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Clinical Trial Details

Trial ID: L0068
Source ID: NCT06128278
Associated Drug: S-Equol
Title: Acute Equol Supplementation and Vascular Function in Women With and Without CKD
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: S-equol
Outcome Measures: 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, 2-hours, and 3-hours 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; 2-hour post ingestion|Change in oxidative stress markers, 8-isoprostane, Baseline; 1-hour, 2-hours, and 3-hours post ingestion|Change in inflammation markers, interleukin-6, tumor necrosis factor-α, Baseline; 1-hour, 2-hours, and 3-hours post ingestion|Change in S-equol concentrations, Plasma S-equol levels, Baseline; 1-hour, 2-hours, and 3-hours post ingestion
Sponsor/Collaborators: Sponsor: University of Colorado, Denver
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 38
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-07
Completion Date: 2025-03-31
Results First Posted:
Last Update Posted: 2024-08-23
Locations: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT06128278