NCT07194590RecruitingPhase 2
Equol and Vascular Function in Women With Chronic Kidney Disease
Equol Supplementation for Improving Vascular Function in Postmenopausal Women With CKD
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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 women with CKD.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 12 Sept 2025
- Start date
- 19 Feb 2026
- Primary completion date
- 30 Nov 2030
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Chronic kidney disease
- NCT number
- NCT07194590
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 74
- From 19 Feb 2026 to the primary completion date, 30 Nov 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any hormone replacement therapy
Other illness
- Uncontrolled hypertension in CKD group (BP \>140/90 mmHg)
- Allergy and/or intolerance to soy or soy-based products
- 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 hospitalization within the last month
- Known malignancy
Lab values
- 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 severe congestive heart failure (i.e., ejection fraction \<35%)
Other
- Patients with advanced CKD requiring chronic dialysis
- Immunosuppressant agents taken in the past 12 months
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.