Trial Outcomes & Findings for The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults (NCT NCT04074941)

NCT ID: NCT04074941

Last Updated: 2021-05-11

Results Overview

Average of three seated systolic and diastolic blood pressure readings

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2021-05-11

Participant Flow

Of the approximately 285 residents of Jack Satter House, 59 adults expressed interest in participation. We ultimately enrolled 20 participants.

Participant milestones

Measure	Low Sodium Diet This group will get a low sodium diet (\<0.9 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet	Usual Sodium Diet This group will get a usual sodium diet (\~2 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults

Baseline characteristics by cohort

Measure	Low Sodium Diet n=11 Participants This group will get a low sodium diet (\<0.9 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet	Usual Sodium Diet n=9 Participants This group will get a usual sodium diet (\~2 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet	Total n=20 Participants Total of all reporting groups
Age, Continuous	76.9 years STANDARD_DEVIATION 6.1 • n=5 Participants	79.6 years STANDARD_DEVIATION 9.4 • n=7 Participants	78.1 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Systolic blood pressure, mmHg	123.5 mmHg STANDARD_DEVIATION 9.7 • n=5 Participants	121.1 mmHg STANDARD_DEVIATION 12.2 • n=7 Participants	122.5 mmHg STANDARD_DEVIATION 10.7 • n=5 Participants
Diastolic blood pressure, mmHg	65.3 mmHg STANDARD_DEVIATION 11.1 • n=5 Participants	62 mmHg STANDARD_DEVIATION 7.5 • n=7 Participants	63.9 mmHg STANDARD_DEVIATION 9.5 • n=5 Participants
Hypertension, %	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Hypertension medication use, %	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Measured orthostatic hypertension, %	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
BMI, kg/m^2	32.3 kg/m^2 STANDARD_DEVIATION 7.2 • n=5 Participants	31.9 kg/m^2 STANDARD_DEVIATION 7.9 • n=7 Participants	32.1 kg/m^2 STANDARD_DEVIATION 7.3 • n=5 Participants
Montreal Cognitive Assessment score	24.3 scores on a scale STANDARD_DEVIATION 3.3 • n=5 Participants	23.6 scores on a scale STANDARD_DEVIATION 1.9 • n=7 Participants	23.9 scores on a scale STANDARD_DEVIATION 2.7 • n=5 Participants
Physical activity score	15.9 scores on a scale STANDARD_DEVIATION 15.1 • n=5 Participants	22.8 scores on a scale STANDARD_DEVIATION 13.7 • n=7 Participants	19.0 scores on a scale STANDARD_DEVIATION 14.5 • n=5 Participants
Timed-up-and-go, sec	14.0 seconds STANDARD_DEVIATION 6.2 • n=5 Participants	13.4 seconds STANDARD_DEVIATION 3.9 • n=7 Participants	13.7 seconds STANDARD_DEVIATION 5.1 • n=5 Participants
Estimated calorie intake, kcal/d	1849 kcal/day STANDARD_DEVIATION 244 • n=5 Participants	1785 kcal/day STANDARD_DEVIATION 311 • n=7 Participants	1820 kcal/day STANDARD_DEVIATION 270 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Average of three seated systolic and diastolic blood pressure readings

Outcome measures

Measure	Low Sodium Diet n=11 Participants This group will get a low sodium diet (\<0.9 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet	Usual Sodium Diet n=9 Participants This group will get a usual sodium diet (\~2 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet
Seated Blood Pressure Follow-up seated systolic blood pressure	112.1 mmHg Standard Deviation 7.6	116.1 mmHg Standard Deviation 13.0
Seated Blood Pressure Follow-up seated diastolic blood pressure	60.3 mmHg Standard Deviation 9.6	60.4 mmHg Standard Deviation 8.0

SECONDARY outcome

Timeframe: 2 weeks

Measured from supine and standing systolic and diastolic blood pressure readings

Outcome measures

Measure	Low Sodium Diet n=11 Participants This group will get a low sodium diet (\<0.9 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet	Usual Sodium Diet n=9 Participants This group will get a usual sodium diet (\~2 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet
Orthostatic Hypotension	3 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Participant will be asked to start from seated position, stand up from the chair, walk 3 meters in a straight line, turn, walk back to the chair and sit down. The investigators will use average of the two trials.

Outcome measures

Measure	Low Sodium Diet n=11 Participants This group will get a low sodium diet (\<0.9 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet	Usual Sodium Diet n=9 Participants This group will get a usual sodium diet (\~2 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet
Timed up and go Test	13.8 seconds Standard Deviation 5.6	13.8 seconds Standard Deviation 4.9

Adverse Events

Low Sodium Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Sodium Diet

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low Sodium Diet n=11 participants at risk This group will get a low sodium diet (\<0.9 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet	Usual Sodium Diet n=9 participants at risk This group will get a usual sodium diet (\~2 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet
Endocrine disorders High blood glucose in participants with baseline diabetes	0.00% 0/11 • 2 weeks	22.2% 2/9 • Number of events 2 • 2 weeks

Additional Information

Shivani Sahni, PhD

Marcus Institute, Hebrew SeniorLife

Phone: 6179715382

Email: shivanisahni@hsl.harvard.edu

Results disclosure agreements

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