Actively Recruiting
Acute Equol Supplementation and Vascular Function in Postmenopausal Women With and Without CKD
Led by University of Colorado, Denver · Updated on 2025-09-30
38
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cardiovascular disease risk is significantly higher in patients with chronic kidney disease (CKD), particularly in women who often face menstrual disturbances related to CKD. These issues may worsen vascular function and increase cardiovascular risk. However, most research has focused on men, leaving a gap in understanding women's vascular health in CKD. This trial aims to study the acute effects of oral equol supplementation on vascular function in postmenopausal women with and without CKD, addressing a high research priority to find therapies that improve vascular health and reduce cardiovascular risk in this population. Participants will receive oral supplementation with either S-equol or a placebo in a randomized, double-blind, placebo-controlled, crossover design. Each participant will undergo two visits, receiving S-equol in one and placebo in the other, with effects measured at 1, 2, and 3 hours post-ingestion. The study focuses on women aged 50 to 69 who are postmenopausal, including those with stage 3-4 CKD and healthy women without CKD. The trial will assess vascular function indicators such as brachial artery flow-mediated dilation and carotid compliance. During the study, participants will have vascular function measured at baseline and multiple points after supplementation. Blood tests will evaluate oxidative stress and inflammation markers, as well as S-equol concentrations. Researchers will monitor safety and collect data on vascular responses to determine the acute impact of equol. Participation includes two visits and active monitoring of vascular and biochemical markers to inform future studies on long-term equol effects in this population.
CONDITIONS
Brief Title
Acute Equol Supplementation and Vascular Function in Women With and Without CKD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women aged 50 to 69 years
- Women with stage 3-4 CKD (eGFR 15-59 ml/min/1.73m2) as determined by CKD-EPI 2021 equation
- Healthy women without CKD (eGFR >60 ml/min/1.73m2) free from hypertension, kidney disease, cardiovascular disease, diabetes, and other chronic diseases by self-report and screening
You will not qualify if you...
- Use of hormone replacement therapy within 6 months prior to enrollment
- Advanced CKD requiring dialysis
- History of kidney transplant
- Use of immunosuppressant medications unless stable for quiescent disease
- Current or recent (last 12 months) use of tobacco or nicotine
- Use of antioxidants or omega-3 fatty acids within 2 weeks prior to testing
- Marijuana use within 2 weeks prior to testing
- Consumption of soy or soy-based products 3 days prior to testing
- Uncontrolled hypertension (BP >140/90 mmHg) in CKD group
- Atrial fibrillation
- Active infection or antibiotic therapy
- Hospitalization within the last month
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.
Duration - Each treatment period involves assessments over a few hours post ingestion during 2 separate visits
Participants receive oral supplementation of S-equol or placebo in a randomized, crossover design to assess acute effects on vascular function and biomarkers.
2 in-person visits for supplementation and assessments, spaced apart for crossover
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
E
Emily Andrews
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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