NCT06128278 Acute Equol Supplementation and Vascular Function in Women With and Without CKD
| NCT ID | NCT06128278 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2023-03-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2023-03-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06128278 clinical trial?
This trial is open to female participants only, aged 50 Years or older, up to 69 Years, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06128278 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06128278 currently recruiting?
Yes, NCT06128278 is actively recruiting participants. Contact the research team at ester.oh@cuanschutz.edu for enrollment information.
Where is the NCT06128278 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06128278 clinical trial?
NCT06128278 is sponsored by University of Colorado, Denver. The trial plans to enroll 38 participants.
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