Aging, Hypertension, Physical Disability
Conditions
Keywords
Sodium Intake, Blood Pressure, Hypertension, Physical Function, Older Adults, Randomized Controlled Trial
Brief summary
This study will examine the effects of low sodium meal plan on seated blood pressure in older adults from a community-based, congregate senior living facility.
Detailed description
Hypertension in older adults is a known contributor to both cardiovascular disease and falls. The Centers of Disease Control advocates for low sodium, senior meal plans as a strategy to lower blood pressure (BP). However, sodium is recommended to treat orthostatic hypotension (OH), a risk factor of falls. The long-term effects of low sodium intake on physical function are largely unknown in older adults. The objective of this proposed pilot study is to determine the feasibility of an individual-level, randomized feeding study that examines the impact of sodium reduction on BP regulation among 40 semi-independent, older adults aged 60 and above. Primary Aim 1: To determine the effects of a low sodium (\<0.9 mg per kcal of energy intake), 2-week meal plan compared with a usual meal plan (average sodium \ 2 mg per kcal of energy intake) on seated BP among independently living older adults. Hypothesis Aim 1: Compared with the usual meal plan, a reduced sodium meal plan will lower seated BP in older adults after 2 weeks. Feasibility Aim 1: To evaluate the recruitment experience, meal cost, meal delivery logistics, and compliance with and tolerability of the meal plan (urine sodium and palatability questionnaires). Feasibility Aim 2: To determine effect size (variance) of secondary outcomes: standing BP, OH (standing minus seated BP), orthostatic symptoms, and a timed up and go test (TUG). Eligible participants will be randomized to low versus usual sodium meal plans for two weeks. Assessments will be made at the in-person baseline visit, one week telephonic interview and 2 week in person follow-up visit. The primary outcome is seated BP and secondary outcomes include orthostatic hypertension and Timed Up and Go (TUG) tests. Both primary and secondary outcomes will be measured twice: (1) before the study begins (baseline), and (2) after 2 week period. Patient-reported outcomes, dietary compliance, and urine electrolytes will be assessed as well. Intent-to-treat analysis will be conducted for all endpoints.
Interventions
OTHERDietary intervention
Intervention include low sodium or usual sodium diet
Sponsors
Beth Israel Deaconess Medical Center
Hebrew SeniorLife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Study staff involved in administering the dietary intervention and assessing compliance will be masked to participants' outcome assessments (e.g. BP).
Intervention model description
Participants will be randomized to either a low sodium diet or a usual sodium diet for a period of two weeks.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Resident at Jack Satter House in Revere * Age \>= 60 years * Resting systolic blood pressure 100-149 mm Hg and diastolic blood pressure \<100 mm Hg * Stable BP medications (no recent or intended changes)
Exclusion criteria
* Cognitive Impairment (Montreal Cognitive Assessment test \<18) * Unstable blood pressure medications in the past 2 months * Terminal or mental illness * Severe allergies to common foods * Unwillingness to comply with the diet * Physical inability to do a timed up and go test * Active kidney dialysis or history of kidney transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seated Blood Pressure | 2 weeks | Average of three seated systolic and diastolic blood pressure readings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Orthostatic Hypotension | 2 weeks | Measured from supine and standing systolic and diastolic blood pressure readings |
Other
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go Test | 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. |
Countries
United States
Participant flow
Recruitment details
Of the approximately 285 residents of Jack Satter House, 59 adults expressed interest in participation. We ultimately enrolled 20 participants.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| 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 | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Usual Sodium Diet | Low Sodium Diet | Total |
|---|---|---|---|
| Age, Continuous | 79.6 years STANDARD_DEVIATION 9.4 | 76.9 years STANDARD_DEVIATION 6.1 | 78.1 years STANDARD_DEVIATION 7.7 |
| BMI, kg/m^2 | 31.9 kg/m^2 STANDARD_DEVIATION 7.9 | 32.3 kg/m^2 STANDARD_DEVIATION 7.2 | 32.1 kg/m^2 STANDARD_DEVIATION 7.3 |
| Diastolic blood pressure, mmHg | 62 mmHg STANDARD_DEVIATION 7.5 | 65.3 mmHg STANDARD_DEVIATION 11.1 | 63.9 mmHg STANDARD_DEVIATION 9.5 |
| Estimated calorie intake, kcal/d | 1785 kcal/day STANDARD_DEVIATION 311 | 1849 kcal/day STANDARD_DEVIATION 244 | 1820 kcal/day STANDARD_DEVIATION 270 |
| Hypertension, % | 5 Participants | 6 Participants | 11 Participants |
| Hypertension medication use, % | 5 Participants | 7 Participants | 12 Participants |
| Measured orthostatic hypertension, % | 2 Participants | 0 Participants | 2 Participants |
| Montreal Cognitive Assessment score | 23.6 scores on a scale STANDARD_DEVIATION 1.9 | 24.3 scores on a scale STANDARD_DEVIATION 3.3 | 23.9 scores on a scale STANDARD_DEVIATION 2.7 |
| Physical activity score | 22.8 scores on a scale STANDARD_DEVIATION 13.7 | 15.9 scores on a scale STANDARD_DEVIATION 15.1 | 19.0 scores on a scale STANDARD_DEVIATION 14.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
| Systolic blood pressure, mmHg | 121.1 mmHg STANDARD_DEVIATION 12.2 | 123.5 mmHg STANDARD_DEVIATION 9.7 | 122.5 mmHg STANDARD_DEVIATION 10.7 |
| Timed-up-and-go, sec | 13.4 seconds STANDARD_DEVIATION 3.9 | 14.0 seconds STANDARD_DEVIATION 6.2 | 13.7 seconds STANDARD_DEVIATION 5.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 0 / 11 | 2 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
Primary
Seated Blood Pressure
Average of three seated systolic and diastolic blood pressure readings
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Sodium Diet | Seated Blood Pressure | Follow-up seated systolic blood pressure | 112.1 mmHg | Standard Deviation 7.6 |
| Low Sodium Diet | Seated Blood Pressure | Follow-up seated diastolic blood pressure | 60.3 mmHg | Standard Deviation 9.6 |
| Usual Sodium Diet | Seated Blood Pressure | Follow-up seated systolic blood pressure | 116.1 mmHg | Standard Deviation 13 |
| Usual Sodium Diet | Seated Blood Pressure | Follow-up seated diastolic blood pressure | 60.4 mmHg | Standard Deviation 8 |
Secondary
Orthostatic Hypotension
Measured from supine and standing systolic and diastolic blood pressure readings
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Sodium Diet | Orthostatic Hypotension | 3 Participants |
| Usual Sodium Diet | Orthostatic Hypotension | 5 Participants |
Other Pre-specified
Timed up and go Test
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Sodium Diet | Timed up and go Test | 13.8 seconds | Standard Deviation 5.6 |
| Usual Sodium Diet | Timed up and go Test | 13.8 seconds | Standard Deviation 4.9 |