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Completed

NCT Number: NCT07742514

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

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.

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Key information

Conditions

Cognition Mood

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Psychology and Clinical Languages, University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

About this study

The design of this study is as a three-arm, placebo controlled, double-blind with between-groups comparison. Adult participants aged 18 years old and over will be recruited to the study from the local community (see Appendix H for recruitment poster). After demonstrating an initial interest in the study, participants will be sent the participant information sheet (Appendix A), a health and lifestyle questionnaire (Appendix C), and FFQ to assess habitual diets, supplements and medications (Appendix D). A screening interview will be used to answer the health and lifestyle questionnaire and participants who meet the screening criteria will be able to undergo a practice session where they will sign a consent form (Appendix B) and familiarise themselves with the cognitive tasks and mood questionnaires. Recruitment materials will include posting posters advertising (Appendix H) as well as posts on pertinent social media outlets (such as Reddit page r/Reading)

Following a this screening session wherein we will check exclusion/inclusion criteria have been met; participants will be randomly allocated to interventions consisting of a control group (maltodextrin), a genistein group (70mg/day) and an equol group (70mg/day). Participants will also undergo a familiarisation session with the computerised software at this screening session. Return appointments will be made for the study day and participants will be reminded of their right to withdraw from the study at any point. Helplines and web links with support and advice will be provided (Mind, Alzheimer's Society, Dementia UK) alongside advice to contact their GP should they require medical support.

On the testing day, between 7-14 days after the screening visit, participants will attend the laboratory after consuming their standard breakfast, but to refrain from consuming any caffeine-containing products (we will ask participants to consume the same breakfast on their second test day). Upon arrival at the University, participants will be asked to complete a battery of cognitive tasks and to complete the mood measure after this.

On completion of the battery, they will be supplied with their intervention capsule and asked to consume it in front of the researcher. After the two-hour break to allow for absorption and circulation, the participants will complete the task battery of cognitive and mood measures.Our task battery is composed of cognitive tests are categorised into one of three cognitive domains pertinent to neurotransmitter and oestrogen receptor functions, speed of processing/memory/executive function whilst changes in current mood state will be measured using the PANAS-Now.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Genistein

Dietary Supplement

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

Other names: 4',5,7-Trihydroxyisoflavone,5,7-Dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one

Equol

Dietary Supplement

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

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

Maltodextrin (Placebo)

Dietary Supplement

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

Primary outcomes

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

    Time frame: 4 hours

    Rey auditory verbal learning task:

    Immediate Recall Total Acquisition Final Acquisition Delayed Recall Hits Recognition Score

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

    Time frame: 4 hours

    Corsi Block-Tapping Task:

    Correct Blocks Correct Sequences Reaction Time Initial Reaction Time

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

    Time frame: 4 hours

    Task-Switching Task:

    Accuracy Switch Cost Reaction Time

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

    Time frame: 4 hours

    Trail-Making Test:

    Time to complete Part A Time to complete Part B B-A = Difference Score B/A = Ratio Score

Secondary outcomes

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

    Time frame: 4 hours

    Positive And Negative Affect Schedule - Extended (State) Form:

    General Positive Emotion Base Positive Affect General Negative Emotion Base Negative Affect

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

Investigation of Genistein and Equol's Effects on Cognitive Function Domains and Mood Measures in a Post-prandial Time-frame, Placebo-controlled and Double-blind Clinical Trial

Acronym: GECFAMa

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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