Interactive Effects of Sodium and Potassium on Vascular Health in Older Adults
11 juni 2026 uppdaterad av: Andrea Lobene, Florida State University
Exploring the Interactive Effects of Sodium and Potassium Intake on Vascular Health in Older Adults
The goal of this clinical trial is to determine if a high potassium intake can counteract the harmful effects of excess sodium on endothelial function in older adults with no history of cardiometabolic disease. The main questions it aims to answer are:
- Can a high potassium intake attenuate dietary sodium-induced endothelial dysfunction in older adults.
- Do changes in endothelial function in response to alterations in sodium and potassium intake differ by sex.
Participants will participants will consume three controlled diets for 10 days each with a minimum 14-day washout between interventions. The order in which participants consume the diets will be randomized. The study diets will vary in sodium and potassium content. Measures of cardiovascular health (blood pressure, arterial stiffness, endothelial function) will be assessed at the end of each diet.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Cardiovascular health declines with age, especially in postmenopausal females.
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 young adults, even if sodium intake remains high.
The investigators are hoping to show that potassium can improve cardiovascular health in the context of a high sodium diets in older adults.
In this study, participants will consume three 10-day controlled diets in a randomized order.
The study diets will include: 1) a low sodium (2,000 mg/day)/low potassium (2,000 mg/day) diet; 2) a high sodium (4,700 mg/day)/usual potassium diet; and 3) a high sodium/high potassium (4,700 mg/day).
All food will be provided to participants during these periods, and participants will be instructed not to consume any outside food or beverages.
Dietary interventions will be separated by a minimum two-week washout period.
Measurements of cardiovascular health will be collected at the end of each diet.
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: FSU Ann's College
- Telefonnummer: 850-644-6685
Studera Kontakt Backup
- Namn: Andrea Lobene
- Telefonnummer: 850-644-1829
- E-post: alobene@fsu.edu
Studieorter
-
-
Florida
-
Tallahassee, Florida, Förenta staterna, 32306
- Rekrytering
- Florida State University
-
Kontakt:
- Andrea Lobene
- Telefonnummer: 850-644-1829
- E-post: alobene@fsu.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- Adults ages 55-75 years
- At least one-year post-menopause (females)
- Willing and able to attend laboratory visits
Exclusion Criteria:
- BMI ≥35 kg/m2
- Seated blood pressure >135/85 mmHg
- Current diagnosis or history of cardiovascular disease, diabetes, renal disease, cancer, or major cardiovascular event (e.g. heart attack or stroke)
- Taking exogenous hormones or hormone replacement therapy
- Following a vegan or gluten free diet
- Significant weight loss (>10% of body weight) in the last 6 months, or actively trying to lose weight
- Current or recent use of a diuretic (within the past 6 months) (e.g. spironolactone, eplerenone)
- Current or recent use of a potassium binding medication (within the past 6 months)
- Current use of blood pressure lowering medications (e.g. ACE inhibitors, calcium channel blockers, diuretics, vasodilators, beta blockers, AngII receptor blockers)
- Current or recent use of the medication trimethoprim
- 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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: low Na/low K, high Na/low K, high Na/high K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content.
There is a minimum 2-week washout between diets.
|
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
|
|
Experimentell: low Na/low K, high Na/high K, high Na/low K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content.
There is a minimum 2-week washout between diets.
|
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
|
|
Experimentell: high Na/high K, low Na/low K, high Na/low K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content.
There is a minimum 2-week washout between diets.
|
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
|
|
Experimentell: high Na/high K, high Na/low K, low Na/low K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content.
There is a minimum 2-week washout between diets.
|
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
|
|
Experimentell: high Na/low K, low Na/low K, high Na/high K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content.
There is a minimum 2-week washout between diets.
|
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
|
|
Experimentell: high Na/low K, high Na/high K, low Na/low K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content.
There is a minimum 2-week washout between diets.
|
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Endothelial function
Tidsram: "Day 11" after each of the three 10-day dietary interventions
|
Brachial artery flow-mediated dilation as measured in % dilation
|
"Day 11" after each of the three 10-day dietary interventions
|
|
Blood pressure
Tidsram: "Day 11" after each of the three 10-day dietary interventions
|
24-hour ambulatory blood pressure
|
"Day 11" after each of the three 10-day dietary interventions
|
|
Arterial stiffness
Tidsram: "Day 11" after each of the three 10-day dietary interventions
|
Carotid-femoral pulse wave velocity
|
"Day 11" after each of the three 10-day dietary interventions
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Andrea Lobene, Florida State University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
24 mars 2026
Primärt slutförande (Beräknad)
30 juni 2027
Avslutad studie (Beräknad)
30 juni 2027
Studieregistreringsdatum
Först inskickad
9 juni 2026
Först inskickad som uppfyllde QC-kriterierna
11 juni 2026
Första postat (Faktisk)
15 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- STUDY00006676
- UF-FSU CTSA Career Development (Annat bidrag/finansieringsnummer: UF-FSU Clinical and Translational Science Award)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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