Equol and Vascular Function in Women With Chronic Kidney Disease

NCT07194590 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-0095
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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

Keywords

S-equol; Randomized Controlled Trial; Chronic Kidney Disease; Women's Health; Vascular Function

Outcome Measures

Primary Outcomes (1)

• Brachial Artery Flow-Mediated Dilation (FMDBA)

  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.

  Baseline, 12 weeksv

Secondary Outcomes (2)

• Carotid-Femoral Pulse Wave Velocity (CFPWV)

  Baseline, 12 weeks

• Casual blood pressure

  Baseline, 12 weeks

Other Outcomes (13)

• Carotid artery compliance

  Baseline, 12 weeks

• Beta-stiffness index

  Baseline, 12 weeks

• 24-Hour Ambulatory Systolic Blood Pressure

  Baseline, 12 weeks

Study Arms (2)

Equol

EXPERIMENTAL

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

Drug: Equol

Placebo

PLACEBO COMPARATOR

This group will receive 2 placebo capsules per day.

Drug: Placebo

Interventions

Equol DRUG

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

Also known as: Equelle

Equol

Placebo DRUG

This group will receive 2 placebo capsules per day.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Equol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Ester Oh, PhD

CONTACT

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

Emily Andrews

CONTACT

303-724-7790

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).