Sodium vs Potassium Education to Improve Vascular Health

Improving Vascular Health Using Nutrition Education Aimed At Increasing Potassium Intake Versus Reducing Sodium Intake

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Behavioral: High potassium dietary education/counseling; Behavioral: Low sodium dietary education/counseling

Detailed Description

High sodium diets are a major contributor to cardiovascular disease. Unfortunately, reducing sodium intake can be challenging. It is known that increasing potassium intake can improve cardiovascular disease risk factors in a laboratory setting. The investigators are hoping to show that it is more feasible and effective for individuals to increase their potassium intake, rather than reduce their sodium intake, to improve cardiovascular disease risk factors, including blood pressure and endothelial function.

In this study, participants will be randomly assigned to receive individualized education over the course of four weeks to help them adopt one of two dietary patterns: 1) a self-selected low sodium diet (goal: ≤1,500 mg/day) or 2) a self-selected high potassium diet (goal: ≥4,700 mg/day). Participants will be provided individualized nutrition education once per week, at the participant's convenience by trained study staff to help them meet the target nutrition goals. No food, supplements, or devices will be provided to participants, and participants will be advised not to take any dietary supplements containing potassium during the intervention and follow-up period. Follow up with participants will be every two months for six months post-education to measure compliance with the desired dietary changes as well as changes in cardiovascular health.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Lobene, PhD, RD, LD; Phone Number: 850-644-1829; Email: alobene@fsu.edu
• Study Contact Backup: Name: FSU Ann's College; Phone Number: 850-644-6685

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32304
      • Recruiting
      • Florida State University
      • Contact: Andrea Lobene, PhD, RD, LD; Phone Number: 850-644-1829; Email: alobene@fsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• Elevated blood lipids (LDL cholesterol ≥190 mg/dL)
• Elevated serum potassium level (>5.1 mmol/L)
• Elevated BUN (>22 mg/dL)
• Elevated creatinine (>1.2 mg/dL)
• Low eGFR (<90 mL/min/1.73 m²)
• Current or recent use of tobacco, nicotine, or illicit drugs
• Radical hysterectomy or oophorectomy (females)*
• Pregnant or lactating
• Following a weight-loss diet, or intending to gain or lose weight during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High potassium dietary education	Behavioral: High potassium dietary education/counseling; Participants assigned to this intervention arm will receive four weekly individualized education sessions on how to increase their dietary potassium intake.
Active Comparator: Low sodium dietary education	Behavioral: Low sodium dietary education/counseling; Participants assigned to this intervention arm will receive four weekly individualized education sessions on how to reduce their dietary sodium intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dietary sodium intake	Dietary sodium intake will be assessed via participant self-reported 3 day diet record	Baseline; 2 month, 4month, 6month
Change in dietary potassium intake	Dietary potassium intake will be assessed via participant self-reported 3-day diet record	Baseline, 2month, 4month, 6month
Change in 24-hour urinary sodium excretion	Urinary sodium excretion obtained from 24-hour urine sample	Baseline, 2month, 4month, 6month
Change in 24-hour urinary potassium excretion	Urinary potassium excretion measured from 24-hour urine sample	Baseline, 2month, 4month, 6month
Change in Blood pressure	Seated, automated blood pressure mmHg	Baseline; 2 month, 4month, 6month
Change in Endothelial function	brachial artery flow-mediated dilation as measured in % dilation	Baseline; 2 month, 4month, 6month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct measurement of arterial stiffness	Carotid-femoral pulse wave velocity reported in m/s	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 %	Baseline, 2month, 4month, 6month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body weight	body weight assessed in kilograms	Baseline; 2 month, 4month, 6month
Change in total cholesterol	Fasting total cholesterol obtained as part of standard lipid panel	Baseline, 2month, 4month, 6month
Change in LDL cholesterol	Fasting LDL cholesterol obtained as part of a standard lipid panel	Baseline, 2month, 4month, 6month
Change in HDL cholesterol	Fasting HDL cholesterol obtained as part of a standard lipid panel	Baseline, 2month, 4month, 6month
Change in triglycerides	Fasting triglycerides obtained as part of a standard lipid panel	Baseline, 2month, 4month, 6month

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: United States Department of Agriculture (USDA)
• Investigators: Principal Investigator: Andrea Lobene, PhD, RD, LD, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: October 24, 2025
• First Posted (Actual): October 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: nutrition education; potassium; endothelial function; sodium; cardiovascular disease risk factors
• Additional Relevant MeSH Terms: Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Counseling
• Other Study ID Numbers: STUDY00005997; 2025-67017-44996 (Other Grant/Funding Number: United States Department of Agriculture)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No