Clinical trial NCT04074941: The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults
Official title: The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Physical Disability
Aging
Keywords: Sodium Intake
Blood Pressure
Hypertension
Physical Function
Older Adults
Randomized Controlled Trial
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2019-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either a low sodium diet or a usual sodium diet for a period of two weeks.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seated Blood Pressure
timeFrame: 2 weeks
Secondary outcomes:
measure: Orthostatic Hypotension
timeFrame: 2 weeks
Other outcomes:
measure: Timed up and go Test
timeFrame: 2 weeks
Locations:
city: Revere
country: United States
facility: Jack Satter House
state: Massachusetts
Study officials:
affiliation: Marcus Institute, Hebrew SeniorLife and Harvard Medical School
name: Shivani Sahni, PhD
role: PRINCIPAL_INVESTIGATOR
References: