Acute Equol Supplementation and Vascular Function in Women With and Without CKD
Study Details
Study Description
Brief Summary
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 goal of the proposed project is to determine the acute effect (1 hour after ingestion) of oral equol supplementation on vascular function in postmenopausal women with and without CKD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: (1) S-equol, (2) Placebo
|
Drug: S-equol
Oral supplementation of S-equol
|
| Experimental: (1) Placebo, (2) S-equol
|
Drug: S-equol
Oral supplementation of S-equol
|
Outcome Measures
Primary Outcome Measures
- Change in Brachial Artery Flow-Mediated Dilation [Baseline; 1 hour post ingestion]
Flow-mediated dilation of the brachial artery will be performed using ultrasonography and analyzed with a commercially available software package as percent change in diameter from baseline following reactive hyperemia.
Secondary Outcome Measures
- Change in Carotid Femoral Pulse Wave Velocity [Baseline; 1 hour post ingestion]
A transcutaneous custom tonometer [Noninvasive Hemodynamics Workstation (NIHem), Cardiovascular Engineering Inc.] will be used to non-invasively assess carotid femoral pulse wave velocity.
- Change in oxidative stress markers [Baseline; 1 hour post ingestion]
8-isoprostane
- Change in inflammation markers [Baseline; 1 hour post ingestion]
interleukin-6, tumor necrosis factor-α
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Postmenopausal (50-69 y) women
-
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
-
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:
-
Use of HRT or has used HRT for <6 months prior to enrollment
-
Advanced CKD requiring dialysis
-
History of kidney transplant
-
Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease)
-
Current tobacco or nicotine use or history of use in the last 12 months
-
Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
-
Marijuana use within 2 weeks prior to testing
-
Consumption of soy and soy-based products 3 days prior to testing
-
Uncontrolled hypertension in CKD group (BP>140/90 mmHg)
-
Atrial fibrillation
-
Active infection or antibiotic therapy
-
Hospitalization in the last month
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Anschutz Medical Campus | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-0070