Actively Recruiting

Phase 2
Age: 50Years - 69Years
FEMALE
Healthy Volunteers
NCT06128278

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

Led by University of Colorado, Denver · Updated on 2025-09-30

38

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

A

American Heart Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years - 69Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women aged 50 to 69 years
  • Women with stage 3-4 CKD (eGFR 15-59 ml/min/1.73m2) as determined by CKD-EPI 2021 equation
  • Women without CKD (eGFR >60 ml/min/1.73m2) who are healthy without hypertension, kidney disease, cardiovascular disease, diabetes, or other chronic diseases
Not Eligible

You will not qualify if you...

  • Use of hormone replacement therapy currently or within 6 months prior to enrollment
  • Advanced CKD requiring dialysis
  • History of kidney transplant
  • Use of immunosuppressant medications unless on stable dosage for quiescent disease
  • Current or recent (last 12 months) tobacco or nicotine use
  • Use of antioxidants or omega-3 supplements within 2 weeks prior to testing
  • Marijuana use within 2 weeks prior to testing
  • Consumption of soy or soy-based products within 3 days prior to testing
  • Uncontrolled hypertension in CKD group (blood pressure >140/90 mmHg)
  • Atrial fibrillation
  • Active infection or receiving antibiotic therapy
  • Hospitalization within the last month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

E

Ester Oh

CONTACT

E

Emily Andrews

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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