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

Study acronym: ACE
StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv14
  2. Minor Enrollment target: 372 to 369v13
  3. Minor Enrollment target: estimated 400 to confirmed 372v12
  4. Re-verified, no change to tracked fieldsv11
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Primary completion date: Apr 2026 to Oct 31, 2026
    • Study completion date: Apr 2026 to Jan 30, 2027
    v9
  2. Minor Eligibility criteria expanded, about 7 words
    • Site details revised at 1 of 3 sites
    v8
  3. Minor Site details revised at 1 of 3 sitesv7
  4. Minor Start date changed from estimate of Jul 2023 to Jun 29, 2023v6
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    • Eligibility criteria shortened, about 1 word
    v5
  6. Notable Start date: May 2023 to Jul 2023v4
  7. Minor Start date: Apr 2023 to May 2023v3
  8. Notable Start date: Feb 28, 2023 to Apr 2023
    • Eligibility criteria expanded, about 9 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05741060
Lead Sponsor Akira Sekikawa
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)
Arterial Stiffness, White Matter Lesions, Cognitive Decline
Related terms Alzheimer Disease, Cognitive Dysfunction, Dementia
Enrollment 369 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov