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ACTIVE NOT RECRUITING
NCT05664477
PHASE2

PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition

Sponsor: Roberta Brinton

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

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%).

DRUG

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