Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
74 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for postmenopausal women aged 50 and older with chronic kidney disease (CKD) stages 3 or 4. Participants will take equol supplements for 12 weeks to see how it affects their vascular function.
I have not had a weight change of more than 2 kg in the last 3 months
I can give informed consent
You may not be able to join if
I require chronic dialysis for my kidney disease
I have uncontrolled high blood pressure
I am using hormone replacement therapy
I have an allergy or intolerance to soy
My liver function tests are too high
I have a history of breast cancer
I have a significant health condition with a life expectancy of less than 1 year
I use tobacco or nicotine
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.
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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 effect of 12 weeks of oral equol supplementation on vascular function in postmenopausal women with CKD.
Trial Locations
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Eligibility Criteria
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 Fre…
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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