NCT04074941: SOTRUE

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

Completed NA Results posted Last updated 11 May 2021

What this trial tests

NA trial testing Dietary intervention in Hypertension in 20 participants. Completed in 4 November 2019.

Timeline

30 August 2019

Primary endpoint
1 November 2019

4 November 2019

Quick facts

Lead sponsor	Hebrew SeniorLife
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	20
Start date	30 August 2019
Primary completion	1 November 2019
Estimated completion	4 November 2019
Sites	1 location across United States

Drugs / interventions tested

• Dietary intervention

Conditions studied

• Hypertension — all drugs for Hypertension →
• Physical Disability — all drugs for Physical Disability →
• Aging — all drugs for Aging →

Sponsor

Hebrew SeniorLife — full company profile →

Who can join

60 and older, any sex, with Hypertension or Physical Disability. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Seated Blood Pressure Primary · 2 weeks

Average of three seated systolic and diastolic blood pressure readings

Follow-up seated systolic blood pressure

Group	Value	95% CI
Low Sodium Diet	112.1	± 7.6
Usual Sodium Diet	116.1	± 13.0

Follow-up seated diastolic blood pressure

Group	Value	95% CI
Low Sodium Diet	60.3	± 9.6
Usual Sodium Diet	60.4	± 8.0

Orthostatic Hypotension Secondary · 2 weeks

Measured from supine and standing systolic and diastolic blood pressure readings

Group	Value	95% CI
Low Sodium Diet	3
Usual Sodium Diet	5

Timed up and go Test Secondary · 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.

Group	Value	95% CI
Low Sodium Diet	13.8	± 5.6
Usual Sodium Diet	13.8	± 4.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Low Sodium Diet

Serious: 0/11 (0%)

Deaths: 0/11

Usual Sodium Diet

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (1 terms — click to expand)

Reaction	System	Low Sodium Diet	Usual Sodium Diet
High blood glucose in participants with baseline diabetes	Endocrine disorders	—	—

Data from ClinicalTrials.gov NCT04074941 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial.
   Juraschek SP, Millar CL, Foley A, Shtivelman M, et al · · 2021 · cited 2× · PMID 33809796 · DOI 10.3390/nu13030964
2. The Feasibility of Using Computrition Software for Nutrition Research-A Pilot Study.
   Millar CL, Cohen A, Juraschek SP, Foley A, et al · · 2021 · PMID 33498640 · DOI 10.3390/nu13020329