Recruiting
Phase 2

Equol

Sponsor:

University of Colorado, Denver

Code:

NCT07194590

Conditions

Chronic Kidney Disease (Stage 3-4)

Vascular Function

Cognitive Functions

Cerebrovascular Function

Blood Pressure

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Equol

Placebo

Study Details

Brief summary:

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.

Conditions

Chronic Kidney Disease (Stage 3-4)

Vascular Function

Cognitive Functions

Cerebrovascular Function

Blood Pressure

Study ID

NCT07194590

Start date

Feb 19, 2026

Status verified date

Sep, 2025

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)
  • Weight stable in the prior 3 months (<2 kg weight change) and willing to remain weight stable throughout the study
  • Ability to provide informed consent.

Exclusion Criteria:

  • 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
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin values 2X upper limit of normal range (upper limit of normal range AST: 117 U/L; ALT: 52 U/L; total bilirubin: 1.3 mg/dL)
  • History of breast cancer
  • Significant co-morbid conditions with a life expectancy of < 1 year
  • Current tobacco or nicotine use or history of use in the last 12 months
  • History of kidney transplant
  • History of severe congestive heart failure (i.e., ejection fraction <35%)
  • History of hospitalization within the last month
  • Immunosuppressant agents taken in the past 12 months
  • Known malignancy

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Equol

This group will receive 10 mg equol per day (2 capsules/day, 5mg equol/capsule).

placebo comparator: Placebo

This group will receive 2 placebo capsules per day.

Interventions

Equol

This group will receive 10 mg equol per day (2 capsules/day, 5mg equol/capsule).

Placebo

This group will receive 2 placebo capsules per day.

Primary outcome measure

  • Brachial Artery Flow-Mediated Dilation (FMDBA) [ Time Frame: Baseline, 12 weeksv ]

Central Contacts and Locations

Central contacts

Ester Oh, PhD

303-724-3765ester.oh@cuanschutz.edu

Emily Andrews

303-724-7790

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emily Andrews

303-724-2275EMILY.S.ANDREWS@CUANSCHUTZ.EDU

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 2, 2026

Last verified

Sep, 2025

Keywords

  • S-equol
  • Randomized Controlled Trial
  • Chronic Kidney Disease
  • Women&#39;s Health
  • Vascular Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-02.