Status:
RECRUITING
Acute Equol Supplementation and Vascular Function in Women With and Without CKD
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
American Heart Association
Conditions:
Chronic Kidney Diseases
Vascular Function
Eligibility:
FEMALE
50-69 years
Phase:
PHASE2
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, whi...
Detailed Description
Patients with chronic kidney disease (CKD) have a significantly higher risk of cardiovascular diseases (CVD). Indeed, CVD is the leading cause of death in these patients. A primary reason why CKD so g...
Eligibility Criteria
Inclusion
- Postmenopausal (50-69 y) women
- 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
- 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
- Use of HRT or has used HRT for \<6 months prior to enrollment
- Advanced CKD requiring dialysis
- History of kidney transplant
- Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease)
- Current tobacco or nicotine use or history of use in the last 12 months
- Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
- Marijuana use within 2 weeks prior to testing
- Consumption of soy and soy-based products 3 days prior to testing
- Uncontrolled hypertension in CKD group (BP\>140/90 mmHg)
- Atrial fibrillation
- Active infection or antibiotic therapy
- Hospitalization in the last month
Key Trial Info
Start Date :
March 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06128278
Start Date
March 7 2023
End Date
December 31 2026
Last Update
September 30 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045