A Randomised Controlled Trial to Investigate the Cognitive, Mood, Anti-inflammatory and Metabolic Effects of Chronic Oyster Mushroom Intervention in Older Adults (OYSCOG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Positive and Negative Affect Schedule (PANAS-X) performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 60-80 years old
- •Have normal vision and hearing
- •Have a Body mass index (BMI<=30)
- •Have healthy status
排除标准
- •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
- •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
研究组 & 干预措施
Placebo
maltodextrin
干预措施: Maltodextrin (Other)
Oyster mushroom
dried oyster mushrooms
干预措施: Oyster mushroom (Other)
结局指标
主要结局
Change in Positive and Negative Affect Schedule (PANAS-X) performance
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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 Complex Finger Tapping Task (CFTT) performance
时间窗: Baseline and 12-weeks
In this motor function task, participants tap a specific sequence using 4 fingers, for 1 minute.
Change in Simple Finger Tapping Task (SFTT) performance
时间窗: 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 RAVLT - Delayed Word Recall performance
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Systolic Blood Pressure(Baseline and 12-weeks)
- Change in Diastolic Blood Pressure(Baseline and 12-weeks)
- Change in Heart Rate(Baseline and 12-weeks)
- Change in Body Mass Index (BMI)(Baseline and 12-weeks)
- Change in neurotrophic marker(Baseline and 12-weeks)
- Change in metabolic markers(Baseline and 12-weeks)
- Change in inflammatory markers(Baseline and 12-weeks)
- Change in P300(Baseline and 12-weeks)
- Change in N200(Baseline and 12-weeks)
- Change in Power Spectral Density (PSD)(Baseline and 12-weeks)
研究者
Prof Claire Williams
Professor of Neuroscience
University of Reading