Sodium vs Potassium Education to Improve Vascular Health

NCT07221448 | Recruiting

• 2 other identifiers: STUDY000059972025-67017-44996
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

sodium; potassium; nutrition education; endothelial function; cardiovascular disease risk factors

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Direct measurement of arterial stiffness

  Baseline, 2month, 4month, 6month

• Indirect measurement of arterial stiffness

  Baseline, 2month, 4month, 6month

Other Outcomes (5)

• Change in Body weight

  Baseline; 2 month, 4month, 6month

• Change in total cholesterol

  Baseline, 2month, 4month, 6month

• Change in LDL cholesterol

  Baseline, 2month, 4month, 6month

Study Arms (2)

High potassium dietary education

EXPERIMENTAL

Behavioral: High potassium dietary education/counseling

Low sodium dietary education

ACTIVE COMPARATOR

Behavioral: Low sodium dietary education/counseling

Interventions

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.

High potassium dietary education

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.

Low sodium dietary education

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

RECRUITING

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andrea Lobene, PhD, RD, LD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Lobene, PhD, RD, LD

CONTACT

850-644-1829; alobene@fsu.edu

FSU Ann's College

CONTACT

850-644-6685

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 28, 2025
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)