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

Qualifiers

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

Treatments tested in this trial

  • S-equol
  • Placebo

Treatment groups

38 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

American Heart Association

Collaborator