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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension, Physical Disability, Aging

Intervention / Treatment
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* Other: Dietary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to either a low sodium diet or a usual sodium diet for a period of two weeks.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low sodium diet<br>This group will get a low sodium diet (<0.9 mg per kcal of energy intake). | Other: Dietary intervention<br>* Intervention include low sodium or usual sodium diet<br>|
| Active Comparator: Usual sodium diet<br>This group will get a usual sodium diet ( 2 mg per kcal of energy intake). | Other: Dietary intervention<br>* Intervention include low sodium or usual sodium diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seated Blood Pressure | Average of three seated systolic and diastolic blood pressure readings | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthostatic Hypotension | Measured from supine and standing systolic and diastolic blood pressure readings | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sodium Intake, Blood Pressure, Hypertension, Physical Function, Older Adults, Randomized Controlled Trial