Genistein, Equol, Cognitive Function and Mood: Acute. (GECFAMa)

NCT07742514 | Completed

• 1 other identifier: 2024-193-CW
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Isoflavones (ISF) are naturally occurring compounds that can provide protective benefits for certain domains of cognitive function. Studies on the prevalence of cognitive decline and cancers in the Asian diet-eating areas of the world have investigated the effects of the ISFs and how they affect our bodies and brains. Previous literature has shown that ISFs are capable of binding oestrogen receptors in our brains that provide protection in terms of antioxidation, anti-inflammatory and promoting the growth and interaction of our brain cells. Genistein is an important SIF having been shown to provide a strong protective response in our brains and other aspects of healthcare; Equol is a metabolite of SIFs and is thought to provide a similar (or stronger) response than Genistein due to its receptor binding strength. Unfortunately, not everyone is capable of digesting Equol from other Isoflavones (Daidzein) and therefore supplementing this directly could provide neurological benefits at a similar level, if not stronger than, Genistein. This acute study will aim to evaluate the efficacies of two ISFs (Genistein and Equol) versus a control group, in an immediately post-prandial timeframe. SIF are "Generally Recognised As Safe" ("GRAS") molecules by the United States of America's classification regulatory commission the Federal Drug Administration as well as deemed "Safe" by the European Food Safety Authority (EFSA). Participant will be required to undertake 2 one hour-long sessions. Interventions will be taken once after the baseline task battery is completed.

Conditions

Cognition; Mood

Keywords

Isoflavone; Cognitive Function; Memory; Genistein; Equol; Speed of processing; Executive Function; Acute; Post-prandial

Outcome Measures

Primary Outcomes (4)

• Post-prandial effect of Genistein or Equol versus placebo on verbal memory and learning

  Rey auditory verbal learning task: Immediate Recall Total Acquisition Final Acquisition Delayed Recall Hits Recognition Score

  4 hours

• Post-prandial effect of Genistein or Equol versus placebo on spatial working memory

  Corsi Block-Tapping Task: Correct Blocks Correct Sequences Reaction Time Initial Reaction Time

  4 hours

• Post-prandial effect of Genistein or Equol versus placebo on executive function (set-switching and cognitive flexibility)

  Task-Switching Task: Accuracy Switch Cost Reaction Time

  4 hours

• Post-prandial effect of Genistein or Equol versus placebo on speed of processing and executive function

  Trail-Making Test: Time to complete Part A Time to complete Part B B-A = Difference Score B/A = Ratio Score

  4 hours

Secondary Outcomes (1)

• Post-prandial effect of Genistein or Equol versus placebo on mood items

  4 hours

Study Arms (3)

Genistein

ACTIVE COMPARATOR

Powdered genistein at 70mg (encapsulated)

Dietary Supplement: Genistein

Equol

EXPERIMENTAL

Powdered equol at 70mg (encapsulated).

Dietary Supplement: Equol

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin powder at 70mg (encapsulated).

Dietary Supplement: Maltodextrin (Placebo)

Interventions

Genistein DIETARY_SUPPLEMENT

Genistein is a neuroprotective Isoflavone commonly found in Glycine Max (Soy).

Also known as: 4',5,7-Trihydroxyisoflavone,5,7-Dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one

Genistein

Equol DIETARY_SUPPLEMENT

Equol is a metabolite of the Isoflavone Daidzein, metabolised in roughly 10-20% of the western population.

Also known as: (3S)-Isoflavan-4,7'-diol,(3S)-3-(4-Hydroxyphenyl)-3,4-dihydro-2H-1-benzopyran-7-ol,4',7-Isoflavandiol

Equol

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

Maltodextrin is the placebo control used in this study. A non-neuroactive starch derived polysaccharide .

Maltodextrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Not currently undertaking medications including but not limited to Hormone Replacement Therapy
• Generally Healthy

You may not qualify if:

• Participant (female) has not menstruated in \>12 months (post-menopausal).
• Allergy to soy

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

School of Psychology and Clinical Languages, University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

MeSH Terms

Interventions

Genistein; Equol; maltodextrin

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Claire Williams, PhD

  University of Reading

  STUDY CHAIR

• Daniel Lamport, PhD

  University of Reading

  STUDY CHAIR

• Luke R Till, MSc

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigator masked from intervention group by third-party and participant blinded to intervention composition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Tri-arm - Genistein, Equol, Placebo (Maltodextrin) Acute investigation and comparison of intervention (70mg/daily)

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 3, 2026
• Study Start: November 14, 2024
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: August 3, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available upon study end (August 2025, anticipated)
• Access Criteria: Relevant researcher.

Locations

GB (1)