Cognitive ChangeOYSCOGNCT06846827
Cognitive, Mood, Anti-Inflammatory and Metabolic Effects of Chronic Oyster Mushroom Intervention in Older Adults
A study testing Oyster mushroom and Maltodextrin in people with Cognitive Change and Mood, run by University of Reading at 1 site in United Kingdom.
Trial summary
The Pleurotus oyster species is a common edible mushroom rich in phytochemicals such as proteins, phenolic compounds, dietary fibre and is also particularly rich in ergothioneine, a bioactive known for its neurocognitive benefits. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Mood, Metabolism
- What is being tested?
- Oyster mushroom and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2023to 3 Jul 2024
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 60-80 years old
- Have normal vision and hearing
- Have a Body mass index (BMI<=30)
- Have healthy status
Who cannot join
- Smokers
- Vegans/vegetarians
- Being diagnosed with a psychiatric/neurological condition (eg., stroke, schizophrenia, depression, cognitive impairement, dementia)
- Being diagnosed with a learning/behavioural disorder (e.g. dyslexia, autism, ADHD)
- Being diagnosed with a metabolic disease (eg., type I/II diabetes and cardiovascular disease), or suffer from unmediated hypertension or thrombosis related disorders, or suffer from cancer, kidney or liver disease
- Being anaemic
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- Taking disease medication such as anticoagulants, antiplatelet medication, dementia medication, antidepressants, antiepileptic medication, thyroid medication
- Refusing to stop taking vitamin supplements (including prebiotics/probiotics) during the 12-week testing period
- Have food allergies
- Having a difficulty in completing computer-based cognitive tasks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial to Investigate the Cognitive, Mood, Anti-inflammatory and Metabolic Effects of Chronic Oyster Mushroom Intervention in Older Adults (OYSCOG)
The Pleurotus oyster species is a common edible mushroom rich in phytochemicals such as proteins, phenolic compounds, dietary fibre and is also particularly rich in ergothioneine, a bioactive known for its neurocognitive benefits. Current research suggests that a mushroom-rich diet may be associated with a lower incidence of age-related neurological disorders, as well as an improvement in the domains of memory and mood.
This randomized double-blind parallel trial investigates the chronic effect (12-weeks) of the equivalent 1 portion of ergothioneine-rich Pleurotus oyster mushrooms (in freeze-dried powdered form), consumed 4 times per week, on cognition and mood, with examination of the potential inflammatory, metabolic, and neurological related mechanisms that may underlie these effects.
Read the detailed description
The Pleurotus oyster species is a common edible mushroom rich in ergothioneine, a bioactive compound with known neurocognitive benefits. The aim of the OYSCOG trial is to investigate the chronic effect (12-weeks) of the equivalent 1 portion of ergothioneine-rich Pleurotus oyster mushrooms (in dried powdered form), consumed 4 times per week, on cognition and mood, with examination of the potential inflammatory, metabolic, and neurological related mechanisms that may underlie these effects.
A power calculation based on similar research investigating the chronic benefits of other mushroom interventions on cognitive function suggests that 72 participants should give sufficient statistical power (with a=0.05, beta=0.80, cohen's d=0.60). This calculation was based on the average cohen's d value obtained from 7 RCTs examining the effect of Lion's Mane, Reishi mushroom or vitamin D enriched mushroom on global cognitive performance. To allow for a 10% attrition rate, 80 healthy older adults aged 60-80 years old will be recruited. Given the parallel design of the RCT, the cohort will be half split to receive either the control maltodextrin intervention (N=40) or the oyster mushroom intervention (N=40).
During this 12-week RCT, participants will attend the University of Reading, Psychology department on three separate occasions. Specifically, in the pre-screening phase, to check for eligibility, the participants interested in our study will be sent a link to REDCap containing online versions of a Health and Lifestyle Questionnaire containing basic demographic questions and the Epic Norfolk Food Frequency Questionnaire (FFQ), to assess their habitual dietary intake. Then, participants, will be contacted to attend a 3-hour familiarisation session at our department, during which the participant's weight, height and blood pressure will be checked, along with a finger-prick, to ensure that the participants are not anaemic. Furthermore, participants will complete the Raven's Progressive Matrices (RPM) measure of fluid intelligence and will perform each of the cognitive battery tasks twice to control for practice effects in the run up to the test session days.
One week after the familiarisation visit, each participant will attend for the baseline test visit, where they will be asked to complete the battery of cognitive and mood tasks and to have their blood pressure and body weight measured. A few participants (n=40, n=20 from each treatment arm) will also be invited to wear an EEG cap using the Brain Products EEG system with 16 channel active electrodes in order to record EEG measurements while performing a simple computerised cognitive task (N-back task) and while resting with eyes open and eyes closed. EEG spectral activity and event-related potential (ERP) data relating to P300 and N200 peaks will be analysed. Finally, a blood test will be performed at the end of the visit. Following the blood draw, the serum will be separated via centrifuge and stored at -80°C until analysis is complete. Blood serum will be analysed for anti-inflammatory and metabolic ability by measuring the levels of fasting lipids (e.g. total cholesterol) and the markers of inflammation (eg cytokines, interleukins), as well as the levels of the brain derived neurotrophic factor (BDNF), a signalling protein known to be related to neuronal signalling and memory function.
At the end of the baseline visit, participants will receive a 12-week supply of sachets containing either maltodextrin or oyster mushroom, depending on their treatment group allocation. They will be asked to consume one sachet 4 times per week for 12-weeks, to be combined with their usual meals. On the 84th day (week 12), participants will be asked to attend the laboratory for their post-visit test day where they will complete the same test procedures as during the baseline visit. Also, at the end of the post-visit day, participants will be asked to complete two dietary surveys: the Epic Norfolk Food Frequency Questionnaire (FFQ), and a brief dietary questionnaire consisting of specialised questions relating to their habitual mushroom intake.
All test visits will take place in the morning, starting between 9am and 10am and finishing before lunchtime. Participants will be asked to follow a low flavonoid diet for 24 hours in advance of each testing visit. Also, they will be asked to consume a standardised breakfast of lightly buttered toast before attending each test visit.
In terms of the mood and cognitive tests, there will be two cognitive test sessions taking place at the familiarisation visit, one at the baseline visit, and then one at the 12-week post-intervention visit, to assess participants' episodic and working memory, psychomotor and executive function and mood domains. Different versions of the cognitive battery will be used at each presentation to minimise learning, and all versions will be matched for difficulty. The mood and cognitive tests will be completed on a computer and should take no longer than 50-60 minutes to complete. The battery will contain the following tasks:
- Positive and Negative Affect Schedule (PANAS-X)- In this mood task, participants are asked to rate their emotion on a 5-point Likert scale, in response to negative emotions (e.g., guilt, fear), positive emotions (e.g., attentiveness, joy) and other affective states (e.g., surprise, shyness).
- Depression, Anxiety and Stress Scale - 21 items (DASS-21)- This 21-item measure assesses symptoms of depression, anxiety and stress. Each item is scored from 0-3 where higher scores indicate higher levels of distress in anxiety (scores range from 0 to >20), depression (0 to >28) and/or stress (0 to >34).
- Rey Auditory Verbal Learning Task (RAVLT)- This episodic memory task consists of 5 consecutive free recalls of the same 15 nouns presented as an auditory list (list A), followed by recall of a further 15 nouns presented as an interference list (list B) which is recalled only once. List A is subsequently recalled straight after list B and then again after a longer delay of around 30 minutes.
- Task Switching Task (TST) - In this executive function task, participants view 8 spaced radii of a circle above and below a bold line and a stimulus digit selected from 1-9 (except 5) appears clockwise in each segment, either above or below the bold line. Depending on the stimulus position in the segments, participants perform different tasks with each being switched every 4 trials.
- Corsi block tapping task (CBTT)- In this spatial working memory task, participants are shown 9 arranged blocks positioned on a computer screen and are asked to reproduce a given sequence by clicking on the blocks (using the mouse) in the same sequence as they see them.
- Simple and complex finger tapping task (SFT \& CFT)- In this psychomotor function task, participants tap on a key as quickly as possible with the index finger of their dominant hand for 1 minute. They then tap out a specific sequence using 4 fingers, again for 1 minute.
- RAVLT word recognition- In this delayed memory task, participants are shown a sequential list of 50 nouns containing the words from lists A and B from the previously described RAVLT task plus 20 additional words not previously heard, and are asked to indicate those from list A.
- N-back (0-Back \& 1-Back versions)- In this working memory and attention task, participants are shown a series of stimuli and they have to respond whether the stimuli match or not the target presented at the beginning of the task. For a subset of participants (n=40), this task will be performed while also taking EEG measurements (using Brain Products software and 16 active electrodes), to examine changes in brain activity in response to the target and non-target trials.
- Subjective mental fatigue- At the end of the cognitive battery participants are asked to rate their mental fatigue level on a 9-point Likert scale.
- Conditions
- Cognitive Change, Mood, Metabolism, Inflammatory Response, Weight Change
- Being tested
- Oyster mushroom, Maltodextrin
- Keywords
- Episodic memory, Executive function, Working memory, Attention, Motor function, Mood, Metabolism, Inflammation
- Medical subject headings
- Body Weight Changes, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oyster mushroomOther
Sachet containing the equivalent of 1 serving (9.39g) of dried ergothioneine-rich Pleurotus oyster mushrooms
MaltodextrinOther
Sachet containing 6.67g of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Oyster mushroom | Experimental | dried oyster mushrooms Receives: Other: Oyster mushroom |
| Placebo | Placebo comparator | maltodextrin Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Affect Schedule (PANAS-X) performance
A validated self-report measure of affective state. The PANAS comprises of two distinct affective states (positive and negative), as well as 11 individual affective states (fear, guilt, sadness, surprise, hostility, shyness, joviality, self-assurance, attentiveness, fatigue and serenity). Subjects use a likert scale from 1 - 5 to indicate how the word relates to how they are currently feeling. As this analysis is exploratory all affective states will be explored.
Measured: Baseline and 12-weeks
Change in Immediate Word Recall performance from the Rey Auditory Verbal Learning Task (RAVLT)
This episodic memory task consists of 5 consecutive free recalls of the same 15 nouns presented as an auditory list (list A), followed by recall of a further 15 nouns presented as an interference list (list B) which is recalled only once. List A is subsequently recalled straight after list B and then again after a longer delay of around 30 minutes.
Measured: Baseline and 12-weeks
Change in the Task Switching Task (TST) performance
In this executive function task, participants view 8 spaced radii of a circle above and below a bold line and a stimulus digit selected from 1-9 (except 5) appears clockwise in each segment, either above or below the bold line. Depending on the stimulus position in the segments, participants perform different tasks with each being switched in every 4 trials. A response of higher or lower than 5 is made for trials below the bold line, and even or odd for numbers above the line. Outcome measures include overall accuracy and reaction time (RT) on correct trials, as well as accuracy and RT on trials where there is a 'switch cost' from stimuli moving from below to above the bold line and vice versa.
Measured: Baseline and 12-weeks
Change in Corsi Block Tapping Test (CBTT) performance
In this spatial working memory task, participants are shown with 9 arranged blocks positioned on a computer screen and are asked to reproduce a given sequence by clicking on the blocks (using the mouse) in the same sequence as they see them.
Measured: Baseline and 12-weeks
Change in Simple Finger Tapping Task (SFTT) performance
In this motor function task, participants tap on a key (eg the letter C) as quickly as possible with the index finger of their dominant hand for 1 minute.
Measured: Baseline and 12-weeks
Change in Complex Finger Tapping Task (CFTT) performance
In this motor function task, participants tap a specific sequence using 4 fingers, for 1 minute.
Measured: Baseline and 12-weeks
Change in RAVLT - Delayed Word Recall performance
After a period of time participants are asked to recall as many words as possible from list A.
Measured: Baseline and 12-weeks
Change in RAVLT - Word Recognition performance
Following the delayed word recall, words from list A, list B and novel words are displayed sequentially on the screen and participants are asked to indicate which words were from list A only.
Measured: Baseline and 12-weeks
Change in Mental Fatigue
Participants are asked to rate in a 9-point Likert scale their mental fatigue levels, ranging from 1: "Not at all mentally fatigued" to 9: "Extremely mentally fatigued".
Measured: Baseline and 12-weeks
Change in 0-Back & 1-Back tasks
The 0-Back \& 1-Back tasks are part of the N-back task that is a measure of working memory where participants are instructed to monitor a series of stimuli and to respond whenever a stimulus is presented that is the same as the one presented n trials previously. Data will be analysed for both accuracy and reaction time on correct trials. For a subset of participants, this task will be conducted while recording EEG in order to monitor change in brain activity in response to target trials.
Measured: Baseline and 12-weeks
Secondary outcomes (10)
Change in Systolic Blood Pressure
Average (triplicate) resting brachial left arm cuffed systolic blood pressure mmHg.
Measured: Baseline and 12-weeks
Change in Diastolic Blood Pressure
Average (triplicate) resting brachial (left arm) cuffed diastolic blood pressure mmHg.
Measured: Baseline and 12-weeks
Change in Heart Rate
Average (triplicate) resting brachial (left arm) cuffed heart rate (beats/minute).
Measured: Baseline and 12-weeks
Change in Body Mass Index (BMI)
Average (triplicate) body mass index (BMI).
Measured: Baseline and 12-weeks
Change in neurotrophic marker
Blood serum levels of the Brain Derived Neurotrophic Factor (BDNF).
Measured: Baseline and 12-weeks
Change in metabolic markers
Blood serum levels of glucose \& triglycerides (TAG).
Measured: Baseline and 12-weeks
Change in inflammatory markers
Blood serum levels of nitrite, nitric oxide (NOX), inducible nitrous oxide synthase (iNOS), cyclooxygenase-2 (COX-2) and Interleukin-6 (IL-6).
Measured: Baseline and 12-weeks
Change in P300
The ERP measure of P300 latency and amplitude will be assessed using EEG (electroencephalography) in a subset of participants during resting state (eyes open and closed) and during the 0-Back \& 1-Back tasks.
Measured: Baseline and 12-weeks
Change in N200
The ERP measure of N200 latency and amplitude will be assessed using EEG (electroencephalography) in a subset of participants during resting state (eyes open and closed) and during the 0-Back \& 1-Back tasks.
Measured: Baseline and 12-weeks
Change in Power Spectral Density (PSD)
The PSD for Alpha, Beta, Gamma, Delta, and Theta bands will be examined during at the resting state (eyes open/eyes close) and while performing the N-Back task.
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Oct 2023
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies 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
- Between- and within-groups (mixed) model
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Mushroom Council
- Responsible party
- Principal investigator, Prof Claire Williams, University of Reading
- Investigators
- Claire M Williams, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846827
- Sponsor's protocol ID
- 2023-088-CW
- Acronym
- OYSCOG
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All personally related collected information will be kept in locked filing cabinets in the Nutritional Unit of the School of Psychology. The digital health questionnaires used for the purpose of pre-screening participants as well as any digital research data will be stored in the Research Electronic Data Capture (REDCap) database, stored on the University secure network cloud. All relevant study outcomes described in the Ethics Review Application Form (including the demographic and anthropometric data (such as age, sex, BMI, blood pressure) as well as the performance scores of the battery tests assessing cognitive function and mood and the results of the blood tests measuring immunological and metabolic function) will be preserved and made available in anonymised form.
Publications
Li IC, Chang HH, Lin CH, Chen WP, Lu TH, Lee LY, Chen YW, Chen YP, Chen CC, Lin DP. Prevention of Early Alzheimer's Disease by Erinacine A-Enriched Hericium erinaceus Mycelia Pilot Double-Blind Placebo-Controlled Study. Front Aging Neurosci. 2020 Jun 3;12:155. doi: 10.3389/fnagi.2020.00155. eCollection 2020.
PubMed 32581767Mori K, Inatomi S, Ouchi K, Azumi Y, Tuchida T. Improving effects of the mushroom Yamabushitake (Hericium erinaceus) on mild cognitive impairment: a double-blind placebo-controlled clinical trial. Phytother Res. 2009 Mar;23(3):367-72. doi: 10.1002/ptr.2634.
PubMed 18844328Saitsu Y, Nishide A, Kikushima K, Shimizu K, Ohnuki K. Improvement of cognitive functions by oral intake of Hericium erinaceus. Biomed Res. 2019;40(4):125-131. doi: 10.2220/biomedres.40.125.
PubMed 31413233Tsuk S, Lev YH, Rotstein A, Carasso R, Zeev A, Netz Y, Dwolatski T, Steiner G. Clinical Effects of a Commercial Supplement of Ophiocordyceps sinensis and Ganoderma lucidum on Cognitive Function of Healthy Young Volunteers. Int J Med Mushrooms. 2017;19(8):667-673. doi: 10.1615/IntJMedMushrooms.2017021202.
PubMed 29199566Wang GH, Wang LH, Wang C, Qin LH. Spore powder of Ganoderma lucidum for the treatment of Alzheimer disease: A pilot study. Medicine (Baltimore). 2018 May;97(19):e0636. doi: 10.1097/MD.0000000000010636.
PubMed 29742702Zajac IT, Barnes M, Cavuoto P, Wittert G, Noakes M. The Effects of Vitamin D-Enriched Mushrooms and Vitamin D3 on Cognitive Performance and Mood in Healthy Elderly Adults: A Randomised, Double-Blinded, Placebo-Controlled Trial. Nutrients. 2020 Dec 16;12(12):3847. doi: 10.3390/nu12123847.
PubMed 33339304Grozier CD, Alves VA, Killen LG, Simpson JD, O'Neal EK, Waldman HS. Four Weeks of Hericium erinaceus Supplementation Does Not Impact Markers of Metabolic Flexibility or Cognition. Int J Exerc Sci. 2022 Oct 1;15(2):1366-1380. doi: 10.70252/XZKO8571. eCollection 2022.
PubMed 36582308
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Investigate the Cognitive, Mood, Anti-inflammatory and Metabolic Effects of Chronic Oyster Mushroom Intervention in Older Adults (OYSCOG)
- ClinicalTrials.gov ID
- NCT06846827
- Acronym / sponsor ID
- OYSCOG / 2023-088-CW
- Conditions
- Cognitive Change, Mood, Metabolism, Inflammatory Response, Weight Change
- Keywords
- Episodic memory, Executive function, Working memory, Attention, Motor function, Mood, Metabolism, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Mushroom Council
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 26 Feb 2025 (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.
The Pleurotus oyster species is a common edible mushroom rich in phytochemicals such as proteins, phenolic compounds, dietary fibre and is also particularly rich in ergothioneine, a bioactive known for its neurocognitive benefits. Current research suggests that a mushroom-rich diet may be associated with a lower incidence of age-related neurological disorders, as well as an improvement in the domains of memory and mood.
This randomized double-blind parallel trial investigates the chronic effect (12-weeks) of the equivalent 1 portion of ergothioneine-rich Pleurotus oyster mushrooms (in freeze-dried powdered form), consumed 4 times per week, on cognition and mood, with examination of the potential inflammatory, metabolic, and neurological related mechanisms that may underlie these effects.
Detailed description
The Pleurotus oyster species is a common edible mushroom rich in ergothioneine, a bioactive compound with known neurocognitive benefits. The aim of the OYSCOG trial is to investigate the chronic effect (12-weeks) of the equivalent 1 portion of ergothioneine-rich Pleurotus oyster mushrooms (in dried powdered form), consumed 4 times per week, on cognition and mood, with examination of the potential inflammatory, metabolic, and neurological related mechanisms that may underlie these effects.
A power calculation based on similar research investigating the chronic benefits of other mushroom interventions on cognitive function suggests that 72 participants should give sufficient statistical power (with a=0.05, beta=0.80, cohen's d=0.60). This calculation was based on the average cohen's d value obtained from 7 RCTs examining the effect of Lion's Mane, Reishi mushroom or vitamin D enriched mushroom on global cognitive performance. To allow for a 10% attrition rate, 80 healthy older adults aged 60-80 years old will be recruited. Given the parallel design of the RCT, the cohort will be half split to receive either the control maltodextrin intervention (N=40) or the oyster mushroom intervention (N=40).
During this 12-week RCT, participants will attend the University of Reading, Psychology department on three separate occasions. Specifically, in the pre-screening phase, to check for eligibility, the participants interested in our study will be sent a link to REDCap containing online versions of a Health and Lifestyle Questionnaire containing basic demographic questions and the Epic Norfolk Food Frequency Questionnaire (FFQ), to assess their habitual dietary intake. Then, participants, will be contacted to attend a 3-hour familiarisation session at our department, during which the participant's weight, height and blood pressure will be checked, along with a finger-prick, to ensure that the participants are not anaemic. Furthermore, participants will complete the Raven's Progressive Matrices (RPM) measure of fluid intelligence and will perform each of the cognitive battery tasks twice to control for practice effects in the run up to the test session days.
One week after the familiarisation visit, each participant will attend for the baseline test visit, where they will be asked to complete the battery of cognitive and mood tasks and to have their blood pressure and body weight measured. A few participants (n=40, n=20 from each treatment arm) will also be invited to wear an EEG cap using the Brain Products EEG system with 16 channel active electrodes in order to record EEG measurements while performing a simple computerised cognitive task (N-back task) and while resting with eyes open and eyes closed. EEG spectral activity and event-related potential (ERP) data relating to P300 and N200 peaks will be analysed. Finally, a blood test will be performed at the end of the visit. Following the blood draw, the serum will be separated via centrifuge and stored at -80°C until analysis is complete. Blood serum will be analysed for anti-inflammatory and metabolic ability by measuring the levels of fasting lipids (e.g. total cholesterol) and the markers of inflammation (eg cytokines, interleukins), as well as the levels of the brain derived neurotrophic factor (BDNF), a signalling protein known to be related to neuronal signalling and memory function.
At the end of the baseline visit, participants will receive a 12-week supply of sachets containing either maltodextrin or oyster mushroom, depending on their treatment group allocation. They will be asked to consume one sachet 4 times per week for 12-weeks, to be combined with their usual meals. On the 84th day (week 12), participants will be asked to attend the laboratory for their post-visit test day where they will complete the same test procedures as during the baseline visit. Also, at the end of the post-visit day, participants will be asked to complete two dietary surveys: the Epic Norfolk Food Frequency Questionnaire (FFQ), and a brief dietary questionnaire consisting of specialised questions relating to their habitual mushroom intake.
All test visits will take place in the morning, starting between 9am and 10am and finishing before lunchtime. Participants will be asked to follow a low flavonoid diet for 24 hours in advance of each testing visit. Also, they will be asked to consume a standardised breakfast of lightly buttered toast before attending each test visit.
In terms of the mood and cognitive tests, there will be two cognitive test sessions taking place at the familiarisation visit, one at the baseline visit, and then one at the 12-week post-intervention visit, to assess participants' episodic and working memory, psychomotor and executive function and mood domains. Different versions of the cognitive battery will be used at each presentation to minimise learning, and all versions will be matched for difficulty. The mood and cognitive tests will be completed on a computer and should take no longer than 50-60 minutes to complete. The battery will contain the following tasks:
- Positive and Negative Affect Schedule (PANAS-X)- In this mood task, participants are asked to rate their emotion on a 5-point Likert scale, in response to negative emotions (e.g., guilt, fear), positive emotions (e.g., attentiveness, joy) and other affective states (e.g., surprise, shyness).
- Depression, Anxiety and Stress Scale - 21 items (DASS-21)- This 21-item measure assesses symptoms of depression, anxiety and stress. Each item is scored from 0-3 where higher scores indicate higher levels of distress in anxiety (scores range from 0 to >20), depression (0 to >28) and/or stress (0 to >34).
- Rey Auditory Verbal Learning Task (RAVLT)- This episodic memory task consists of 5 consecutive free recalls of the same 15 nouns presented as an auditory list (list A), followed by recall of a further 15 nouns presented as an interference list (list B) which is recalled only once. List A is subsequently recalled straight after list B and then again after a longer delay of around 30 minutes.
- Task Switching Task (TST) - In this executive function task, participants view 8 spaced radii of a circle above and below a bold line and a stimulus digit selected from 1-9 (except 5) appears clockwise in each segment, either above or below the bold line. Depending on the stimulus position in the segments, participants perform different tasks with each being switched every 4 trials.
- Corsi block tapping task (CBTT)- In this spatial working memory task, participants are shown 9 arranged blocks positioned on a computer screen and are asked to reproduce a given sequence by clicking on the blocks (using the mouse) in the same sequence as they see them.
- Simple and complex finger tapping task (SFT \& CFT)- In this psychomotor function task, participants tap on a key as quickly as possible with the index finger of their dominant hand for 1 minute. They then tap out a specific sequence using 4 fingers, again for 1 minute.
- RAVLT word recognition- In this delayed memory task, participants are shown a sequential list of 50 nouns containing the words from lists A and B from the previously described RAVLT task plus 20 additional words not previously heard, and are asked to indicate those from list A.
- N-back (0-Back \& 1-Back versions)- In this working memory and attention task, participants are shown a series of stimuli and they have to respond whether the stimuli match or not the target presented at the beginning of the task. For a subset of participants (n=40), this task will be performed while also taking EEG measurements (using Brain Products software and 16 active electrodes), to examine changes in brain activity in response to the target and non-target trials.
- Subjective mental fatigue- At the end of the cognitive battery participants are asked to rate their mental fatigue level on a 9-point Likert scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Between- and within-groups (mixed) model
| Arm | Type | Receives |
|---|---|---|
| Oyster mushroom | Experimental | Other: Oyster mushroomdried oyster mushrooms |
| Placebo | Placebo comparator | Other: Maltodextrinmaltodextrin |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 60-80 years old
- Have normal vision and hearing
- Have a Body mass index (BMI<=30)
- Have healthy status
Key exclusion criteria (10 listed)
- Smokers
- Vegans/vegetarians
- Being diagnosed with a psychiatric/neurological condition (eg., stroke, schizophrenia, depression, cognitive impairement, dementia)
- Being diagnosed with a learning/behavioural disorder (e.g. dyslexia, autism, ADHD)
- Being diagnosed with a metabolic disease (eg., type I/II diabetes and cardiovascular disease), or suffer from unmediated hypertension or thrombosis related disorders, or suffer from cancer, kidney or liver disease
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 |
|---|---|---|
| Oyster mushroomSachet containing the equivalent of 1 serving (9.39g) of dried ergothioneine-rich Pleurotus oyster mushrooms | Other | Oyster mushroom |
| MaltodextrinSachet containing 6.67g of maltodextrin | Other | Placebo |
Primary outcome
Change in Positive and Negative Affect Schedule (PANAS-X) performance
Time frame: Baseline and 12-weeks
A validated self-report measure of affective state. The PANAS comprises of two distinct affective states (positive and negative), as well as 11 individual affective states (fear, guilt, sadness, surprise, hostility, shyness, joviality, self-assurance, attentiveness, fatigue and serenity). Subjects use a likert scale from 1 - 5 to indicate how the word relates to how they are currently feeling. As this analysis is exploratory all affective states will be explored.
Change in Immediate Word Recall performance from the Rey Auditory Verbal Learning Task (RAVLT)
Time frame: Baseline and 12-weeks
This episodic memory task consists of 5 consecutive free recalls of the same 15 nouns presented as an auditory list (list A), followed by recall of a further 15 nouns presented as an interference list (list B) which is recalled only once. List A is subsequently recalled straight after list B and then again after a longer delay of around 30 minutes.
Change in the Task Switching Task (TST) performance
Time frame: Baseline and 12-weeks
In this executive function task, participants view 8 spaced radii of a circle above and below a bold line and a stimulus digit selected from 1-9 (except 5) appears clockwise in each segment, either above or below the bold line. Depending on the stimulus position in the segments, participants perform different tasks with each being switched in every 4 trials. A response of higher or lower than 5 is made for trials below the bold line, and even or odd for numbers above the line. Outcome measures include overall accuracy and reaction time (RT) on correct trials, as well as accuracy and RT on trials where there is a 'switch cost' from stimuli moving from below to above the bold line and vice versa.
Change in Corsi Block Tapping Test (CBTT) performance
Time frame: Baseline and 12-weeks
In this spatial working memory task, participants are shown with 9 arranged blocks positioned on a computer screen and are asked to reproduce a given sequence by clicking on the blocks (using the mouse) in the same sequence as they see them.
Change in Simple Finger Tapping Task (SFTT) performance
Time frame: Baseline and 12-weeks
In this motor function task, participants tap on a key (eg the letter C) as quickly as possible with the index finger of their dominant hand for 1 minute.
Change in Complex Finger Tapping Task (CFTT) performance
Time frame: Baseline and 12-weeks
In this motor function task, participants tap a specific sequence using 4 fingers, for 1 minute.
Change in RAVLT - Delayed Word Recall performance
Time frame: Baseline and 12-weeks
After a period of time participants are asked to recall as many words as possible from list A.
Change in RAVLT - Word Recognition performance
Time frame: Baseline and 12-weeks
Following the delayed word recall, words from list A, list B and novel words are displayed sequentially on the screen and participants are asked to indicate which words were from list A only.
Change in Mental Fatigue
Time frame: Baseline and 12-weeks
Participants are asked to rate in a 9-point Likert scale their mental fatigue levels, ranging from 1: "Not at all mentally fatigued" to 9: "Extremely mentally fatigued".
Change in 0-Back & 1-Back tasks
Time frame: Baseline and 12-weeks
The 0-Back \& 1-Back tasks are part of the N-back task that is a measure of working memory where participants are instructed to monitor a series of stimuli and to respond whenever a stimulus is presented that is the same as the one presented n trials previously. Data will be analysed for both accuracy and reaction time on correct trials. For a subset of participants, this task will be conducted while recording EEG in order to monitor change in brain activity in response to target trials.
10 secondary outcomes
Change in Systolic Blood Pressure
Time frame: Baseline and 12-weeks
Change in Diastolic Blood Pressure
Time frame: Baseline and 12-weeks
Change in Heart Rate
Time frame: Baseline and 12-weeks
Change in Body Mass Index (BMI)
Time frame: Baseline and 12-weeks
Change in neurotrophic marker
Time frame: Baseline and 12-weeks
Change in metabolic markers
Time frame: Baseline and 12-weeks
Change in inflammatory markers
Time frame: Baseline and 12-weeks
Change in P300
Time frame: Baseline and 12-weeks
Change in N200
Time frame: Baseline and 12-weeks
Change in Power Spectral Density (PSD)
Time frame: Baseline and 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 4 Mar 2025.
- Background: PubMed 32581767Li IC, Chang HH, Lin CH, Chen WP, Lu TH, Lee LY, Chen YW, Chen YP, Chen CC, Lin DP. Prevention of Early Alzheimer's Disease by Erinacine A-Enriched Hericium erinaceus Mycelia Pilot Double-Blind Placebo-Controlled Study. Front Aging Neurosci. 2020 Jun 3;12:155. doi: 10.3389/fnagi.2020.00155. eCollection 2020.
- Background: PubMed 18844328Mori K, Inatomi S, Ouchi K, Azumi Y, Tuchida T. Improving effects of the mushroom Yamabushitake (Hericium erinaceus) on mild cognitive impairment: a double-blind placebo-controlled clinical trial. Phytother Res. 2009 Mar;23(3):367-72. doi: 10.1002/ptr.2634.
- Background: PubMed 31413233Saitsu Y, Nishide A, Kikushima K, Shimizu K, Ohnuki K. Improvement of cognitive functions by oral intake of Hericium erinaceus. Biomed Res. 2019;40(4):125-131. doi: 10.2220/biomedres.40.125.
- Background: PubMed 29199566Tsuk S, Lev YH, Rotstein A, Carasso R, Zeev A, Netz Y, Dwolatski T, Steiner G. Clinical Effects of a Commercial Supplement of Ophiocordyceps sinensis and Ganoderma lucidum on Cognitive Function of Healthy Young Volunteers. Int J Med Mushrooms. 2017;19(8):667-673. doi: 10.1615/IntJMedMushrooms.2017021202.
- Background: PubMed 29742702Wang GH, Wang LH, Wang C, Qin LH. Spore powder of Ganoderma lucidum for the treatment of Alzheimer disease: A pilot study. Medicine (Baltimore). 2018 May;97(19):e0636. doi: 10.1097/MD.0000000000010636.
- Background: PubMed 33339304Zajac IT, Barnes M, Cavuoto P, Wittert G, Noakes M. The Effects of Vitamin D-Enriched Mushrooms and Vitamin D3 on Cognitive Performance and Mood in Healthy Elderly Adults: A Randomised, Double-Blinded, Placebo-Controlled Trial. Nutrients. 2020 Dec 16;12(12):3847. doi: 10.3390/nu12123847.
- Background: PubMed 36582308Grozier CD, Alves VA, Killen LG, Simpson JD, O'Neal EK, Waldman HS. Four Weeks of Hericium erinaceus Supplementation Does Not Impact Markers of Metabolic Flexibility or Cognition. Int J Exerc Sci. 2022 Oct 1;15(2):1366-1380. doi: 10.70252/XZKO8571. eCollection 2022.
- Individual participant dataSharing planned: No. All personally related collected information will be kept in locked filing cabinets in the Nutritional Unit of the School of Psychology. The digital health questionnaires used for the purpose of pre-screening participants as well as any digital research data will be stored in the Research Electronic Data Capture (REDCap) database, stored on the University secure network cloud. All relevant study outcomes described in the Ethics Review Application Form (including the demographic and anthropometric data (such as age, sex, BMI, blood pressure) as well as the performance scores of the battery tests assessing cognitive function and mood and the results of the blood tests measuring immunological and metabolic function) will be preserved and made available in anonymised form.
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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 M Williams 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 Oyster mushroom and Maltodextrin in people with Cognitive Change 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 4 inclusion and 10 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 4 Mar 2025. 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?
Change in Positive and Negative Affect Schedule (PANAS-X) performance (time frame: Baseline and 12-weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06846827, which also lists 7 linked publications.
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 4 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.