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

RecruitingPhase 2Ages 50 Years - 69 YearsFemaleUniversity of Colorado, Denver
NCT06128278 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • S-equol
  • Placebo
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Where

1 site
University of Colorado Anschutz Medical Campus
Aurora, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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