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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06128278
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Kidney Diseases
  • Vascular Function
  • Women

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 69 Years
Healthy Volunteers
Accepted

Interventions

  • S-equol — DRUG
    Oral supplementation of S-equol
  • Placebo — OTHER
    Oral supplementation of placebo

Study Details

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.

Key Dates

Start date
Mar 7, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: (1) S-equol, (2) Placebo
    This is a randomized, placebo-controlled, crossover study. Participants in one arm will receive S-equol (one visit) and then placebo (the other visit).
  • Experimental: (1) Placebo, (2) S-equol
    This is a randomized, placebo-controlled, crossover study. Participants in one arm will receive placebo (one visit) and then S-equl (the other visit).

Primary Outcome Measure

Change in Brachial Artery Flow-Mediated Dilation [ Time Frame: Baseline; 1-hour, 2-hours, and 3-hours post ingestion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Ester S Oh
[email protected]
303-724-3765

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By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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