Effect of Oral Equol on Vascular Health in Postmenopausal Women With and Without Chronic Kidney Disease A Randomized, Placebo-Controlled, Crossover Phase 2 Study

What this Trial Is About

Cardiovascular disease risk is significantly higher in patients with chronic kidney disease CKD, particularly in women who often face menstrual disturbances related to CKD. These issues may worsen vascular function and increase cardiovascular risk. However, most research has focused on men, leaving a gap in understanding womens vascular health in CKD. This trial aims to study the acute effects of oral equol supplementation on vascular function in postmenopausal women with and without CKD, addressing a high research priority to find therapies that improve vascular health and reduce cardiovascular risk in this population. Participants will receive oral supplementation with either S-equol or a placebo in a randomized, double-blind, placebo-controlled, crossover design. Each participant will undergo two visits, receiving S-equol in one and placebo in the other, with effects measured at 1, 2, and 3 hours post-ingestion. The study focuses on women aged 50 to 69 who are postmenopausal, including those with stage 3-4 CKD and healthy women without CKD. The trial will assess vascular function indicators such as brachial artery flow-mediated dilation and carotid compliance. During the study, participants will have vascular function measured at baseline and multiple points after supplementation. Blood tests will evaluate oxidative stress and inflammation markers, as well as S-equol concentrations. Researchers will monitor safety and collect data on vascular responses to determine the acute impact of equol. Participation includes two visits and active monitoring of vascular and biochemical markers to inform future studies on long-term equol effects in this population.

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