Effects of equol on vascular function in women with and without chronic kidney disease
Acute Equol Supplementation and Vascular Function in Postmenopausal Women With and Without CKD
This study is testing if taking equol can improve blood vessel health in postmenopausal women, both with and without chronic kidney disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 50 Years to 69 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06128278 on ClinicalTrials.gov |
What this trial studies
This study investigates the acute effects of oral equol supplementation on vascular function in postmenopausal women, both with and without chronic kidney disease (CKD). It aims to assess changes in vascular health, particularly focusing on endothelial function and arterial stiffness, which are critical factors in cardiovascular disease risk. The study will measure vascular responses at multiple time points after equol ingestion to determine its potential benefits for women affected by CKD. The research addresses a significant gap in understanding women's vascular health in the context of CKD, which is often overlooked in nephrology literature.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 50-69, with either stage 3-4 chronic kidney disease or healthy women without kidney disease.
Not a fit: Patients with advanced chronic kidney disease requiring dialysis or those with a history of kidney transplant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vascular health and reduced cardiovascular disease risk in postmenopausal women with chronic kidney disease.
How similar studies have performed: While there is limited research specifically on equol's effects in this population, studies on similar interventions have shown promise in improving vascular function in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Ester Oh
- Email: ester.oh@cuanschutz.edu
- Phone: 303-724-3765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.