Equol and Vascular Function in Women With Chronic Kidney Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50+
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 effect of 12 weeks of oral equol supplementation on vascular function in postmenopausal women with CKD.

Eligibility criteria

Qualifiers

Postmenopausal women

Aged ≥50 years

CKD stage 3 or 4 (eGFR with the CKD-EPI 2021 race-free equation: 15-59 mL/min/1.73m2; stable renal function in the past 3 months)

Low habitual intake of soy (soy-related food intake < 2 times per week assessed by Soy-Specific Food Frequency Questionnaire)

Disqualifiers

Patients with advanced CKD requiring chronic dialysis

Uncontrolled hypertension in CKD group (BP >140/90 mmHg)

Use of any hormone replacement therapy

Allergy and/or intolerance to soy or soy-based products

Trial design

Treatments tested in this trial

  • Equol
  • Placebo

Treatment groups

74 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator