Sodium vs Potassium Education to Improve Vascular Health

ConditionHealthy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

SponsorFlorida State University

About this trial

The goal of this clinical trial is to determine if a self-selected high potassium diet is easier to achieve and more effective at improving vascular health than a low sodium diet in generally healthy young adults who typically consume more than the recommended amount of sodium. The main questions it aims to answer are:

1. Is it easier for young adults to increase their potassium intake, rather than reduce their sodium intake? 2. Is a self-selected high potassium diet better at improving vascular health compared to a self-selected low sodium diet?

Researchers will compare the effectiveness of an education-based intervention centered only on increasing dietary potassium intake against an education-based intervention centered only on reducing dietary sodium intake.

Participants will be randomly assigned to receive comprehensive dietary education on adopting either a high-potassium diet or a low-sodium diet.

Education will be delivered in four weekly one-on-one sessions. Following the four-week education period, participants will be encouraged to change their diet based on what they have learned. Measures of dietary compliance (urine samples and diet records) and cardiovascular health (blood pressure, endothelial function) will be assessed at two, four, and six months post-education.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Willing and able to attend in-person laboratory visits

Usual sodium intake ≥3,000 mg/d for females and ≥4,000 mg/d for males

Usual potassium intake ≤2,500 mg/d in females and ≤3,000 mg/d in males

Disqualifiers

BMI ≥35 kg/m2

Seated blood pressure ≥130/80 mmHg

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

Current or recent use of a diuretic (within the past 6 months)

Trial design

Design model

Parallel

Treatments tested in this trial

High potassium dietary education/counseling
Behavioral
Participants assigned to this intervention arm will receive four weekly individualized education sessions on how to increase their dietary potassium intake.
Low sodium dietary education/counseling
Behavioral
Participants assigned to this intervention arm will receive four weekly individualized education sessions on how to reduce their dietary sodium intake.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: High potassium dietary educationExperimental treatment 1 intervention

Group B: Low sodium dietary educationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in dietary sodium intake

Dietary sodium intake will be assessed via participant self-reported 3 day diet record

Time frame

Baseline; 2 month, 4month, 6month

Change in dietary potassium intake

Dietary potassium intake will be assessed via participant self-reported 3-day diet record

Time frame

Baseline, 2month, 4month, 6month

Change in 24-hour urinary sodium excretion

Urinary sodium excretion obtained from 24-hour urine sample

Time frame

Baseline, 2month, 4month, 6month

Change in 24-hour urinary potassium excretion

Urinary potassium excretion measured from 24-hour urine sample

Time frame

Baseline, 2month, 4month, 6month

Secondary outcomes

Direct measurement of arterial stiffness

Carotid-femoral pulse wave velocity reported in m/s

Time frame

Baseline, 2month, 4month, 6month

Indirect measurement of arterial stiffness

Augmentation obtained from the brachial artery pressure waveform using a blood pressure cuff on the upper arm, reported as %

Time frame

Baseline, 2month, 4month, 6month

Other outcomes

Change in Body weight

body weight assessed in kilograms

Time frame

Baseline; 2 month, 4month, 6month

Change in total cholesterol

Fasting total cholesterol obtained as part of standard lipid panel

Time frame

Baseline, 2month, 4month, 6month

Change in LDL cholesterol

Fasting LDL cholesterol obtained as part of a standard lipid panel

Time frame

Baseline, 2month, 4month, 6month

Change in HDL cholesterol

Fasting HDL cholesterol obtained as part of a standard lipid panel

Time frame

Baseline, 2month, 4month, 6month

Sponsors and contacts

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

Florida State University

Lead sponsor

United States Department of Agriculture (USDA)

Collaborator

Source ClinicalTrials.gov

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