Cognitive ChangeOYSACONCT05594329
Neurological, Inflammatory and Metabolic Effects of Acute Mushroom Intervention in Older Adults
A study testing Instant noodle soup containing containing the equivalent of 2 servings (18.78g) of powdered Pleurotus oyster mushroom., Instant noodle soup containing containing the equivalent of 1 serving (9.39g) of powdered Pleurotus oyster mushroom. and Instant noodle soup containing containing the equivalent of 0.5 serving (4.70g) of powdered Pleurotus oyster mushroom. in people with Cognitive Change and Mood, run by University of Reading at 1 site in United Kingdom.
Trial summary
This randomized crossover trial (RCT) investigates the acute effect (over a 6-hour period) of a meal containing varying serving sizes (doses) of freeze-dried oyster mushroom powder, on the cognitive behaviour and markers of metabolism and inflammation related to neuronal health in healthy adults aged 60-80 years old. 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?
- Instant noodle soup containing containing the equivalent of 2 servings (18.78g) of powdered Pleurotus oyster mushroom., Instant noodle soup containing containing the equivalent of 1 serving (9.39g) of powdered Pleurotus oyster mushroom. and Instant noodle soup containing containing the equivalent of 0.5 serving (4.70g) of powdered Pleurotus oyster mushroom.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2022to 22 Dec 2022
- 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 healthy status
- Have a BMI<30
Who cannot join
- Smokers or those consuming more than the recommended units of alcohol per week
- Vegetarians/ Vegans
- Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, cognitive dementia)
- Being diagnosed with cardiometabolic disease (including type II diabetes and cardiovascular disease), or suffer from hypertension or thrombosis related disorders
- Being anaemic
- Currently taking regular vitamin supplements or disease medication such as anticoagulant or antiplatelet medication and antidepressants etc
- Diagnosed with an eating disorder
- Be allergic to mushrooms, or any other nutrients present in the intervention meals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Investigate the Neurological, Inflammatory and Metabolic Effects of Acute Mushroom Intervention in Older Adults (OYSACO)
This randomized crossover trial (RCT) investigates the acute effect (over a 6-hour period) of a meal containing varying serving sizes (doses) of freeze-dried oyster mushroom powder, on the cognitive behaviour and markers of metabolism and inflammation related to neuronal health in healthy adults aged 60-80 years old. The study will involve a screening visit and four testing visits, with a week interval between each. During the four testing visits, cognitive-mood battery tests will be taken at baseline and then at 2-, 4- and 6-hour intervals following the consumption of the intervention meal. Also, a blood draw will be taken at the end of each testing visit day to allow the determination of inflammatory, metabolic and neuronal markers.
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 OYSACO RCT is to provide a clearer understanding of how a meal containing varying serving sizes (doses) of freeze-dried oyster mushroom powder, may acutely regulate cognitive improvements in humans during the immediate postprandial period. The investigators will investigate the neurological and physiological changes underlying these benefits.
During the OYSACO RCT, participants will attend the University of Reading, Psychology department on five separate occasions, with a week interval between each visit. 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 (eg age, sex, heigh, weight, nationality, disease history and medication use) and the Epic Norfolk Food Frequency Questionnaire (FFQ), to assess their habitual dietary intake. Then, participants, will be contacted to attend a 2-hour screening 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. Three drops of blood will be taken from the tip of the either the index or ring finger for this measure. Furthermore, participants will complete the Raven's Progressive Matrices (RPM) measure of fluid intelligence and will perform the cognitive battery tasks twice to control for practice effects in the run up to the test session days.
One week after the screening visit, each participant will attend a further four test sessions, each separated by a week, where they will receive a different dose of freeze-dried oyster mushrooms. The order of intervention will be randomised, and participants will be asked to follow a low fibre and flavonoid diet for 48 hours in advance of testing. Before each test visit, the participants will be asked to fast for 12-hours and then to consume only a slice of toast with butter and 1 glass of water at 07:00 a.m., before attending the university. As soon as the participants arrive at our laboratory at 08:00 a.m., baseline cognitive and mood tests will be completed. After completing the baseline measures, the participants will receive one of the 3 mushroom interventions or the control intervention. The procedure on each test day will be identical except for the intervention meal. Specifically, the intervention meals will consist of a noodle soup containing the equivalent of 0.5, 1 and 2 servings of powdered Pleurotus oyster mushroom or a calorie-matched control non-mushroom noodle soup containing a mixture of maltodextrin and cornflour. The ingredients present in the intervention meals are all standard ingredients used in the food industry and are included at safe levels. Allergy information will be available on request. The dried oyster mushroom powder was prepared according to the Federal Good Manufacturing Practices and US Food Guidelines and is certified free from unauthorised pesticides, and microbiological and other contaminants.
Two-hours after consuming the intervention, the participants will be asked to complete the same cognitive and mood tests, and a calorie-matched lunch will then be provided between 12:00-12:30 p.m. containing a chicken sandwich, a packet of crisps and a glass of water. Participants will then be asked to complete the cognitive and mood tests a further two times (4-hours and 6-hours post-intervention) and a blood test will be drawn at the end of the visit.
In addition to the cognitive tests, palatability measures will be taken immediately after the consumption of the intervention meal while at the end of each cognitive test session (at baseline, 2-, 4- and 6-hours), ratings of subjective appetite and fullness will be recorded using an online analogue scale. At the end of the 5-week study, participants will be asked to complete a brief dietary questionnaire, consisting of specialised questions, relating to their habitual mushroom intake.
In terms of cognitive testing, there will be four cognitive task battery sessions taking place at baseline and then at 2-, 4-and 6-hours post-intervention, to assess participants' episodic and working memory, psychomotor and executive function and mood domains. Each battery will be matched for difficulty and order of presentation will be randomised. Although the exact cognitive battery is yet to be confirmed, all tasks will be completed on the computer and should take no longer than 45 minutes to complete. The battery is likely to contain the following or similar tasks:
- Positive and Negative Affect Schedule (PANAS-SF)- In this mood task, participants are asked to rate their emotion on a 5-point Likert scale, in response to 20 mood related adjectives (10 relating to positive emotions and 10 to negative emotions).
- 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.
- Corsi block tapping task (CBTT)- In this spatial working memory task, participants are shown with 9 arranged blocks positioned on a computer screen and are asked to reproduce given sequence by clicking on the blocks (using the mouse) in the same sequence as they see them.
- Simple and complex finger tapping task- In this motor 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.
- 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 in every 4 trials.
- RAVLT word recall- After a period of time, participants are asked to recall as many words as possible from list A.
- 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.
During each test day, participants will have one 9-millilitre blood draw taken from their arm, 6-hours after receiving the intervention meal. Following each draw, the serum will be separated via centrifuge and stored at at -80°C until analysis is complete. Whole blood samples will not be stored at any point during the study. Blood serum will be analysed for anti-inflammatory and metabolic ability by measuring the levels of fasting glucose and lipids in the blood, the markers of inflammation, 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.
- Conditions
- Cognitive Change, Mood, Metabolism, Inflammatory Response, Satiety
- Being tested
- Instant noodle soup containing containing the equivalent of 2 servings (18.78g) of powdered Pleurotus oyster mushroom., Instant noodle soup containing containing the equivalent of 1 serving (9.39g) of powdered Pleurotus oyster mushroom., Instant noodle soup containing containing the equivalent of 0.5 serving (4.70g) of powdered Pleurotus oyster mushroom., Control instant noodle soup
- Keywords
- Cognition, Mood, Inflammation, Metabolism
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instant noodle soup containing containing the equivalent of 2 servings (18.78g) of powdered Pleurotus oyster mushroom.Other
Ingredients: celery, garlic, ginger, gluten, polyphosphate, parsley, pepper, potassium carbonates, dried Pleurotus oyster mushroom, salt, sodium, sunflower oil, turmeric, yeast extract and wheat flour.
Instant noodle soup containing containing the equivalent of 1 serving (9.39g) of powdered Pleurotus oyster mushroom.Other
Ingredients: cornflour, celery, garlic, ginger, gluten, polyphosphate, parsley, pepper, potassium carbonates, dried Pleurotus oyster mushroom, maltodextrin, salt, sodium, sunflower oil, turmeric, yeast extract and wheat flour.
Instant noodle soup containing containing the equivalent of 0.5 serving (4.70g) of powdered Pleurotus oyster mushroom.Other
Ingredients: cornflour, celery, garlic, ginger, gluten, polyphosphate, parsley, pepper, potassium carbonates, dried Pleurotus oyster mushroom, maltodextrin, salt, sodium, sunflower oil, turmeric, yeast extract and wheat flour.
Control instant noodle soupOther
Ingredients: cornflour, celery, garlic, ginger, gluten, polyphosphate, parsley, pepper, potassium carbonates, maltodextrin, salt, sodium, sunflower oil, turmeric, yeast extract and wheat flour.
| Study group | Role | What they receive |
|---|---|---|
| Experimental meal 1 | Experimental | Instant noodle soup containing 2 servings of dried Pleurotus oyster mushroom. Receives: Other: Instant noodle soup containing containing the equivalent of 2 servings (18.78g) of powdered Pleurotus oyster mushroom. |
| Experimental meal 2 | Experimental | Instant noodle soup containing 1 serving of dried Pleurotus oyster mushroom. Receives: Other: Instant noodle soup containing containing the equivalent of 1 serving (9.39g) of powdered Pleurotus oyster mushroom. |
| Experimental meal 3 | Experimental | Instant noodle soup containing 0.5 serving of dried Pleurotus oyster mushroom. Receives: Other: Instant noodle soup containing containing the equivalent of 0.5 serving (4.70g) of powdered Pleurotus oyster mushroom. |
| Control meal | Placebo comparator | Instant noodle soup containing cornflour and maltodextrin in a 2.5:1 ratio. Receives: Other: Control instant noodle soup |
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-SF) performance
In this validated self-reported mood task, participants are asked to rate their emotion. 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: 2-hours post-intervention
Change in Positive and Negative Affect Schedule (PANAS-SF) performance
In this validated self-reported mood task, participants are asked to rate their emotion. 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: 4-hours post-intervention
Change in Positive and Negative Affect Schedule (PANAS-SF) performance
In this validated self-reported mood task, participants are asked to rate their emotion. 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: 6-hours post-intervention
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: 2-hours post-intervention
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: 4-hours post-intervention
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: 6-hours post-intervention
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: 2-hours post-intervention
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: 4-hours post-intervention
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: 6-hours post-intervention
Change in Simple and complex finger tapping task (SFTT & CFTT) performance
In this motor 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.
Measured: 2-hours post-intervention
Change in Simple and complex finger tapping task (SFTT & CFTT) performance
In this motor 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.
Measured: 4-hours post-intervention
Change in Simple and complex finger tapping task (SFTT & CFTT) performance
In this motor 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.
Measured: 6-hours post-intervention
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: 2-hours post-intervention
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: 4-hours post-intervention
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: 6-hours post-intervention
Change in RAVLT - Delayed Word Recall performance
After a period of time subject are asked to recall as many words as possible from list A.
Measured: 2-hours post-intervention
Change in RAVLT - Delayed Word Recall performance
After a period of time subject are asked to recall as many words as possible from list A.
Measured: 4-hours post-intervention
Change in RAVLT - Delayed Word Recall performance
After a period of time subject are asked to recall as many words as possible from list A.
Measured: 6-hours post-intervention
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: 2-hours post-intervention
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: 4-hours post-intervention
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: 6-hours post-intervention
Secondary outcomes (10)
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption
Satiety Measure recorded on a 100 millimetre scale. Scores closer to 0 millimetres indicate less hunger, less satiety and less fullness - taken as a negative outcome, and less desire for prospective food consumption or consume something sweet, salty, savoury or fatty - taken as a positive outcome.
Measured: Baseline
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption
Satiety Measure recorded on a 100 millimetre scale. Scores closer to 0 millimetres indicate less hunger, less satiety and less fullness - taken as a negative outcome, and less desire for prospective food consumption or consume something sweet, salty, savoury or fatty - taken as a positive outcome.
Measured: 2-hours post-intervention
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption
Satiety Measure recorded on a 100 millimetre scale. Scores closer to 0 millimetres indicate less hunger, less satiety and less fullness - taken as a negative outcome, and less desire for prospective food consumption or consume something sweet, salty, savoury or fatty - taken as a positive outcome.
Measured: 4-hours post-intervention
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption
Satiety Measure recorded on a 100 millimetre scale. Scores closer to 0 millimetres indicate less hunger, less satiety and less fullness - taken as a negative outcome, and less desire for prospective food consumption or consume something sweet, salty, savoury or fatty - taken as a positive outcome.
Measured: 6-hours post-intervention
Visual analogue measure of palatability of the intervention meal
Palatability Measure recorded on a 100 millimetre scale. Scores closer to 0 millimetres indicate good visual appeal, good smell, good taste and good overall palatability - taken as a positive outcome.
Measured: 1-hour post-intervention
Neurotrophic marker
Blood serum levels of BDNF.
Measured: 6-hours post-intervention
Metabolic marker- Glucose
Blood serum levels of glucose
Measured: 6-hours post-intervention
Metabolic marker- Insulin
Blood serum levels of insulin
Measured: 6-hours post-intervention
Metabolic marker- Triglycerides
Blood serum levels of triglycerides (TAG)
Measured: 6-hours post-intervention
Inflammatory marker
Blood serum levels of Interleukin-6 (IL-6)
Measured: 6-hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start15 Aug 2022
- Primary completion1 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 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 Williams, PhD, Principal investigator, School of Psychology and Clinical Languages, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594329
- Sponsor's protocol ID
- 22/10
- Acronym
- OYSACO
- Status last verified
- May 2023
- First submitted
- 11 Oct 2022
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All personally related collected information, including the paper consent forms, 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 (UREC). 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, so that they can be consulted and re-used by others.
Publications
Ba DM, Gao X, Al-Shaar L, Muscat J, Chinchilli VM, Ssentongo P, Beelman RB, Richie J. Mushroom intake and cognitive performance among US older adults: the National Health and Nutrition Examination Survey, 2011-2014. Br J Nutr. 2022 Dec 14;128(11):2241-2248. doi: 10.1017/S0007114521005195. Epub 2022 Feb 4.
PubMed 35115063Bingham S, Luben R, Welch A, Low YL, Khaw KT, Wareham N, Day N. Associations between dietary methods and biomarkers, and between fruits and vegetables and risk of ischaemic heart disease, in the EPIC Norfolk Cohort Study. Int J Epidemiol. 2008 Oct;37(5):978-87. doi: 10.1093/ije/dyn111. Epub 2008 Jun 25.
PubMed 18579574Gregory J, Vengalasetti YV, Bredesen DE, Rao RV. Neuroprotective Herbs for the Management of Alzheimer's Disease. Biomolecules. 2021 Apr 8;11(4):543. doi: 10.3390/biom11040543.
PubMed 33917843Rahman MA, Abdullah N, Aminudin N. Interpretation of mushroom as a common therapeutic agent for Alzheimer's disease and cardiovascular diseases. Crit Rev Biotechnol. 2016 Dec;36(6):1131-1142. doi: 10.3109/07388551.2015.1100585. Epub 2015 Oct 30.
PubMed 26514091Kleftaki SA, Simati S, Amerikanou C, Gioxari A, Tzavara C, Zervakis GI, Kalogeropoulos N, Kokkinos A, Kaliora AC. Pleurotus eryngii improves postprandial glycaemia, hunger and fullness perception, and enhances ghrelin suppression in people with metabolically unhealthy obesity. Pharmacol Res. 2022 Jan;175:105979. doi: 10.1016/j.phrs.2021.105979. Epub 2021 Nov 16.
PubMed 34798266Dicks L, Jakobs L, Sari M, Hambitzer R, Ludwig N, Simon MC, Stehle P, Stoffel-Wagner B, Helfrich HP, Ahlborn J, Ruhl M, Hartmann B, Holst JJ, Ellinger S. Fortifying a meal with oyster mushroom powder beneficially affects postprandial glucagon-like peptide-1, non-esterified free fatty acids and hunger sensation in adults with impaired glucose tolerance: a double-blind randomized controlled crossover trial. Eur J Nutr. 2022 Mar;61(2):687-701. doi: 10.1007/s00394-021-02674-1. Epub 2021 Sep 10.
PubMed 34505919
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Investigate the Neurological, Inflammatory and Metabolic Effects of Acute Mushroom Intervention in Older Adults (OYSACO)
- ClinicalTrials.gov ID
- NCT05594329
- Acronym / sponsor ID
- OYSACO / 22/10
- Conditions
- Cognitive Change, Mood, Metabolism, Inflammatory Response, Satiety
- Keywords
- Cognition, Mood, Inflammation, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Mushroom Council
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 26 Oct 2022 (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.
This randomized crossover trial (RCT) investigates the acute effect (over a 6-hour period) of a meal containing varying serving sizes (doses) of freeze-dried oyster mushroom powder, on the cognitive behaviour and markers of metabolism and inflammation related to neuronal health in healthy adults aged 60-80 years old. The study will involve a screening visit and four testing visits, with a week interval between each. During the four testing visits, cognitive-mood battery tests will be taken at baseline and then at 2-, 4- and 6-hour intervals following the consumption of the intervention meal. Also, a blood draw will be taken at the end of each testing visit day to allow the determination of inflammatory, metabolic and neuronal markers.
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 OYSACO RCT is to provide a clearer understanding of how a meal containing varying serving sizes (doses) of freeze-dried oyster mushroom powder, may acutely regulate cognitive improvements in humans during the immediate postprandial period. The investigators will investigate the neurological and physiological changes underlying these benefits.
During the OYSACO RCT, participants will attend the University of Reading, Psychology department on five separate occasions, with a week interval between each visit. 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 (eg age, sex, heigh, weight, nationality, disease history and medication use) and the Epic Norfolk Food Frequency Questionnaire (FFQ), to assess their habitual dietary intake. Then, participants, will be contacted to attend a 2-hour screening 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. Three drops of blood will be taken from the tip of the either the index or ring finger for this measure. Furthermore, participants will complete the Raven's Progressive Matrices (RPM) measure of fluid intelligence and will perform the cognitive battery tasks twice to control for practice effects in the run up to the test session days.
One week after the screening visit, each participant will attend a further four test sessions, each separated by a week, where they will receive a different dose of freeze-dried oyster mushrooms. The order of intervention will be randomised, and participants will be asked to follow a low fibre and flavonoid diet for 48 hours in advance of testing. Before each test visit, the participants will be asked to fast for 12-hours and then to consume only a slice of toast with butter and 1 glass of water at 07:00 a.m., before attending the university. As soon as the participants arrive at our laboratory at 08:00 a.m., baseline cognitive and mood tests will be completed. After completing the baseline measures, the participants will receive one of the 3 mushroom interventions or the control intervention. The procedure on each test day will be identical except for the intervention meal. Specifically, the intervention meals will consist of a noodle soup containing the equivalent of 0.5, 1 and 2 servings of powdered Pleurotus oyster mushroom or a calorie-matched control non-mushroom noodle soup containing a mixture of maltodextrin and cornflour. The ingredients present in the intervention meals are all standard ingredients used in the food industry and are included at safe levels. Allergy information will be available on request. The dried oyster mushroom powder was prepared according to the Federal Good Manufacturing Practices and US Food Guidelines and is certified free from unauthorised pesticides, and microbiological and other contaminants.
Two-hours after consuming the intervention, the participants will be asked to complete the same cognitive and mood tests, and a calorie-matched lunch will then be provided between 12:00-12:30 p.m. containing a chicken sandwich, a packet of crisps and a glass of water. Participants will then be asked to complete the cognitive and mood tests a further two times (4-hours and 6-hours post-intervention) and a blood test will be drawn at the end of the visit.
In addition to the cognitive tests, palatability measures will be taken immediately after the consumption of the intervention meal while at the end of each cognitive test session (at baseline, 2-, 4- and 6-hours), ratings of subjective appetite and fullness will be recorded using an online analogue scale. At the end of the 5-week study, participants will be asked to complete a brief dietary questionnaire, consisting of specialised questions, relating to their habitual mushroom intake.
In terms of cognitive testing, there will be four cognitive task battery sessions taking place at baseline and then at 2-, 4-and 6-hours post-intervention, to assess participants' episodic and working memory, psychomotor and executive function and mood domains. Each battery will be matched for difficulty and order of presentation will be randomised. Although the exact cognitive battery is yet to be confirmed, all tasks will be completed on the computer and should take no longer than 45 minutes to complete. The battery is likely to contain the following or similar tasks:
- Positive and Negative Affect Schedule (PANAS-SF)- In this mood task, participants are asked to rate their emotion on a 5-point Likert scale, in response to 20 mood related adjectives (10 relating to positive emotions and 10 to negative emotions).
- 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.
- Corsi block tapping task (CBTT)- In this spatial working memory task, participants are shown with 9 arranged blocks positioned on a computer screen and are asked to reproduce given sequence by clicking on the blocks (using the mouse) in the same sequence as they see them.
- Simple and complex finger tapping task- In this motor 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.
- 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 in every 4 trials.
- RAVLT word recall- After a period of time, participants are asked to recall as many words as possible from list A.
- 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.
During each test day, participants will have one 9-millilitre blood draw taken from their arm, 6-hours after receiving the intervention meal. Following each draw, the serum will be separated via centrifuge and stored at at -80°C until analysis is complete. Whole blood samples will not be stored at any point during the study. Blood serum will be analysed for anti-inflammatory and metabolic ability by measuring the levels of fasting glucose and lipids in the blood, the markers of inflammation, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental meal 1 | Experimental | Other: Instant noodle soup containing containing the equivalent of 2 servings (18.78g) of powdered Pleurotus oyster mushroom.Instant noodle soup containing 2 servings of dried Pleurotus oyster mushroom. |
| Experimental meal 2 | Experimental | Other: Instant noodle soup containing containing the equivalent of 1 serving (9.39g) of powdered Pleurotus oyster mushroom.Instant noodle soup containing 1 serving of dried Pleurotus oyster mushroom. |
| Experimental meal 3 | Experimental | Other: Instant noodle soup containing containing the equivalent of 0.5 serving (4.70g) of powdered Pleurotus oyster mushroom.Instant noodle soup containing 0.5 serving of dried Pleurotus oyster mushroom. |
| Control meal | Placebo comparator | Other: Control instant noodle soupInstant noodle soup containing cornflour and maltodextrin in a 2.5:1 ratio. |
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 healthy status
- Have a BMI<30
Key exclusion criteria (8 listed)
- Smokers or those consuming more than the recommended units of alcohol per week
- Vegetarians/ Vegans
- Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, cognitive dementia)
- Being diagnosed with cardiometabolic disease (including type II diabetes and cardiovascular disease), or suffer from hypertension or thrombosis related disorders
- Being anaemic
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 |
|---|---|---|
| Instant noodle soup containing containing the equivalent of 2 servings (18.78g) of powdered Pleurotus oyster mushroom.Ingredients: celery, garlic, ginger, gluten, polyphosphate, parsley, pepper, potassium carbonates, dried Pleurotus oyster mushroom, salt, sodium, sunflower oil, turmeric, yeast extract and wheat flour. | Other | Experimental meal 1 |
| Instant noodle soup containing containing the equivalent of 1 serving (9.39g) of powdered Pleurotus oyster mushroom.Ingredients: cornflour, celery, garlic, ginger, gluten, polyphosphate, parsley, pepper, potassium carbonates, dried Pleurotus oyster mushroom, maltodextrin, salt, sodium, sunflower oil, turmeric, yeast extract and wheat flour. | Other | Experimental meal 2 |
| Instant noodle soup containing containing the equivalent of 0.5 serving (4.70g) of powdered Pleurotus oyster mushroom.Ingredients: cornflour, celery, garlic, ginger, gluten, polyphosphate, parsley, pepper, potassium carbonates, dried Pleurotus oyster mushroom, maltodextrin, salt, sodium, sunflower oil, turmeric, yeast extract and wheat flour. | Other | Experimental meal 3 |
| Control instant noodle soupIngredients: cornflour, celery, garlic, ginger, gluten, polyphosphate, parsley, pepper, potassium carbonates, maltodextrin, salt, sodium, sunflower oil, turmeric, yeast extract and wheat flour. | Other | Control meal |
Primary outcome
Change in Positive and Negative Affect Schedule (PANAS-SF) performance
Time frame: 2-hours post-intervention
In this validated self-reported mood task, participants are asked to rate their emotion. 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 Positive and Negative Affect Schedule (PANAS-SF) performance
Time frame: 4-hours post-intervention
In this validated self-reported mood task, participants are asked to rate their emotion. 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 Positive and Negative Affect Schedule (PANAS-SF) performance
Time frame: 6-hours post-intervention
In this validated self-reported mood task, participants are asked to rate their emotion. 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: 2-hours post-intervention
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 Immediate Word Recall performance from the Rey Auditory Verbal Learning Task (RAVLT)
Time frame: 4-hours post-intervention
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 Immediate Word Recall performance from the Rey Auditory Verbal Learning Task (RAVLT)
Time frame: 6-hours post-intervention
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 Corsi Block Tapping Test (CBTT) performance
Time frame: 2-hours post-intervention
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 Corsi Block Tapping Test (CBTT) performance
Time frame: 4-hours post-intervention
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 Corsi Block Tapping Test (CBTT) performance
Time frame: 6-hours post-intervention
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 and complex finger tapping task (SFTT & CFTT) performance
Time frame: 2-hours post-intervention
In this motor 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.
Change in Simple and complex finger tapping task (SFTT & CFTT) performance
Time frame: 4-hours post-intervention
In this motor 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.
Change in Simple and complex finger tapping task (SFTT & CFTT) performance
Time frame: 6-hours post-intervention
In this motor 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.
Change in the Task Switching Task (TST) performance
Time frame: 2-hours post-intervention
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 the Task Switching Task (TST) performance
Time frame: 4-hours post-intervention
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 the Task Switching Task (TST) performance
Time frame: 6-hours post-intervention
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 RAVLT - Delayed Word Recall performance
Time frame: 2-hours post-intervention
After a period of time subject are asked to recall as many words as possible from list A.
Change in RAVLT - Delayed Word Recall performance
Time frame: 4-hours post-intervention
After a period of time subject are asked to recall as many words as possible from list A.
Change in RAVLT - Delayed Word Recall performance
Time frame: 6-hours post-intervention
After a period of time subject are asked to recall as many words as possible from list A.
Change in RAVLT - Word Recognition performance
Time frame: 2-hours post-intervention
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 RAVLT - Word Recognition performance
Time frame: 4-hours post-intervention
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 RAVLT - Word Recognition performance
Time frame: 6-hours post-intervention
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.
10 secondary outcomes
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption
Time frame: Baseline
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption
Time frame: 2-hours post-intervention
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption
Time frame: 4-hours post-intervention
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption
Time frame: 6-hours post-intervention
Visual analogue measure of palatability of the intervention meal
Time frame: 1-hour post-intervention
Neurotrophic marker
Time frame: 6-hours post-intervention
Metabolic marker- Glucose
Time frame: 6-hours post-intervention
Metabolic marker- Insulin
Time frame: 6-hours post-intervention
Metabolic marker- Triglycerides
Time frame: 6-hours post-intervention
Inflammatory marker
Time frame: 6-hours post-intervention
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 23 May 2023.
- Background: PubMed 35115063Ba DM, Gao X, Al-Shaar L, Muscat J, Chinchilli VM, Ssentongo P, Beelman RB, Richie J. Mushroom intake and cognitive performance among US older adults: the National Health and Nutrition Examination Survey, 2011-2014. Br J Nutr. 2022 Dec 14;128(11):2241-2248. doi: 10.1017/S0007114521005195. Epub 2022 Feb 4.
- Background: PubMed 18579574Bingham S, Luben R, Welch A, Low YL, Khaw KT, Wareham N, Day N. Associations between dietary methods and biomarkers, and between fruits and vegetables and risk of ischaemic heart disease, in the EPIC Norfolk Cohort Study. Int J Epidemiol. 2008 Oct;37(5):978-87. doi: 10.1093/ije/dyn111. Epub 2008 Jun 25.
- Background: PubMed 33917843Gregory J, Vengalasetti YV, Bredesen DE, Rao RV. Neuroprotective Herbs for the Management of Alzheimer's Disease. Biomolecules. 2021 Apr 8;11(4):543. doi: 10.3390/biom11040543.
- Background: PubMed 26514091Rahman MA, Abdullah N, Aminudin N. Interpretation of mushroom as a common therapeutic agent for Alzheimer's disease and cardiovascular diseases. Crit Rev Biotechnol. 2016 Dec;36(6):1131-1142. doi: 10.3109/07388551.2015.1100585. Epub 2015 Oct 30.
- Background: PubMed 34798266Kleftaki SA, Simati S, Amerikanou C, Gioxari A, Tzavara C, Zervakis GI, Kalogeropoulos N, Kokkinos A, Kaliora AC. Pleurotus eryngii improves postprandial glycaemia, hunger and fullness perception, and enhances ghrelin suppression in people with metabolically unhealthy obesity. Pharmacol Res. 2022 Jan;175:105979. doi: 10.1016/j.phrs.2021.105979. Epub 2021 Nov 16.
- Background: PubMed 34505919Dicks L, Jakobs L, Sari M, Hambitzer R, Ludwig N, Simon MC, Stehle P, Stoffel-Wagner B, Helfrich HP, Ahlborn J, Ruhl M, Hartmann B, Holst JJ, Ellinger S. Fortifying a meal with oyster mushroom powder beneficially affects postprandial glucagon-like peptide-1, non-esterified free fatty acids and hunger sensation in adults with impaired glucose tolerance: a double-blind randomized controlled crossover trial. Eur J Nutr. 2022 Mar;61(2):687-701. doi: 10.1007/s00394-021-02674-1. Epub 2021 Sep 10.
- Individual participant dataSharing planned: No. All personally related collected information, including the paper consent forms, 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 (UREC). 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, so that they can be consulted and re-used by others.
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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 principal investigator
School of Psychology and Clinical Languages, 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 Instant noodle soup containing containing the equivalent of 2 servings (18.78g) of powdered Pleurotus oyster mushroom., Instant noodle soup containing containing the equivalent of 1 serving (9.39g) of powdered Pleurotus oyster mushroom. and Instant noodle soup containing containing the equivalent of 0.5 serving (4.70g) of powdered Pleurotus oyster mushroom. 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 8 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 23 May 2023. 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-SF) performance (time frame: 2-hours post-intervention). The study lists 21 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 NCT05594329, which also lists 6 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 23 May 2023.