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Interactive Effects of Sodium and Potassium on Vascular Health in Older Adults

ConditionHealthy Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorFlorida State University

About this trial

The goal of this clinical trial is to determine if a high potassium intake can counteract the harmful effects of excess sodium on endothelial function in older adults with no history of cardiometabolic disease. The main questions it aims to answer are:

1. Can a high potassium intake attenuate dietary sodium-induced endothelial dysfunction in older adults. 2. Do changes in endothelial function in response to alterations in sodium and potassium intake differ by sex.

Participants will participants will consume three controlled diets for 10 days each with a minimum 14-day washout between interventions. The order in which participants consume the diets will be randomized. The study diets will vary in sodium and potassium content. Measures of cardiovascular health (blood pressure, arterial stiffness, endothelial function) will be assessed at the end of each diet.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults ages 55-75 years

At least one-year post-menopause (females)

Willing and able to attend laboratory visits

Disqualifiers

BMI ≥35 kg/m2

Seated blood pressure >135/85 mmHg

Current diagnosis or history of cardiovascular disease, diabetes, renal disease, cancer, or major cardiovascular event (e.g. heart attack or stroke)

Taking exogenous hormones or hormone replacement therapy

Trial design

Design model

Crossover

Treatments tested in this trial

  • low sodium/low potassium diet

    Other intervention

    On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day

  • high sodium/low potassium diet

    Other intervention

    On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day

  • high sodium/high potassium diet

    Other intervention

    On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day

Treatment groups

30 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: low Na/low K, high Na/low K, high Na/high KExperimental treatment 3 interventions
Group B: low Na/low K, high Na/high K, high Na/low KExperimental treatment 3 interventions
Group C: high Na/high K, low Na/low K, high Na/low KExperimental treatment 3 interventions
Group D: high Na/high K, high Na/low K, low Na/low KExperimental treatment 3 interventions
Group E: high Na/low K, low Na/low K, high Na/high KExperimental treatment 3 interventions
Group F: high Na/low K, high Na/high K, low Na/low KExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Endothelial function

Brachial artery flow-mediated dilation as measured in % dilation

Time frame
"Day 11" after each of the three 10-day dietary interventions
2

Blood pressure

24-hour ambulatory blood pressure

Time frame
"Day 11" after each of the three 10-day dietary interventions
3

Arterial stiffness

Carotid-femoral pulse wave velocity

Time frame
"Day 11" after each of the three 10-day dietary interventions

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida State University

Lead sponsor

University of Florida

Collaborator

Source ClinicalTrials.gov
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