Florida State University
Tallahassee, Florida, 32304, United States
Location status: Recruiting
NCT Number: NCT07221448
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Tallahassee, Florida, 32304, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants assigned to this intervention arm will receive four weekly individualized education sessions on how to increase their dietary potassium intake.
Participants assigned to this intervention arm will receive four weekly individualized education sessions on how to reduce their dietary sodium intake.
Time frame: Baseline; 2 month, 4month, 6month
Dietary sodium intake will be assessed via participant self-reported 3 day diet record
Time frame: Baseline, 2month, 4month, 6month
Dietary potassium intake will be assessed via participant self-reported 3-day diet record
Time frame: Baseline, 2month, 4month, 6month
Urinary sodium excretion obtained from 24-hour urine sample
Time frame: Baseline, 2month, 4month, 6month
Urinary potassium excretion measured from 24-hour urine sample
Time frame: Baseline; 2 month, 4month, 6month
Seated, automated blood pressure mmHg
Time frame: Baseline; 2 month, 4month, 6month
brachial artery flow-mediated dilation as measured in % dilation
Time frame: Baseline, 2month, 4month, 6month
Carotid-femoral pulse wave velocity reported in m/s
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 %
Time frame: Baseline; 2 month, 4month, 6month
body weight assessed in kilograms
Time frame: Baseline, 2month, 4month, 6month
Fasting total cholesterol obtained as part of standard lipid panel
Time frame: Baseline, 2month, 4month, 6month
Fasting LDL cholesterol obtained as part of a standard lipid panel
Time frame: Baseline, 2month, 4month, 6month
Fasting HDL cholesterol obtained as part of a standard lipid panel
Time frame: Baseline, 2month, 4month, 6month
Fasting triglycerides obtained as part of a standard lipid panel
Contact information is provided by the study sponsor or research team.
Andrea Lobene, PhD, RD, LD
CONTACT
FSU Ann's College
CONTACT
Florida State University
Other
Improving Vascular Health Using Nutrition Education Aimed At Increasing Potassium Intake Versus Reducing Sodium Intake
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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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