HypertensionSOTRUENCT04074941
The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults
A study testing Dietary intervention in people with Hypertension and Physical Disability, run by Hebrew SeniorLife at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Physical Disability, Aging
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2019to 4 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension, Physical Disability, Aging
- Being tested
- Dietary intervention
- Keywords
- Sodium Intake, Blood Pressure, Hypertension, Physical Function, Older Adults, Randomized Controlled Trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Intervention include low sodium or usual sodium diet
| Study group | Role | What they receive |
|---|---|---|
| Low sodium diet | Experimental | This group will get a low sodium diet (<0.9 mg per kcal of energy intake). Receives: Other: Dietary intervention |
| Usual sodium diet | Active comparator | This group will get a usual sodium diet (~2 mg per kcal of energy intake). Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated Blood Pressure
Average of three seated systolic and diastolic blood pressure readings
Measured: 2 weeks
Secondary outcomes (1)
Orthostatic Hypotension
Measured from supine and standing systolic and diastolic blood pressure readings
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start30 Aug 2019
- Primary completion1 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Shivani Sahni, Hebrew SeniorLife
- Investigators
- Shivani Sahni, PhD, Principal investigator, Marcus Institute, Hebrew SeniorLife and Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074941
- Sponsor's protocol ID
- IRB-2019-22
- Acronym
- SOTRUE
- Status last verified
- Apr 2021
- First submitted
- 28 Aug 2019
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults
- ClinicalTrials.gov ID
- NCT04074941
- Acronym / sponsor ID
- SOTRUE / IRB-2019-22
- Conditions
- Hypertension, Physical Disability, Aging
- Keywords
- Sodium Intake, Blood Pressure, Hypertension, Physical Function, Older Adults, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either a low sodium diet or a usual sodium diet for a period of two weeks.
| Arm | Type | Receives |
|---|---|---|
| Low sodium diet | Experimental | Other: Dietary interventionThis group will get a low sodium diet (<0.9 mg per kcal of energy intake). |
| Usual sodium diet | Active comparator | Other: Dietary interventionThis group will get a usual sodium diet (~2 mg per kcal of energy intake). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionIntervention include low sodium or usual sodium diet | Other | Low sodium diet, Usual sodium diet |
Primary outcome
Seated Blood Pressure
Time frame: 2 weeks
Average of three seated systolic and diastolic blood pressure readings
1 secondary outcome
Orthostatic Hypotension
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shivani Sahni, PhD principal investigator
Marcus Institute, Hebrew SeniorLife and Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Hypertension and Physical Disability, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seated Blood Pressure (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.