PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition

What this trial studies

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 in scope

• Menopause
• Cognitive Change
• Brain Disorder, Metabolic

Interventions

• PhytoSERM (Dietary Supplement) — 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 (Drug) — 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…

Who can join

All sexes · Ages 45 Years to 60 Years · Accepts healthy volunteers.

Inclusion criteria

• Peri- or postmenopausal women with the latter defined as last menstrual period (LMP) completed ≥ 60 days and ≤ 4 years, per the Stages of Reproductive Aging Workshop (STRAW) criteria.
• Age 45-60 years.
• Presence of hot flashes ≥ 7 per day.
• In good general health as evidenced by medical history.
• Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be not clinically significant by the investigator.
• No medical contraindications to study participation.
• Stable medications for 4 weeks prior to the baseline visits.
• Provision of signed and dated informed consent form.

Exclusion criteria

• Known allergies to isoflavones or soy-based products.
• Evidence of cognitive impairment on the Mini-Mental State Examination (total score \< 27).
• Pregnancy
• Use of estrogen or progestin compounds within 8 weeks of baseline.
• Use of investigational agent within 12 weeks of baseline.
• Concurrent neurologic, systemic, or psychiatric disease that would influence cognition or ability to provide informed consent and to participate.
• Known or suspected estrogen-dependent neoplasia, active neoplastic disease, history of breast cancer, or at risk of developing breast cancer, endometrial hyperplasia.
• History of epilepsy, focal brain lesion, head injury with loss of consciousness or Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2024-01-10
• Primary completion: 2027-01-31
• Last update posted: 2026-03-13
• First posted: 2022-12-23

Sponsor & contact

Lead sponsor: Roberta Brinton (Other)

Collaborators: National Institute on Aging (NIA), Cornell University, ADM Diagnostics

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Standardized uptake value ratio (SUVR) by 18F-FDG PET (Baseline to 24 weeks)
  Regional brain glucose metabolism SUVR

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.