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Equol and Vascular Function in Women With Chronic Kidney Disease

RecruitingPhase 2Ages 50 Years - anyFemaleUniversity of Colorado, Denver
NCT07194590 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 effect of 12 weeks of oral equol supplementation on vascular function in postmenopausal wome

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📋 Eligibility rules (as published)
Inclusion Criteria: * Postmenopausal women * Aged ≥50 years * CKD stage 3 or 4 (eGFR with the CKD-EPI 2021 race-free equation: 15-59 mL/min/1.73m2; stable renal function in the past 3 months) * Low habitual intake of soy (soy-related food intake \< 2 times per week assessed by Soy-Specific Food Frequency Questionnaire) * Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study * Ability to provide informed consent. Exclusion Criteria: * Patients with advanced CKD requiring chronic dialysis * Uncontrolled hypertension in CKD group (BP \>140/90 mmHg) * Use of any hormone replacement therapy * Allergy and/or intolerance to soy or soy-based products * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin values 2X upper limit of normal range (upper limit of normal range AST: 117 U/L; ALT: 52 U/L; total bilirubin: 1.3 mg/dL) * History of breast cancer * Significant co-morbid conditions with a life expectancy of \< 1 year * Current tobacco or nicotine use or history of use in the last 12 months * History of kidney transplant * History of severe congestive heart failure (i.e., ejection fraction \<35%) * History of hospitalization within the last month * Immunosuppressant agents taken in the past 12 months * Known malignancy
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What it tests

  • 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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