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

NCT04074941 | Completed Results

• 1 other identifier: IRB-2019-22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Physical Disability; Aging

Keywords

Sodium Intake; Blood Pressure; Hypertension; Physical Function; Older Adults; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Seated Blood Pressure

  Average of three seated systolic and diastolic blood pressure readings

  2 weeks

Secondary Outcomes (1)

• Orthostatic Hypotension

  2 weeks

Other Outcomes (1)

• Timed up and go Test

  2 weeks

Study Arms (2)

Low sodium diet

EXPERIMENTAL

This group will get a low sodium diet (\<0.9 mg per kcal of energy intake).

Other: Dietary intervention

Usual sodium diet

ACTIVE COMPARATOR

This group will get a usual sodium diet (\~2 mg per kcal of energy intake).

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Intervention include low sodium or usual sodium diet

Low sodium diet; Usual sodium diet

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew SeniorLife: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Jack Satter House

Revere, Massachusetts, 02151, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Limitations and Caveats

Limitations include low powered, which was expected as we fell short of recruitment goals and enrolled adults without elevated blood pressure. Our study lasted a short duration. Effects from sodium on BP may take up to 4 weeks, while effects on physical function may require even more time to occur. Our study included predominantly White obese females which limits generalizability.

Results Point of Contact

• Title: Shivani Sahni, PhD
• Organization: Marcus Institute, Hebrew SeniorLife

shivanisahni@hsl.harvard.edu

6179715382

Study Officials

• Shivani Sahni, PhD

  Marcus Institute, Hebrew SeniorLife and Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study staff involved in administering the dietary intervention and assessing compliance will be masked to participants' outcome assessments (e.g. BP).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Model Details: Participants will be randomized to either a low sodium diet or a usual sodium diet for a period of two weeks.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: August 30, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 4, 2019
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)