Recruiting
Phase 2

Equol

Sponsor:

University of Colorado, Denver

Code:

NCT06128278

Conditions

Chronic Kidney Diseases

Vascular Function

Women

Eligibility Criteria

Sex: Female

Age: 50 - 69

Healthy Volunteers: Accepted

Interventions

S-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 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.

Conditions

Chronic Kidney Diseases

Vascular Function

Women

Study ID

NCT06128278

Start date

Mar 7, 2023

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50 - 69

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Postmenopausal (50-69 y) women
2. 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
3. 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).

Exclusion Criteria:

1. Use of HRT or has used HRT for <6 months prior to enrollment
2. Advanced CKD requiring dialysis
3. History of kidney transplant
4. Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease)
5. Current tobacco or nicotine use or history of use in the last 12 months
6. Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
7. Marijuana use within 2 weeks prior to testing
8. Consumption of soy and soy-based products 3 days prior to testing
9. Uncontrolled hypertension in CKD group (BP>140/90 mmHg)
10. Atrial fibrillation
11. Active infection or antibiotic therapy
12. Hospitalization in the last month

Study Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: (1) S-equol, (2) Placebo

This is a randomized, placebo-controlled, crossover study. Participants in one arm will receive S-equol (one visit) and then placebo (the other visit).

experimental: (1) Placebo, (2) S-equol

This is a randomized, placebo-controlled, crossover study. Participants in one arm will receive placebo (one visit) and then S-equl (the other visit).

Interventions

S-equol

Oral supplementation of S-equol

Placebo

Oral supplementation of placebo

Primary outcome measure

  • Change in Brachial Artery Flow-Mediated Dilation [ Time Frame: Baseline; 1-hour, 2-hours, and 3-hours post ingestion ]

Central Contacts and Locations

Central contacts

Ester Oh

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

Emily Andrews

303-724-7790taylor.struemph@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Ester S Oh

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

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Keywords

  • S-equol
  • Chronic Kidney Disease
  • Vascular Function
  • Women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.