CognitionGECFAMcNCT07742501
Genistein, Equol, Cognitive Function and Mood: Twelve-week. (GECFAMc)
A study testing Equol, Genistein and Maltodextrin in people with Cognition and Mood, run by University of Reading at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Equol, Genistein and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2024to 14 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not currently undertaking medications including but not limited to Hormone Replacement Therapy
- Generally Healthy
Who cannot join
- Participant (female) has not menstruated in >12 months (post-menopausal).
- Allergy to soy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Psychology and Clinical Languages, University of Reading
Reading, Berkshire, RG6 6AL
About this study
Official title: Investigation of Genistein and Equol's Effects on Cognitive Function Domains and Mood Measures in a Twelve-week Long Placebo-controlled, Double-blind Clinical Trial
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.
Read more
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.
Read the detailed description
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 the researchers will check exclusion/inclusion criteria have been met; participants will be quasi-randomly allocated to intervention based on age and sex, 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. Return appointments will be made for their study days 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 first testing day (baseline), participants will attend the laboratory after consuming their standard breakfast, but to refrain from consuming any caffeine-containing products (researchers 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 some mood questionnaire.
On completion of the battery, the participants will be supplied with their allocation of intervention and asked to consume one capsule every day for a 12-week period.
After 6 and 12 weeks of consuming the intervention, subjects will return to the lab for their 2nd \& 3rd study days. On these test days, subjects will be asked not to consume their intervention until after testing has occurred. Here the researchers will follow the same protocol as for the 1st study day, where a single set of cognitive tests and mood measures will be completed. At the end of the trial, pots of pills will be returned to researchers and compared against the expected number of remaining pills to measure adherence.
The task battery is composed of cognitive tests and measures of mood, which previous data have shown to be sensitive to nutritional interventions chronically. More generally, the cognitive tests are categorised into one of three key cognitive domains, speed of processing/memory/executive function whilst changes in mood will be measured using the PANAS.
- Being tested
- Equol, Genistein, Maltodextrin
- Keywords
- Isoflavone, Cognitive Function, Memory, Genistein, Equol, Speed of Processing, Executive Function, Chronic, Mood
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EquolDietary supplement
Also called (3S)-Isoflavan-4,7'-diol, (3S)-3-(4-Hydroxyphenyl)-3,4-dihydro-2H-1-benzopyran-7-ol, 4',7-Isoflavandiol
Equol is a metabolite of the Isoflavone Daidzein, metabolised in roughly 10-20% of the western population.
GenisteinDietary supplement
Also called 4',5,7-Trihydroxyisoflavone, 5,7-Dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one
Genistein is a neuroprotective Isoflavone commonly found in Glycine Max (Soy).
MaltodextrinDietary supplement
Maltodextrin is the placebo control used in this study. A non-neuroactive starch derived polysaccharide .
| Study group | Role | What they receive |
|---|---|---|
| Genistein | Active comparator | Powdered genistein at 70mg/daily encapsulated for 12-weeks. Receives: Dietary Supplement: Genistein |
| Equol | Experimental | Equol at 70mg/daily encapsulated for 12-weeks. Receives: Dietary Supplement: Equol |
| Maltodextrin | Placebo comparator | Maltodextrin at 70mg/daily encapsulated for 12-weeks. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks.
Secondary outcomes (1)
Chronic effect of Genistein or Equol versus placebo on mood items
Positive and Negative Affect Schedule:
Positive Affect Schedule Negative Affect Schedule
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Nov 2024
- Primary completion14 Oct 2025
- Study completion14 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tri-arm - Genistein, Equol, Placebo (Maltodextrin) 12-week Intervention (70mg/daily)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Claire Williams, University of Reading
- Investigators
- Claire Williams, PhD, Study chair, University of ReadingDaniel Lamport, PhD, Study chair, University of ReadingLuke R Till, MSc, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742501
- Sponsor's protocol ID
- 2024-192-CW
- Acronym
- GECFAMc
- Status last verified
- Nov 2024
- First submitted
- 23 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifying information is to be restricted to investigators and deleted persuant to GDPR laws. Data to be shared includes demographic information and test outcomes (Cognitive and mood measures).
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Genistein and Equol's Effects on Cognitive Function Domains and Mood Measures in a Twelve-week Long Placebo-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07742501
- Acronym / sponsor ID
- GECFAMc / 2024-192-CW
- Keywords
- Isoflavone, Cognitive Function, Memory, Genistein, Equol, Speed of Processing, Executive Function, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 14 Oct 2025 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 the researchers will check exclusion/inclusion criteria have been met; participants will be quasi-randomly allocated to intervention based on age and sex, 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. Return appointments will be made for their study days 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 first testing day (baseline), participants will attend the laboratory after consuming their standard breakfast, but to refrain from consuming any caffeine-containing products (researchers 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 some mood questionnaire.
On completion of the battery, the participants will be supplied with their allocation of intervention and asked to consume one capsule every day for a 12-week period.
After 6 and 12 weeks of consuming the intervention, subjects will return to the lab for their 2nd \& 3rd study days. On these test days, subjects will be asked not to consume their intervention until after testing has occurred. Here the researchers will follow the same protocol as for the 1st study day, where a single set of cognitive tests and mood measures will be completed. At the end of the trial, pots of pills will be returned to researchers and compared against the expected number of remaining pills to measure adherence.
The task battery is composed of cognitive tests and measures of mood, which previous data have shown to be sensitive to nutritional interventions chronically. More generally, the cognitive tests are categorised into one of three key cognitive domains, speed of processing/memory/executive function whilst changes in mood will be measured using the PANAS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Tri-arm - Genistein, Equol, Placebo (Maltodextrin) 12-week Intervention (70mg/daily)
| Arm | Type | Receives |
|---|---|---|
| Genistein | Active comparator | Dietary Supplement: GenisteinPowdered genistein at 70mg/daily encapsulated for 12-weeks. |
| Equol | Experimental | Dietary Supplement: EquolEquol at 70mg/daily encapsulated for 12-weeks. |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin at 70mg/daily encapsulated for 12-weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Not currently undertaking medications including but not limited to Hormone Replacement Therapy
- Generally Healthy
Key exclusion criteria (2 listed)
- Participant (female) has not menstruated in >12 months (post-menopausal).
- Allergy to soy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EquolAlso: (3S)-Isoflavan-4,7'-diol, (3S)-3-(4-Hydroxyphenyl)-3,4-dihydro-2H-1-benzopyran-7-ol, 4',7-IsoflavandiolEquol is a metabolite of the Isoflavone Daidzein, metabolised in roughly 10-20% of the western population. | Dietary supplement | Equol |
| GenisteinAlso: 4',5,7-Trihydroxyisoflavone, 5,7-Dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-oneGenistein is a neuroprotective Isoflavone commonly found in Glycine Max (Soy). | Dietary supplement | Genistein |
| MaltodextrinMaltodextrin is the placebo control used in this study. A non-neuroactive starch derived polysaccharide . | Dietary supplement | Maltodextrin |
Primary outcome
Chronic effect of Genistein or Equol versus placebo on verbal learning and memory
Time frame: 12 weeks
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
Chronic effect of Genistein or Equol versus placebo on spatial working memory
Time frame: 12 weeks
Corsi Block-Tapping Task: Block span Correct blocks Correct sequence Initial reaction time Reaction time
Chronic effect of Genistein or Equol versus placebo on executive function (set-switching and cognitive flexibility
Time frame: 12 weeks
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
Chronic effect of Genistein or Equol versus placebo on speed of processing and executive functioning
Time frame: 12 weeks.
Trail-Making Test: Time to complete Part A Time to complete Part B B-A = Difference Score B/A = Ratio Score
1 secondary outcome
Chronic effect of Genistein or Equol versus placebo on mood items
Time frame: 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. Identifying information is to be restricted to investigators and deleted persuant to GDPR laws. Data to be shared includes demographic information and test outcomes (Cognitive and mood measures).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Williams, PhD study chair
University of Reading
Daniel Lamport, PhD study chair
University of Reading
Luke R Till, MSc principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equol, Genistein and Maltodextrin in people with Cognition and Mood, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic effect of Genistein or Equol versus placebo on verbal learning and memory (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.