Acute Equol Supplementation and Vascular Function in Women With and Without CKD

Chronic Kidney Diseases Clinical Trial

Official title:

Acute Equol Supplementation and Vascular Function in Postmenopausal Women With and Without CKD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128278
• Other study ID #: 23-0070
• Status: Recruiting
• Phase: Phase 2
• Start date: March 7, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Ester Oh
• Phone: 303-724-3765
• Email: ester.oh[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• S-equol
Oral supplementation of S-equol

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brachial Artery Flow-Mediated Dilation	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.	Baseline; 1 hour post ingestion
Secondary	Change in Carotid Femoral Pulse Wave Velocity	A transcutaneous custom tonometer [Noninvasive Hemodynamics Workstation (NIHem), Cardiovascular Engineering Inc.] will be used to non-invasively assess carotid femoral pulse wave velocity.	Baseline; 1 hour post ingestion
Secondary	Change in oxidative stress markers	8-isoprostane	Baseline; 1 hour post ingestion
Secondary	Change in inflammation markers	interleukin-6, tumor necrosis factor-a	Baseline; 1 hour post ingestion