Neurological, Inflammatory and Metabolic Effects of Acute Mushroom Intervention in Older Adults

NCT05594329 | Completed

• 1 other identifier: 22/10
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Change; Mood; Metabolism; Inflammatory Response; Satiety

Keywords

Cognition; Mood; Inflammation; Metabolism

Outcome Measures

Primary Outcomes (21)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6-hours post-intervention

Secondary Outcomes (10)

• Visual analogue measure of hunger, satiety, fullness, and prospective food consumption

  Baseline

• Visual analogue measure of hunger, satiety, fullness, and prospective food consumption

  2-hours post-intervention

• Visual analogue measure of hunger, satiety, fullness, and prospective food consumption

  4-hours post-intervention

• Visual analogue measure of hunger, satiety, fullness, and prospective food consumption

  6-hours post-intervention

• Visual analogue measure of palatability of the intervention meal

  1-hour post-intervention

Other Outcomes (3)

• Health and Lifestyle Questionnaire

  Baseline

• Epic-Norfolk Food Frequency Questionnaire (FFQ)

  Baseline

• Specialised dietary survey

  6-hours post-intervention on final test day

Study Arms (4)

Experimental meal 1

EXPERIMENTAL

Instant noodle soup containing 2 servings of dried Pleurotus oyster mushroom.

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.

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.

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.

Other: Control instant noodle soup

Interventions

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.

Experimental meal 1

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.

Experimental meal 2

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.

Experimental meal 3

Control instant noodle soup OTHER

Ingredients: cornflour, celery, garlic, ginger, gluten, polyphosphate, parsley, pepper, potassium carbonates, maltodextrin, salt, sodium, sunflower oil, turmeric, yeast extract and wheat flour.

Control meal

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 healthy status
• Have a BMI\<30

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Mushroom Council: collaborator

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 35115063 BACKGROUND

• Bingham 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.

  PMID: 18579574 BACKGROUND

• Gregory 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.

  PMID: 33917843 BACKGROUND

• Rahman 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.

  PMID: 26514091 BACKGROUND

• Kleftaki 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.

  PMID: 34798266 BACKGROUND

• Dicks 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.

  PMID: 34505919 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire Williams, PhD

  School of Psychology and Clinical Languages, University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 26, 2022
• Study Start: August 15, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 22, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)