Acute Equol Supplementation and Vascular Function in Women With and Without CKD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50-69
SponsorUniversity of Colorado, Denver
About this trial
The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in nephrology focuses on male patients, and studies on women's vascular health are limited. Establishing effective therapies for improving vascular function and reducing CVD risk in women with CKD is a high research priority of the NIH.
Equol contributes to improvement in vascular function, mediated in part by its anti-oxidative and anti-inflammatory properties. However, there is no information on the effect of equol on vascular function in women with CKD. The proposed project aims to determine the acute effect (1-hour, 2-hours, and 3-hours post ingestion) of oral equol supplementation on vascular function in postmenopausal women with and without CKD.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Postmenopausal (50-69 y) women
Women with CKD including stage 3-4 (eGFR 15-59 ml/min/1.73m2) determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 equation
Women without CKD (eGFR >60 ml/min/1.73m2) must be healthy (free from hypertension, kidney disease, CVD, diabetes, and other chronic disease as assessed by self-report, medical history, and screening labs).
Disqualifiers
Use of HRT or has used HRT for <6 months prior to enrollment
Advanced CKD requiring dialysis
History of kidney transplant
Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease)
Trial design
Design model
Crossover
Treatments tested in this trial
S-equol
DrugOral supplementation of S-equol
Placebo
Other interventionOral supplementation of placebo
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: (1) S-equol, (2) PlaceboExperimental treatment 2 interventions
Group B: (1) Placebo, (2) S-equolExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Brachial Artery Flow-Mediated Dilation
Flow-mediated dilation of the brachial artery will be performed using ultrasonography and analyzed with a commercially available software package as percent change in diameter from baseline following reactive hyperemia.
Time frame
Baseline; 1-hour, 2-hours, and 3-hours post ingestionSecondary outcomes
1
Change in Carotid Femoral Pulse Wave Velocity
A transcutaneous custom tonometer \[Noninvasive Hemodynamics Workstation (NIHem), Cardiovascular Engineering Inc.\] will be used to non-invasively assess carotid femoral pulse wave velocity.
Time frame
Baseline; 2-hour post ingestion2
Change in oxidative stress markers
8-isoprostane
Time frame
Baseline; 1-hour, 2-hours, and 3-hours post ingestion3
Change in inflammation markers
interleukin-6, tumor necrosis factor-α
Time frame
Baseline; 1-hour, 2-hours, and 3-hours post ingestion4
Change in S-equol concentrations
Plasma S-equol levels
Time frame
Baseline; 1-hour, 2-hours, and 3-hours post ingestionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov