Trial Outcomes & Findings for Stress, Salt Excretion, and Nighttime Blood Pressure (NCT NCT03636490)

NCT ID: NCT03636490

Last Updated: 2025-05-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 323 participants
• Primary outcome timeframe: Over 24-hour ambulatory period
• Results posted on: 2025-05-11

Participant Flow

Participant milestones

Measure	Psychological Stress All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.
Overall Study STARTED	323
Overall Study COMPLETED	182
Overall Study NOT COMPLETED	141

Reasons for withdrawal

Measure

Psychological Stress All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

Overall Study Dropped out or incomplete data

141

Baseline Characteristics

Stress, Salt Excretion, and Nighttime Blood Pressure

Baseline characteristics by cohort

Measure	Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.
Age, Continuous	32.4 Years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex/Gender, Customized Female	113 Participants n=5 Participants
Sex/Gender, Customized Male	68 Participants n=5 Participants
Sex/Gender, Customized Prefers not to identify	1 Participants n=5 Participants
Sex/Gender, Customized Unknown	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	144 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	51 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants
Race (NIH/OMB) White	76 Participants n=5 Participants
Race (NIH/OMB) More than one race	25 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Current smoking Yes	5 Participants n=5 Participants
Current smoking No	177 Participants n=5 Participants
Alcohol use None	71 Participants n=5 Participants
Alcohol use Moderate	108 Participants n=5 Participants
Alcohol use Heavy	3 Participants n=5 Participants
Parental history of hypertension Yes	67 Participants n=5 Participants
Parental history of hypertension No	115 Participants n=5 Participants
Body mass index	24.3 kg/m2 STANDARD_DEVIATION 4.6 • n=5 Participants
Systolic blood pressure (baseline)	111.0 mm Hg STANDARD_DEVIATION 10.5 • n=5 Participants
Diastolic blood pressure (baseline)	72.2 mm Hg STANDARD_DEVIATION 6.9 • n=5 Participants
Glucose	89.1 mg/dL STANDARD_DEVIATION 7.1 • n=5 Participants

PRIMARY outcome

Timeframe: Over 24-hour ambulatory period

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1)

1.4 Ratio of awake-to-asleep Standard Deviation 1.3

PRIMARY outcome

Timeframe: Over 24-hour ambulatory period

Population: Of the 182 participants, 175 had complete data on ratio of awake-to-asleep urinary excretion rate and SBP dipping, and high-quality urine collection.

Systolic blood pressure (SBP) dipping refers to the normal physiological decline in SBP during nighttime sleep. SBP dipping (%) was calculated as 100 * (mean awake SBP - mean asleep SBP) / (mean awake SBP).

Outcome measures

Measure

Psychological Stress n=175 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

Systolic Blood Pressure Dipping (Aim 2)

14.3 percent Standard Deviation 6.0

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

This is to measure the ecological stress level for the awake period during which the participants' sodium excretion is monitored. A 10-point Visual Analog Scale (VAS) (0=Not at all, 5=Moderately, and 10=Extremely) was used to assess stress.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

Mean Perceived Stress Level

1.5 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

Rate of sodium excretion, measured from urine collected from participants during the ambulatory period.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

24-hour Sodium Excretion

121.8 mmol/24 hours Standard Deviation 51.4

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

Rate of potassium excretion, measured from urine collected from participants during the ambulatory period.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

24-hour Potassium Excretion

53.7 mmol/24 hours Standard Deviation 22.8

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

Rate of creatine clearance, measured from urine collected from participants during the ambulatory period.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

24-hour Creatinine Clearance

112.7 mL/min Standard Deviation 34.0

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

Fractional excretion of sodium is the amount of sodium that leaves the body through urine compared to the amount filtered and reabsorbed by the kidney.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

Fractional Excretion of Sodium

0.5 percent Standard Deviation 0.2

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported stress through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse stress. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

EMA Stress

1.5 Score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported anger through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse anger. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

EMA Anger

0.5 Score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported aggravation/irritation through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse aggravation. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

EMA Aggravation

0.8 Score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported anxiety through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse anxiety. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

EMA Anxiety

1.2 Score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Over 24-hour ambulatory period

10-point Ecological Momentary Assessment (EMA) measures self-reported sadness/depression through a questionnaire (0=Not at all, 5=Moderately, and 10=Extremely). Higher score indicates worse depression. The average EMA score over 5 time points in a 24-hour ambulatory period are reported.

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

EMA Depressed

0.6 Score on a scale Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Over 24-hour ambulatory period

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

Change in Urinary Sodium Excretion Rate With Stress

116.4 uEq/min Standard Deviation 125.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Over 24-hour ambulatory period

Systolic blood pressure (SBP) dipping refers to the normal physiological decline in SBP during nighttime sleep. SBP dipping (%) was calculated as 100 * (mean awake SBP - mean asleep SBP) / (mean awake SBP).

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

Systolic Blood Pressure Dipping

13.9 percent Standard Deviation 6.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Over 24-hour ambulatory period

Diastolic blood pressure (DBP) dipping refers to the normal physiological decline in DBP during nighttime sleep. DBP dipping (%) was calculated as 100 * (mean awake DBP - mean asleep DBP) / (mean awake DBP).

Outcome measures

Measure

Psychological Stress n=182 Participants All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks. Then during the ambulatory period, the participants underwent 24-hour ambulatory blood pressure monitoring during which urine was collected during the awake and asleep periods. Further, 5 ecological momentary assessment (EMA) ratings of perceived stress and negative affect (angry/hostile, aggravated/irritated, anxious/tense/nervous, and sad/blue/depressed) were collected during the awake period.

Diastolic Blood Pressure Dipping

19.9 percent Standard Deviation 7.9

Adverse Events

Psychological Stress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daichi Shimbo

Columbia University Irving Medical Center

Phone: ‭(646) 317-0305‬

Email: ds2231@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place