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 |
Trial Parameters
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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 mm
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