Genistein, Equol, Cognitive Function and Mood: Twelve-week. (GECFAMc)

NCT07742501 | Completed

• 1 other identifier: 2024-192-CW
• Study Type: interventional
• Target: 51
• 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 human bodies and brains. Previous literature has shown that ISFs are capable of activating oestrogen receptors in brains that provide protection in terms of long-term potentiation as well antioxidation, anti-inflammatory and promoting the growth and interaction of neurons (e.g., BDNF upregulation). Genistein is a bioactive ISF having been shown to provide a strong protective response in our brains and other aspects of healthcare; Equol is a metabolite of Daidzein and is thought to provide a similar (or stronger) response than Genistein due to its receptor binding strength. 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 twelve-week three-arm study will aim to evaluate the efficacies of two ISFs (Genistein and Equol) versus a control group. ISF 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). Participants will be required to undertake 4 one-hour-long sessions. Interventions will be taken once daily. This investigative team hypothesise that both ISFs will elicit significant positive changes in cognitive functions, specifically to spatial/verbal working memory, executive function, and speed of processing and measures of mood with a variation in effect due to age likely, the lacking restriction for age will allow for this as a covariate dependent on recruitment outcome.

Conditions

Cognition; Mood

Keywords

Isoflavone; Cognitive Function; Memory; Genistein; Equol; Speed of Processing; Executive Function; Chronic; Mood

Outcome Measures

Primary Outcomes (4)

• Chronic effect of Genistein or Equol versus placebo on verbal learning and memory

  Rey Auditory Verbal Learning Task: Word span Total acquisition Final acquisition Amount learned Proactive interference Retroactive interference Delayed recall Hits False positives Primacy effect Recognition score Non-credible score

  12 weeks

• Chronic effect of Genistein or Equol versus placebo on spatial working memory

  Corsi Block-Tapping Task: Block span Correct blocks Correct sequence Initial reaction time Reaction time

  12 weeks

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

  Task-switching Task: Accuracy Switch cost Reaction time Reaction time - repeat trials Reaction time - switch trials Reaction time - High/Low Reaction time - Odd/Even Non-error Reaction time Post-error Reaction time Post-error Slowing

  12 weeks

• Chronic effect of Genistein or Equol versus placebo on speed of processing and executive functioning

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

  12 weeks.

Secondary Outcomes (1)

• Chronic effect of Genistein or Equol versus placebo on mood items

  12 weeks.

Study Arms (3)

Genistein

ACTIVE COMPARATOR

Powdered genistein at 70mg/daily encapsulated for 12-weeks.

Dietary Supplement: Genistein

Equol

EXPERIMENTAL

Equol at 70mg/daily encapsulated for 12-weeks.

Dietary Supplement: Equol

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin at 70mg/daily encapsulated for 12-weeks.

Dietary Supplement: Maltodextrin

Interventions

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

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

Maltodextrin 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

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Equol; Genistein; 4'-methoxy-3',5,7-trihydroxyisoflavone; maltodextrin

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrans; Heterocyclic Compounds, 1-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) 12-week Intervention (70mg/daily)

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 3, 2026
• Study Start: November 1, 2024
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: August 3, 2026

Record last verified: 2024-11

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)