RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-07
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06128278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 69 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Postmenopausal (50-69 y) women
  2. 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. 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).
  1. 1. Use of HRT or has used HRT for \<6 months prior to enrollment
  2. 2. Advanced CKD requiring dialysis
  3. 3. History of kidney transplant
  4. 4. Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease)
  5. 5. Current tobacco or nicotine use or history of use in the last 12 months
  6. 6. Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
  7. 7. Marijuana use within 2 weeks prior to testing
  8. 8. Consumption of soy and soy-based products 3 days prior to testing
  9. 9. Uncontrolled hypertension in CKD group (BP\>140/90 mmHg)
  10. 10. Atrial fibrillation
  11. 11. Active infection or antibiotic therapy
  12. 12. Hospitalization in the last month

Contacts and Locations

Study Contact

Ester Oh
CONTACT
303-724-3765
ester.oh@cuanschutz.edu
Taylor Struemph
CONTACT
303-724-7792
taylor.struemph@cuanschutz.edu

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-07
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2023-03-07
Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Diseases