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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Aging; Physical Disability
• Intervention / Treatment: Other: Dietary intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Revere, Massachusetts, United States, 02151
      • Jack Satter House

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks

Collaborators and Investigators

• Sponsor: Hebrew SeniorLife
• Collaborators: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Shivani Sahni, PhD, Marcus Institute, Hebrew SeniorLife and Harvard Medical School

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 4, 2019

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Older Adults; Randomized Controlled Trial; Physical Function; Blood Pressure; Sodium Intake
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IRB-2019-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No