Recruiting

High Potassium & Low Sodium

Sponsor:

Florida State University

Code:

NCT07221448

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

High potassium dietary education/counseling

Low sodium dietary education/counseling

Study Details

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. 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.

Conditions

Healthy

Study ID

NCT07221448

Start date

Apr 20, 2026

Status verified date

Feb, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: High potassium dietary education

active comparator: Low sodium dietary education

Interventions

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.

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.

Primary outcome measure

  • Change in dietary sodium intake [ Time Frame: Baseline; 2 month, 4month, 6month ]
  • Change in dietary potassium intake [ Time Frame: Baseline, 2month, 4month, 6month ]
  • Change in 24-hour urinary sodium excretion [ Time Frame: Baseline, 2month, 4month, 6month ]
  • Change in 24-hour urinary potassium excretion [ Time Frame: Baseline, 2month, 4month, 6month ]
  • Change in Blood pressure [ Time Frame: Baseline; 2 month, 4month, 6month ]
  • Change in Endothelial function [ Time Frame: Baseline; 2 month, 4month, 6month ]

Central Contacts and Locations

Central contacts

Andrea Lobene, PhD, RD, LD

850-644-1829alobene@fsu.edu

FSU Ann's College

850-644-6685

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32304

Contacts

Andrea Lobene, PhD, RD, LD

850-644-1829alobene@fsu.edu

More Information

Sponsor

Florida State University

Last update posted

Apr 23, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Florida State University on 2026-04-23.