Interactive Effects of Sodium and Potassium on Vascular Health in Older Adults
11 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: FSU Ann's College
- Numéro de téléphone: 850-644-6685
Sauvegarde des contacts de l'étude
- Nom: Andrea Lobene
- Numéro de téléphone: 850-644-1829
- E-mail: alobene@fsu.edu
Lieux d'étude
-
-
Florida
-
Tallahassee, Florida, États-Unis, 32306
- Recrutement
- Florida State University
-
Contact:
- Andrea Lobene
- Numéro de téléphone: 850-644-1829
- E-mail: alobene@fsu.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Endothelial function
Délai: "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
Délai: "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
Délai: "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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Andrea Lobene, Florida State University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
24 mars 2026
Achèvement primaire (Estimé)
30 juin 2027
Achèvement de l'étude (Estimé)
30 juin 2027
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
11 juin 2026
Première publication (Réel)
15 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- STUDY00006676
- UF-FSU CTSA Career Development (Autre subvention/numéro de financement: UF-FSU Clinical and Translational Science Award)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .