No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 69
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
38 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for postmenopausal women with and without chronic kidney disease (CKD) to see how equol affects blood vessel function. Participants will take equol and attend follow-up assessments one to three hours later.
Are You a Good Fit for This Trial?
Rules you outUncontrolled hypertensionAtrial fibrillationActive infectionRecent hospitalization
You may be able to join if
I am a postmenopausal woman aged 50 to 69.
I have CKD stage 3 or 4.
I do not have CKD and am healthy with no chronic diseases.
You may not be able to join if
I have used hormone replacement therapy in the last 6 months.
I am on dialysis for advanced CKD.
I have had a kidney transplant.
I take immunosuppressant medications.
I currently use tobacco or nicotine.
I have taken antioxidants or omega-3 fatty acids in the last 2 weeks.
I have used marijuana in the last 2 weeks.
I have consumed soy products in the last 3 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Estab…
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 vascular function in postmenopausal women with and without CKD.
Trial Locations
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Eligibility Criteria
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, …
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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