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

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ClinicalTrials.gov Identifier: NCT04074941
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborators:
Hebrew SeniorLife
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Shivani Sahni, Hebrew Rehabilitation Center, Boston

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.

Condition or disease Intervention/treatment Phase
Hypertension Physical Disability Aging Other: Dietary intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, 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).
Primary Purpose: Prevention
Official Title: The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Seated blood pressure [ Time Frame: 2 weeks ]
    Average of three seated systolic and diastolic blood pressure readings


Secondary Outcome Measures :
  1. Orthostatic hypotension [ Time Frame: 2 weeks ]
    Measured from supine and standing systolic and diastolic blood pressure readings


Other Outcome Measures:
  1. Timed up and go test [ Time Frame: 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Resident at Jack Satter House in Revere
  • Age >= 60 years
  • Resting systolic blood pressure 120-159 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 <23)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074941


Contacts
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Contact: Shivani Sahni, PhD 617-971-5382 shivanisahni@hsl.harvard.edu
Contact: Stephen P. Juraschek, MD, PhD (617) 754-9600 sjurasch@bidmc.harvard.edu

Locations
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United States, Massachusetts
Jack Satter House Recruiting
Revere, Massachusetts, United States, 02151
Contact: Pamela Richmond    617-971-5415    PamelaRichmond@hsl.harvard.edu   
Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
Hebrew SeniorLife
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Shivani Sahni, PhD Marcus Institute, Hebrew SeniorLife and Harvard Medical School

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Responsible Party: Shivani Sahni, Associate Scientist, Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier: NCT04074941     History of Changes
Other Study ID Numbers: IRB-2019-22
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shivani Sahni, Hebrew Rehabilitation Center, Boston:
Sodium Intake
Blood Pressure
Hypertension
Physical Function
Older Adults
Randomized Controlled Trial
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases