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PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition
Sponsor: Roberta Brinton
Summary
This is a proof-of-concept phase 2 clinical trial to investigate the safety and effect of the phytoestrogenic supplement PhytoSERM on regional brain metabolism by fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in peri- and postmenopausal women. The investigators hypothesize that there will be a significant difference between the PhytoSERM group and placebo group in glucose brain metabolism.
Official title: PhytoSERM Efficacy to Prevent Menopause Associated Decline in Brain Metabolism and Cognition: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial
Key Details
Gender
All
Age Range
45 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-01-10
Completion Date
2027-01-31
Last Updated
2026-03-13
Healthy Volunteers
Yes
Interventions
PhytoSERM
PhytoSERM is a dietary supplement containing equal amounts of genistein (16.7 mg ± 10%), daidzein (16.7 mg ± 10%) and S-equol (16.7 mg ± 10%).
Placebo
Placebo product with identical shape, size and color will be produced with absence of S-equol, daidzein and genistein. Ingredients include calcium carbonate, comprecel M102, croscarmellose sodium, stearic acid, Zeofree 5162, magnesium stearate, carnauba wax, coating cellulose clear (PEG), coating white (PEG), water.
Locations (2)
University of Arizona / Clinical & Translational Sciences Research Center (CATS
Tucson, Arizona, United States
The Alzheimer's Prevention Program / Weill Cornell Medicine
New York, New York, United States