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PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition

NCT05664477 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Menopause
  • Cognitive Change
  • Brain Disorder, Metabolic

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Cornell University

    collaborator OTHER

  • ADM Diagnostics

    collaborator UNKNOWN

  • Roberta Brinton

    lead OTHER

Principal Investigators

  • Roberta D Brinton, PhD · University of Arizona

  • Gerson D Hernandez, MD, MPH · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664477 on ClinicalTrials.gov