Actively Recruiting

Phase 2
Age: 50Years - 69Years
FEMALE
Healthy Volunteers
ID06128278

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

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

38

Participants Needed

1

Research Sites

N/A

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

Cardiovascular disease risk is significantly higher in patients with chronic kidney disease (CKD), particularly in women who often face menstrual disturbances related to CKD. These issues may worsen vascular function and increase cardiovascular risk. However, most research has focused on men, leaving a gap in understanding women's vascular health in CKD. This trial aims to study the acute effects of oral equol supplementation on vascular function in postmenopausal women with and without CKD, addressing a high research priority to find therapies that improve vascular health and reduce cardiovascular risk in this population. Participants will receive oral supplementation with either S-equol or a placebo in a randomized, double-blind, placebo-controlled, crossover design. Each participant will undergo two visits, receiving S-equol in one and placebo in the other, with effects measured at 1, 2, and 3 hours post-ingestion. The study focuses on women aged 50 to 69 who are postmenopausal, including those with stage 3-4 CKD and healthy women without CKD. The trial will assess vascular function indicators such as brachial artery flow-mediated dilation and carotid compliance. During the study, participants will have vascular function measured at baseline and multiple points after supplementation. Blood tests will evaluate oxidative stress and inflammation markers, as well as S-equol concentrations. Researchers will monitor safety and collect data on vascular responses to determine the acute impact of equol. Participation includes two visits and active monitoring of vascular and biochemical markers to inform future studies on long-term equol effects in this population.

CONDITIONS

Brief 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
  • Healthy women without CKD (eGFR >60 ml/min/1.73m2) free from hypertension, kidney disease, cardiovascular disease, diabetes, and other chronic diseases by self-report and screening
Not Eligible

You will not qualify if you...

  • Use of hormone replacement therapy within 6 months prior to enrollment
  • Advanced CKD requiring dialysis
  • History of kidney transplant
  • Use of immunosuppressant medications unless stable for quiescent disease
  • Current or recent (last 12 months) use of tobacco or nicotine
  • Use of antioxidants or omega-3 fatty acids within 2 weeks prior to testing
  • Marijuana use within 2 weeks prior to testing
  • Consumption of soy or soy-based products 3 days prior to testing
  • Uncontrolled hypertension (BP >140/90 mmHg) in CKD group
  • Atrial fibrillation
  • Active infection or 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Each treatment period involves assessments over a few hours post ingestion during 2 separate visits

Participants receive oral supplementation of S-equol or placebo in a randomized, crossover design to assess acute effects on vascular function and biomarkers.

2 in-person visits for supplementation and assessments, spaced apart for crossover

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

E

Emily Andrews

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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