Cognitive, Mood, Anti-Inflammatory and Metabolic Effects of Chronic Oyster Mushroom Intervention in Older Adults

NCT06846827 | Completed

• 1 other identifier: 2023-088-CW
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Change; Mood; Metabolism; Inflammatory Response; Weight Change

Keywords

Episodic memory; Executive function; Working memory; Attention; Motor function; Mood; Metabolism; Inflammation

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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".

  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.

  Baseline and 12-weeks

Secondary Outcomes (10)

• 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

Other Outcomes (4)

• Health and Lifestyle Questionnaire

  Baseline

• Epic-Norfolk Food Frequency Questionnaire (FFQ)

  Baseline

• Epic-Norfolk Food Frequency Questionnaire (FFQ)

  12-weeks

Study Arms (2)

Oyster mushroom

EXPERIMENTAL

dried oyster mushrooms

Other: Oyster mushroom

Placebo

PLACEBO COMPARATOR

maltodextrin

Other: Maltodextrin

Interventions

Oyster mushroom OTHER

Sachet containing the equivalent of 1 serving (9.39g) of dried ergothioneine-rich Pleurotus oyster mushrooms

Oyster mushroom

Maltodextrin OTHER

Sachet containing 6.67g of maltodextrin

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 60-80 years old
• Have normal vision and hearing
• Have a Body mass index (BMI\<=30)
• Have healthy status

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Reading: lead
• Mushroom Council: collaborator

Study Sites (1)

University of Reading

Reading, RG2 9AH, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 32581767 BACKGROUND

• Mori 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.

  PMID: 18844328 BACKGROUND

• Saitsu 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.

  PMID: 31413233 BACKGROUND

• Tsuk 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.

  PMID: 29199566 BACKGROUND

• Wang 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.

  PMID: 29742702 BACKGROUND

• Zajac 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.

  PMID: 33339304 BACKGROUND

• Grozier 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.

  PMID: 36582308 BACKGROUND

MeSH Terms

Conditions

Body Weight Changes; Inflammation

Interventions

pleurotolysin B, oyster mushroom; maltodextrin

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Claire M Williams

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neuroscience

Model Details: Between- and within-groups (mixed) model

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 26, 2025
• Study Start: October 1, 2023
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)