consumed the study meals + a chicken-based broth containing a total of 2 grams of sodium with dinner for nine days (evening sodium).
|
Evening Sodium Intervention, Followed by Morning Sodium Intervention
The study was conducted as a randomized, crossover feeding trial. During the first seven days of this period (run-in period), participants consumed only the study meals to standardize sodium intake. During the final nine days of this period (intervention period), participants continued to eat study meals and additionally consumed a chicken-based broth containing a total of 2 grams of sodium with dinner (evening sodium). After a 4-week washout period, participants crossed over to the second study arm in which they consumed the study meals for seven days, and then consumed the study meals + a chicken-based broth containing a total of 2 grams of sodium with breakfast for nine days (morning sodium).
|
|---|---|---|
|
First Intervention (16 days)
Withdrawal by Subject
|
5
|
3
|
|
Washout (4 weeks)
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese African Americans
Baseline characteristics by cohort
| Measure |
Morning Sodium Intervention, Then Evening Sodium Intervention
n=35 Participants
Participants consumed only the study meals during the first seven days of the intervention, followed by eating study meals and a chicken-based broth containing a total of 2 grams of sodium with breakfast for the final nine days of the first intervention period (morning sodium). After a 4-week washout period, participants crossed over to the second intervention period in which they consumed the study meals for seven days, and then consumed the study meals plus broth containing a total of 2 grams of sodium with dinner for nine days (evening sodium).
|
Evening Sodium Intervention, Then Morning Sodium Intervention
n=26 Participants
Participants consumed only the study meals during the first seven days of the intervention, followed by eating study meals and a chicken-based broth containing a total of 2 grams of sodium with dinner for the final nine days of the first intervention period (evening sodium). After a 4-week washout period, participants crossed over to the second intervention period in which they consumed the study meals for seven days, and then consumed the study meals plus broth containing a total of 2 grams of sodium with breakfast for nine days (morning sodium).
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 Years
STANDARD_DEVIATION 6 • n=5 Participants
|
37 Years
STANDARD_DEVIATION 5 • n=109 Participants
|
36 Years
STANDARD_DEVIATION 6 • n=133 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
20 Participants
n=109 Participants
|
46 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=109 Participants
|
15 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
19 Participants
n=109 Participants
|
42 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
7 Participants
n=109 Participants
|
19 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: On the 8th day of consuming the standarized diet plus chicken-based brothPopulation: A total of 8 participants withdrew from the study before primary outcome measures were able to be collected
Systolic blood pressure measured during sleep by 24-hour ambulatory blood pressure monitor starting on the 8th day of consuming the standarized diet plus chicken-based broth
Outcome measures
| Measure |
Morning Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with breakfast each day.
|
Evening Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with dinner each day.
|
|---|---|---|
|
Sleep Systolic Blood Pressure
|
122.7 mmHg
Interval 117.3 to 128.1
|
118.9 mmHg
Interval 113.4 to 124.5
|
SECONDARY outcome
Timeframe: On the 9th day of consuming the standarized diet plus chicken-based brothPopulation: A total of 8 participants withdrew from the study before outcome measures could be collected
Urinary sodium excretion measured in study arms by 24-hour urine collection starting on the 9th day of consuming the standarized diet plus chicken-based broth
Outcome measures
| Measure |
Morning Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with breakfast each day.
|
Evening Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with dinner each day.
|
|---|---|---|
|
24-hour Urinary Sodium Excretion
|
213.2 mmoL
Standard Deviation 76.1
|
199.3 mmoL
Standard Deviation 76
|
SECONDARY outcome
Timeframe: On the 9th day of consuming the standarized diet plus chicken-based brothPopulation: A total of 8 participants withdrew from the study before primary outcome measures were able to be collected
Plasma melatonin concentrations measured in blood samples collected every 2 hours for 24 hours starting on the 9th day of consuming the standarized diet plus chicken-based broth
Outcome measures
| Measure |
Morning Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with breakfast each day.
|
Evening Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with dinner each day.
|
|---|---|---|
|
Concentrations of Plasma Melatonin
|
5 pg/ml
Interval 2.0 to 16.0
|
5 pg/ml
Interval 2.0 to 17.0
|
SECONDARY outcome
Timeframe: On the 9th day of consuming the standarized diet plus chicken-based brothPopulation: A total of 8 participants withdrew from the study before primary outcome measures were able to be collected
Plasma cortisol concentrations measured in study participants every 2 hours for 24 hours starting on the 9th day of consuming the standarized diet plus chicken-based broth
Outcome measures
| Measure |
Morning Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with breakfast each day.
|
Evening Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with dinner each day.
|
|---|---|---|
|
Concentrations of Plasma Cortisol
|
3.2 ug/dL
Interval 2.6 to 4.1
|
3.6 ug/dL
Interval 2.8 to 4.4
|
SECONDARY outcome
Timeframe: On the 9th day of consuming the standarized diet plus chicken-based brothPopulation: A total of 8 participants withdrew from the study before primary outcome measures were able to be collected
Plasma endothelin 1 concentrations measured every 2 hours for 24 hours starting on the 9th day of consuming the standarized diet plus chicken-based broth
Outcome measures
| Measure |
Morning Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with breakfast each day.
|
Evening Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with dinner each day.
|
|---|---|---|
|
Concentrations of Plasma Endothelin 1
|
1.4 pg/ml
Interval 0.6 to 1.8
|
1.2 pg/ml
Interval 0.8 to 1.8
|
SECONDARY outcome
Timeframe: On the 9th day of consuming the standarized diet plus chicken-based brothPopulation: A total of 8 participants withdrew from the study prior to collection of study outcome data.
Plasma aldosterone concentrations measured every 2 hours for 24 hours starting on the 9th day of consuming the standarized diet plus chicken-based broth
Outcome measures
| Measure |
Morning Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with breakfast each day.
|
Evening Sodium
n=53 Participants
Participants consumed a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they consumed the same standardized diet for 9 days and in addition received 2 g of sodium in the form of a chicken-based broth with dinner each day.
|
|---|---|---|
|
Concentrations of Plasma Aldosterone
|
101 ng/dL
Interval 62.0 to 201.0
|
103 ng/dL
Interval 66.0 to 223.0
|
SECONDARY outcome
Timeframe: On the 8th day of consuming the standardized diet plus chicken-based brothCore Body Temperature measured using BodyCap On the 8th day of consuming the standardized diet plus chicken-based broth
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On the 9th day of consuming the standardized diet plus chicken-based brothTiming of melatonin increase based on every 2-hour blood draws during the 24 hour admission on the 9th day of consuming the standardized diet plus chicken-based broth
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On the 9th day of consuming the standarized diet plus chicken-based brothTiming of clock gene expression change based on every 2-hour blood draws during the 24 hour admission on the 9th day of consuming the standardized diet plus chicken-based broth
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On the 9th day of consuming the standarized diet plus chicken-based brothChanges in plasma cytokines based on every 2-hour blood draws during the 24 hour admission on the 9th day of consuming the standardized diet plus chicken-based broth
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On the 9th day of consuming the standarized diet plus chicken-based brothChange in circulating immune cell proportions based on every 2-hour blood draws during the 24 hour admission on the 9th day of consuming the standardized diet plus chicken-based broth
Outcome measures
Outcome data not reported
Adverse Events
Morning Sodium
Evening Sodium
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place