Acute Equol Supplementation and Vascular Function in Women With and Without CKD

NCT06128278 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-0070
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Brachial Artery Flow-Mediated Dilation

  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; 1-hour, 2-hours, and 3-hours post ingestion

Secondary Outcomes (4)

• Change in Carotid Femoral Pulse Wave Velocity

  Baseline; 2-hour post ingestion

• Change in oxidative stress markers

  Baseline; 1-hour, 2-hours, and 3-hours post ingestion

• Change in inflammation markers

  Baseline; 1-hour, 2-hours, and 3-hours post ingestion

• Change in S-equol concentrations

  Baseline; 1-hour, 2-hours, and 3-hours post ingestion

Study Arms (2)

(1) S-equol, (2) Placebo

EXPERIMENTAL

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

Drug: S-equol; Other: Placebo

(1) Placebo, (2) S-equol

EXPERIMENTAL

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

Drug: S-equol; Other: Placebo

Interventions

S-equol DRUG

Oral supplementation of S-equol

(1) Placebo, (2) S-equol; (1) S-equol, (2) Placebo

Placebo OTHER

Oral supplementation of placebo

(1) Placebo, (2) S-equol; (1) S-equol, (2) Placebo

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)
• Current tobacco or nicotine use or history of use in the last 12 months
• Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
• Marijuana use within 2 weeks prior to testing
• Consumption of soy and soy-based products 3 days prior to testing
• Uncontrolled hypertension in CKD group (BP\>140/90 mmHg)
• Atrial fibrillation
• Active infection or antibiotic therapy
• Hospitalization in the last month

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Heart Association: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

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

CONTACT

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

Emily Andrews

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: March 7, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 30, 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).

Locations

US (1)