Actively Recruiting
Equol Supplementation to Improve Vascular Function in Postmenopausal Women With Chronic Kidney Disease
Led by University of Colorado, Denver · Updated on 2026-06-02
74
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of oral equol supplementation on vascular function in postmenopausal women with chronic kidney disease (CKD). Women with CKD face a higher risk of cardiovascular disease (CVD), partly due to vascular dysfunction and reduced protective hormones after menopause. The study addresses the gap in understanding vascular health in women with CKD, focusing on a potential new therapy to improve vascular function and reduce CVD risk. Participants are randomly assigned to one of two groups in this double-blind, placebo-controlled trial. One group receives 10 mg of equol daily (two capsules of 5 mg each) for 12 weeks, while the other group receives placebo capsules. The study tests the longer-term effects of equol supplementation on vascular health compared to placebo. During the study, participants will undergo assessments at baseline and after 12 weeks, including measurements of brachial artery flow-mediated dilation (FMDBA), carotid-femoral pulse wave velocity (CFPWV), and casual blood pressure. Researchers will monitor vascular function changes and safety throughout the trial. The total participation time spans the 12-week supplementation period with these specific vascular function evaluations.
CONDITIONS
Brief Title
Equol and Vascular Function in Women With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women
- Aged 50 years or older
- Chronic kidney disease stage 3 or 4 with stable kidney function in the past 3 months
- Low habitual intake of soy foods (less than 2 times per week)
- Stable weight in the prior 3 months (less than 2 kg change) and willingness to maintain weight during study
- Ability to provide informed consent
You will not qualify if you...
- Advanced chronic kidney disease requiring chronic dialysis
- Uncontrolled high blood pressure (greater than 140/90 mmHg)
- Current use of hormone replacement therapy
- Allergy or intolerance to soy or soy-based products
- Elevated liver enzymes or bilirubin above twice the normal limit
- History of breast cancer
- Severe co-morbid conditions with life expectancy under 1 year
- Current or recent (past 12 months) tobacco or nicotine use
- History of kidney transplant
- Severe congestive heart failure (ejection fraction under 35%)
- Hospitalization within the last month
- Use of immunosuppressant agents in the past 12 months
- Known malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take oral equol or placebo capsules daily to assess effects on vascular function.
Baseline visit and 1 follow-up visit at 12 weeks
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
E
Ester Oh, PhD
E
Emily Andrews
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here