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NCT Number: NCT07221448

Sodium vs Potassium Education to Improve Vascular Health

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32304, United States

Location status: Recruiting

Location contact

Andrea Lobene, PhD, RD, LD

CONTACT

[email protected]

850-644-1829

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in dietary sodium intake

    Time frame: Baseline; 2 month, 4month, 6month

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

  2. Change in dietary potassium intake

    Time frame: Baseline, 2month, 4month, 6month

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

  3. Change in 24-hour urinary sodium excretion

    Time frame: Baseline, 2month, 4month, 6month

    Urinary sodium excretion obtained from 24-hour urine sample

  4. Change in 24-hour urinary potassium excretion

    Time frame: Baseline, 2month, 4month, 6month

    Urinary potassium excretion measured from 24-hour urine sample

  5. Change in Blood pressure

    Time frame: Baseline; 2 month, 4month, 6month

    Seated, automated blood pressure mmHg

  6. Change in Endothelial function

    Time frame: Baseline; 2 month, 4month, 6month

    brachial artery flow-mediated dilation as measured in % dilation

Secondary outcomes

  1. Direct measurement of arterial stiffness

    Time frame: Baseline, 2month, 4month, 6month

    Carotid-femoral pulse wave velocity reported in m/s

  2. Indirect measurement of arterial stiffness

    Time frame: Baseline, 2month, 4month, 6month

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

Other outcomes

  1. Change in Body weight

    Time frame: Baseline; 2 month, 4month, 6month

    body weight assessed in kilograms

  2. Change in total cholesterol

    Time frame: Baseline, 2month, 4month, 6month

    Fasting total cholesterol obtained as part of standard lipid panel

  3. Change in LDL cholesterol

    Time frame: Baseline, 2month, 4month, 6month

    Fasting LDL cholesterol obtained as part of a standard lipid panel

  4. Change in HDL cholesterol

    Time frame: Baseline, 2month, 4month, 6month

    Fasting HDL cholesterol obtained as part of a standard lipid panel

  5. Change in triglycerides

    Time frame: Baseline, 2month, 4month, 6month

    Fasting triglycerides obtained as part of a standard lipid panel

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Lobene, PhD, RD, LD

CONTACT

[email protected]

850-644-1829

FSU Ann's College

CONTACT

850-644-6685

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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