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ACTIVE NOT RECRUITING
NCT05741060
PHASE2

Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers

Sponsor: Akira Sekikawa

View on ClinicalTrials.gov

Summary

The ACE Trial, funded by the National Institute on Ageing/National Institutes of Health (NIH), is a multicenter clinical trial. The ACE Trial will determine if taking the dietary supplement Equol could slow the progression of stiffening of the arteries, small blood vessel disease in the brain and memory decline. Equol is a soy-based supplement that has plant estrogen-like compounds in it. Equol is a metabolite of soy isoflavone. Our studies in Japan and other studies suggest that Equol may slow mechanisms related to memory decline. No previous studies in the United States have tested the effect of Equol on these mechanisms or memory decline. Supplementation of Equol in the ACE Trial is approved by the Food and Drug Administration (FDA). Researchers at the University of Pittsburgh, Pittsburgh, Pennsylvania, Wake Forest University, Winston-Salem, North Carolina, and Emory University, Atlanta, Georgia, are recruiting participants. The ACE Trial will ask participants to complete 7 clinic visits over a two-year period. The participants are asked to take Equol tablets daily for 24 months. Clinic procedures include Pulse Wave Velocity (to measure arterial stiffness), Magnetic Resonance Imaging (MRI) of the brain and tests of awareness and thinking.

Official title: Arterial Stiffness, Cognition and Equol

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

369

Start Date

2023-06-29

Completion Date

2027-01-30

Last Updated

2025-09-29

Healthy Volunteers

Yes

Interventions

DRUG

S-equol

Experimental drug

DRUG

Placebo

Placebo - 10 mg per day for 24 months of tablets that will be the same size/shape/color as the s-equol tablets.

Locations (3)

Emory University

Atlanta, Georgia, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States