PoZibio a Post-biotic Supplement on Cognitive Function and Brain Activity in Middle Age and Older Healthy Adults
Phase: EARLY_PHASE1
Conditions: Cognitive Decline
Sponsor: Aberystwyth University

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
 
Cover page with official title: A supplement on cognitive function and brain activity in middle age and 
older healthy adults (ID, INSERT) 
 
NCT number:  
 
Document date: 11 May 2023 
 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
Well-being and health Assessment 
Research Unit (WARU), 
Carwyn James Building, 
Aberystwyth University, 
Penglais, 
Aberystwyth, 
Ceredigion. 
SY23 3FD 
 
Date: 11 May 2023 
 
 
Table of Contents 
1) Introduction  
2) Statement of Purpose  
3) Investigational Product 
4) Investigational Product Safety 
5) Study Design 
6) Patient Risks 
7) Benefit To Subjects 
8) Privacy Confidentiality 
9) Safety Monitoring 
10) Data Analysis and Statistics 
11) References 
 
 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
 
1) Introduction 
Nowadays, the oral use of probiotics is widespread, in foods (i.e., yogurt), drinks (i.e., 
kombucha) and supplements. Heat-treated probiotics (essentially pasteurised or killed), cell-free 
supernatants, and purified key components can confer beneficial effects, mainly immune effects, 
protection against bacterial infections, and maintenance of gut health, which can positively 
impact on mental health and cognitive ability. Post-biotics, as they are called, have an advantage 
for food industry applications as they can easily be supplemented in several food lines/products 
and are shelf stable. PoZibioTM capsules contains the probiotics Lactobacillus paracasei which 
is a species of lactic acid bacteria often used in the fermentation of dairy products. It's found in 
the human intestinal tract and mouth, but also in foods such as yogurt and naturally fermented 
vegetables and milk. This has been heat-killed in PoZibioTM. 
Understanding whether cognition, in middle aged and older healthy adults, may be positively 
affected by the oral consumption of postbiotics, is important for helping us better understand the 
neuroprotective and enhancing properties of postbiotics and their future implementation into 
food and supplements. Electroencephalography (EEG) is a low cost, non-invasive method to 
record 
an electrogram of 
the 
spontaneous 
electrical 
activity 
of 
the brain. 
The bio 
signals detected by EEG have been shown to represent the postsynaptic potentials of pyramidal 
neurons in the neocortex and allocortex. It shall be combined with 3 psychological tasks (Stroop, 
Go/No-Go, and Flanker), to measure a variety of cognitive domains including attention, 
processing speed, accuracy, and response inhibition (Davidson et al., 2003; Feil et al., 2003; 
Redick et al., 2011). An eyes open/closed task will obtain baseline measurements for resting 
state. The Mini Mental State Exam (MMSE) questionnaire and geriatric depression scale (GDS) 
shall be used as screening tools to assess global cognitive function and depressive symptomology 
in participants prior to taking part. The EQ-5D questionnaire shall be used to obtain an overall 
profile of the health state and quality of life of participants. 
We will collect venous blood samples (3 x 4.5mL) for the investigation into the chemical 
composition using metabolomics at AberInnovation and Aberystwyth University, the 
quantification of short box chain fatty acids as well as clinical biochemistry (Chem21 to include 
lipid panel tests) at Bronglais hospital. 
 
2) Statement of Purpose 
A randomised, placebo controlled parallel human clinical trial of heat-treated Lactobacillus 
paracasei (post-biotics) in healthy middle aged and older subjects is proposed, to assess the 
potential for clinically relevant benefits in terms of cognitive function. We are aiming to recruit 
a cohort (n = 30) of middle aged and older adults (>50 years) who will be randomised into 
PoZibio™ (2 x capsules daily) or placebo (2 x capsules daily) supplementation for 6 weeks. 
Subjects will be asked to take both capsules in the morning with their breakfast. The placebo 
will be matched to the active product by taste and texture.  
 
 
3) Investigational Product 
 
3.1) 
Description 
The investigational product will contain a capsule with heat-treated Lactobacillus paracasei 
(inactivated cells count 50 billion counts (50 x 10^9 CFUs/ capsule)). The format will be a 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
167 mg capsule bottle containing 
60 capsules. Subjects will be asked to take 
the 2 capsules daily. The placebo will be matched to the active product by taste and texture.  
 
3.2) 
Quality 
This product is free of the following components and their products thereof: cereals 
containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk (including lactose), 
nuts, celery, mustard, sesame seeds, sulphur dioxide and sulphite, lupin and molluscs, in 
compliance with Regulation (EC) No. 1169/2011. This product does not contain added 
colorants. Cultures are Kosher, Halah approved. The supplements are vegan, and they are 
produced and stored in a food grade facility. The freeze-dried culture is packaged inside 
waterproof and airproof pouches, consisting of three layers (in order, going inwards): 
polyester, aluminium, and polyethylene. The packaging material used is food grade. 
 
3.3) 
Dose 
The dose of investigational product and placebo will be 2 x 1 ml capsules daily. 
 
4) Investigational Product Safety  
 
The species Lactobacillus paracasei is included in EFSA’s Quality Presumption of Safety 
(QPS) list. Total inactivated cells count > 1.5E+11 cells/g. The microbial strains are not 
genetically modified (GMO), in accordance to the European Directive 2001/18/EC. This 
product is not hazardous. Sacco S.r.l. is ISO 22000 and FSSC 22000 (food safety) 
certified since 2014. This product is considered safe with respect to bovine spongiform 
encephalopathy 
(BSE) 
or 
transmissible 
spongiform 
encephalopathies 
(TSEs) 
transmissions in accordance to Regulation EMA 410/01 rev. 3. 
 
5) Study Design 
5.1) 
Objectives of the Study 
5.1.1)  
Primary Outcome Measure: 
➢ Cognitive Control (Selective attention, processing speed, mental flexibility) 
Cognitive Control (Selective attention, processing speed, mental flexibility) measured using the 
Stroop task in E-Prime 
[Time Frame: Improved score (faster response time and improved accuracy) from baseline score at 
6 weeks after pozibio] 
 
➢ Cognitive Control (Selective attention, processing speed, mental flexibility) 
Cognitive Control (Selective attention, processing speed, mental flexibility) measured using the 
Stroop task in E-Prime 
[Time Frame: Improved score (faster response time and improved accuracy) at 6 weeks after 
pozibio when compared with placebo after 6 weeks] 
 
➢ Response inhibition (core construct in cognitive control and self-regulation) 
Measured using the Go/No-go task in E-Prime 
[Time Frame: Improved (fewer commission errors) score from baseline score at 6 weeks after 
pozibio] 
 
➢ Response inhibition (core construct in cognitive control and self-regulation) 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
Response inhibition (core construct in 
cognitive control and self-regulation) 
measured using the Go/No-go task in E-Prime 
[Time Frame: Improved (fewer commission errors ) score at 6 weeks after pozibio when compared 
with placebo after 6 weeks] 
 
➢ Selective attention and response inhibition (core constructs in cognitive control and self-
regulation) 
Selective attention and response inhibition (core constructs in cognitive control and self-regulation) 
measured using the Flanker task in E-Prime 
[Time Frame: Improved score (faster response time and improved accuracy) from baseline score at 
6 weeks after pozibio] 
 
➢ Selective attention and response inhibition (core constructs in cognitive control and self-
regulation) 
Selective attention and response inhibition (core constructs in cognitive control and self-regulation) 
measured using the Flanker task in E-Prime 
[Time Frame: Improved score (faster response time and improved accuracy) at 6 weeks after 
pozibio when compared with placebo after 6 weeks] 
 
➢ Electroencephalogram (EEG) during the Stroop task 
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the 
frontal and parietal regions 
[Time Frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components 
when compared with baseline] 
 
➢ Electroencephalogram (EEG) during the Stroop task 
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the 
frontal and parietal regions 
[Time Frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components 
when compared with 6 weeks of placebo] 
 
➢ Electroencephalogram (EEG) during the Flanker task 
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the 
frontal and parietal regions 
[Time Frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components 
when compared with baseline] 
 
➢ Electroencephalogram (EEG) during the Flanker task 
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the 
frontal and parietal regions 
[Time Frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components 
when compared with 6 weeks of placebo] 
 
➢ Electroencephalogram (EEG) during the go/no-go task 
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the 
frontal and parietal regions 
[Time Frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components 
when compared with baseline] 
 
➢ Electroencephalogram (EEG) during the go/no-go task 
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the 
frontal and parietal regions 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
[Time Frame: After 6 weeks of pozibio, 
no delay of the P3 component and more N2 
components when compared with 6 weeks of placebo] 
 
➢ Electroencephalogram (EEG) during the stroop, Flanker and go/no-go tasks 
Assessing alpha and delta activity 
[Time Frame: After 6 weeks of pozibio, increased alpha and delta activity when compared with 
baseline] 
 
➢ Electroencephalogram (EEG) during the stroop, Flanker and go/no-go tasks 
Assessing alpha and delta activity 
[Time Frame: After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 
weeks of placebo] 
 
➢ EuroQol 5 Dimension 5L 
EuroQol 5 Dimension 5 5L questionnaire: Generic quality of life. Mobility- Level 1-5 Self-Care- 
Level 1-5, Usual Activities- Level 1-5, Pain/Discomfort- Level 1-5, Anxiety/Depression- Level 1-5, 
EQ-VAS: Numerical value between 0-100 representing how the patient perceives their overall 
health to be. 
[Time Frame: Reduced score from baseline EuroQol 5 Dimension 5 score at 6 weeks after pozibio] 
 
➢ EuroQol 5 Dimension 5L 
EuroQol 5 Dimension 5 5L questionnaire: Generic quality of life. Mobility- Level 1-5 Self-Care- 
Level 1-5, Usual Activities- Level 1-5, Pain/Discomfort- Level 1-5, Anxiety/Depression- Level 1-5, 
EQ-VAS: Numerical value between 0-100 representing how the patient perceives their overall 
health to be. 
[Time Frame: Reduced EuroQol 5 Dimension 5 score at 6 weeks after pozibio when compared with 
placebo after 6 weeks] 
 
5.1.2) Secondary Outcome Measures: 
 
➢ C-reactive protein 
C-reactive protein in plasma as a marker of inflammation 
[Time Frame: Reduced C-reactive protein from baseline at 6 weeks after pozibio] 
 
➢ C-reactive protein 
C-reactive protein in plasma as a marker of inflammation 
[Time Frame: Reduced C-reactive protein at 6 weeks after pozibio when compared with placebo 
after 6 weeks] 
 
➢ Kidney function tests 
 
Kidney function tests including sodium/potassium/creatinine/urea 
[Time Frame: Reduced Kidney function tests from baseline at 6 weeks after pozibio] 
 
➢ Kidney function tests 
Kidney function tests including sodium/potassium/creatinine/urea 
[Time Frame: Reduced Kidney function tests at 6 weeks after pozibio when compared with placebo 
after 6 weeks] 
 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
➢ Total Cholesterol 
Total Cholesterol 
[Time Frame: Reduced total Cholesterol from baseline at 6 weeks after pozibio] 
 
➢ Total Cholesterol 
Total Cholesterol 
[Time Frame: Reduced total Cholesterol at 6 weeks after pozibio when compared with placebo after 
6 weeks] 
 
➢ Total Triglyceride 
Total Triglyceride 
[Time Frame: Reduced total Triglyceride from baseline at 6 weeks after pozibio] 
 
➢ Total Triglyceride 
Total Triglyceride 
[Time Frame: Reduced total Triglyceride at 6 weeks after pozibio when compared with placebo 
after 6 weeks] 
 
➢ Liver function tests (LFTs) 
Aspartate aminotransferase (AST), Alanine transaminase (ALT), Alkaline phosphatase (ALP), 
Gamma-glutamyltransferase (GGT), Prothrombin time (PT), Albumin, 
[Time Frame: Reduced Liver function test from baseline at 6 weeks after pozibio] 
 
➢ Liver function tests (LFTs) 
Aspartate aminotransferase (AST), Alanine transaminase (ALT), Alkaline phosphatase (ALP), 
Gamma-glutamyltransferase (GGT), Prothrombin time (PT), Albumin, 
[Time Frame: Reduced Liver function test results at 6 weeks after pozibio when compared with 
placebo after 6 weeks] 
 
➢ Changes in short chain fatty acids concentrations in plasma 
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-
Flame Ionization Detection 
[Time Frame: Increased concentration of total short chain fatty acids after the pozibio at 6 weeks 
compared with the baseline] 
 
➢ Changes in short chain fatty acids concentrations in plasma 
Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-
Flame Ionization Detection 
[Time Frame: Increased concentration of total short chain fatty acids after the pozibio at 6 weeks 
compared with that after placebo at 6 weeks] 
 
 
5.2) 
Subject Selection 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
- 
30 participants, over 50 
years, mixed gender, mixed ethnicity. 
 
- 
Inclusion Criteria: 
➢ Subjects over 50 years of age. 
➢ Subjects with Mini-Mental State Exam (MMSE) of 25-30 inclusive (global 
cognitive function).Subjects who are able to undergo EEG and to commit to 
visits to WARU/P5. 
➢ Subjects who are able to provide venous blood samples. 
➢ Subjects able to provide written informed consent PRIOR to performing any 
study procedures. 
 
- 
Exclusion Criteria: 
➢ Subjects with diagnosis of Alzheimer’s disease or other dementia. 
➢ Subjects taking medication for the treatment of dementia (such as 
acetylcholinesterase inhibitors (Aricept, Excelon), memantine (Namenda) or 
other medications with similar mechanisms of action) or medical foods (such 
as Cerefolin, Souvenaid, Axona) for the treatment of dementia. 
➢ Subjects who are already regularly taking probiotics, post-biotics, 
nutraceutical and/or vitamin supplements related to PoZibio ™ within 30 days 
of screening. 
➢ Subjects with Geriatric Depression Scale > 6. 
➢ Subjects with a Mini Mental State Exam score below 25. 
➢ Subjects who are pregnant or lactating. 
➢ Subjects with medical condition or disease that is life threatening. 
➢ Subjects who smoke cigarettes or use other products containing nicotine. 
➢ Subjects diagnosed with diabetes. 
➢ Subjects taking warfarin. 
➢ Subjects who have a diagnosed or suspected mental health condition, or who 
have any concerns surrounding their mental health. 
➢ Subjects who have immediate family members with diagnosed mental health 
condition or suspected mental health concerns. 
 
- 
Covid Exclusion criteria  
➢ Showing (or anyone within the household) any COVID-19 symptoms (see 
COVID-19 basic health screen)* 
➢ Higher risk or vulnerable from coronavirus or live with someone at a higher 
risk of a severe illness from COVID-19 (over 70, undergoing cancer 
treatment, high risk of getting infections). 
➢ Had a letter from the NHS advising you to shield (isolate). 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
➢ Had been at risk 
of exposure to COVID-19 such as travel, 
contact with someone with COVID-19, been exposed to the virus, or has 
been asked to self-isolate by the track and trace system. 
➢ Serious health conditions that require daily long-term medication.  
 
*If the potential participant has had COVID-19 previously (and are fully recovered and not within 
isolation) then they are eligible to join the study. 
 
 
5.3) 
Study Design 
This is a randomised, placebo controlled, parallel study, where participants are asked to take 
the capsules (PoZibioTM or Placebo) twice a day for a period of 6 weeks. Participants will be 
required to make five visits to the Well-being and Health Assessment Research Unit (WARU) 
and Psychology department at Aberystwyth University; however, several visits can be 
combined if needed. EEG data analysis will be conducted at Aberystwyth University. 
Chemical composition using metabolomics will be conducted at AberInnovation and 
Aberystwyth University, and the quantification of short chain fatty acids as well as clinical 
biochemistry (Chem21 to include lipid panel tests) will be analysed at Bronglais hospital.  
 
 
Pre-Induction 
 
Participants are welcomed with tea or coffee and talked through how safe working 
practices are being conducted during coronavirus (COVID-19). Participants are informed 
that they will be completing the Mini Mental State Exam (MMSE) to assess their overall 
cognitive function, and the Geriatric Depression Scale (GDS) to assess for any depressive 
symptomatology, as part of the screening process. They are reminded that these screening 
questionnaires are not diagnostic and are not intended for clinical assessment purposes; 
instead, they are to ensure consistency across the participant sample, whereby the 
inclusion and exclusion scores are taken from pre-existing literature. Participants are 
informed that the MMSE should take approximately 10 minutes to complete, and the GDS 
will take approximately 5 minutes to complete, and that they will be told their scores after 
they have completed both questionnaires. If they meet the:  
- 
Inclusion Criteria:  
Their scores will be retained, but their name will be pseudonymised using their 
randomised, unique code, and only the researchers closely affiliated with the project 
will have access to their data  
- 
Exclusion criteria:  
They will no longer be able to continue with the study, their data will be deleted, and 
they shall be provided a participant exclusion form with what to do next. 
 
Participants are provided with the chance to ask any questions. If they are happy to 
continue, they are asked to read and sign the consent form. After screening ends, 
participants are offered water and the opportunity to use the bathroom whilst their scores 
are calculated.  
 
If they meet the inclusion criteria, then: 
- 
A record of their scores is retained in an excel spreadsheet next to their anonymous ID 
code. 
- 
They are informed that they have met the inclusion criteria. 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
- 
They are thanked for their 
time and walked to the door. 
If they do not meet the inclusion criteria, then:   
- 
A note of their scores is made in the participant exclusion feedback form identifying 
which (or both) of the exclusion criteria they met.  
- 
The participant is talked through the participant exclusion feedback form and provided 
with the chance to ask questions.  
 
- 
They are thanked for their time, and if they are happy to leave, then they are walked 
to the door.  
- 
Their personal data is deleted in compliance with GDPR. 
 
 
Testing day 1  
Participants arrive at WARU on their pre-organised day and time after a 12 hour fast for 
a venous blood draw (3 tubes), followed by tea and toast. They are asked to complete an 
EQ-5D (5L) questionnaire. Their height and weight, waist, and hip circumference are 
measured. They are then free to leave, unless they have chosen to combine testing day 1 
and 2 together, in which case they are guided to the P5 building where the activities 
outlined under testing day 2 commence.  
 
Testing day 2 (can be combined with day 1 if needed) 
If participants opt not to combine testing days 1 and 2 together, then they are met at the 
main reception and guided to the P5 building, where they are encouraged to go to the toilet 
prior to testing. They are then taken to P4, where the EEG laboratory is located. They shall 
then undergo their first EEG and cognitive assessment. They are first asked to participate 
in an eyes open/closed task for measurements of their EEG resting state. Following this, 
three cognitive tasks (the Stroop task, the Go/No-go task, and the Flanker task) are 
digitally completed in a computer program called E-Prime.  Practice rounds are provided 
for each task, with the researcher present, to allow for any questions before each 
experiment begins. After each task, the EEG program is stopped, and a new data file is 
created, before recording for the following task takes place. This provides an opportunity 
in between tasks for a sip of water, or a toilet break, if necessary, although the EEG cap 
must remain in place, and the nearest accessible toilets are in P5. Altogether, the tasks 
shall take approximately 60-70 minutes to complete, with an additional 45 minutes 
allocated for the application of the EEG cap.  Participants are encouraged to bring their 
own bottled drinks, and snacks are made available. They are also granted access to the 
‘break out’ room on the second floor of P5, prior to and following their participation, 
where there are chairs and tea/coffee machines available. Following their participation, 
participants are re-directed back to WARU for the collection of their capsules. Participants 
are reminded before taking part that they will not receive any scores post EEG testing, 
indicating how well they performed, but that the overall general findings of the study can 
be made available to them, following the end of the study, by contacting 
WARU@aber.ac.uk. 
 
Testing day 3 
 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
After 
the 
6-week 
supplementation period, participants are 
asked to complete the activities that they undertook during testing day 2. A staff member 
is told to meet the participant in the P5 lobby to walk them over to P4. This is the final 
assessment of EEG and cognitive testing. If participants decide to combine testing 
days 3 and 4 together, then a staff member is made available to walk participants 
down to WARU.  
 
Note: All participants are encouraged to try to combine testing days 3 and 4 together (if possible), 
to ensure that cognitive testing and the venous blood draw occur within the same 48-hour 
window to when the last capsules of the 6-week trial are taken.   
 
 
Testing day 4 (can be combined with day 3 if needed) 
Within 48 hours after testing day 3, still following the supplementation regime, 
participants are invited to WARU after a 12 hour fast for their final venous blood draw (3 
tubes), followed by tea and toast. They are then asked to digitally complete the EQ-5D 
(5L) and MMSE questionnaires. Their height and weight, waist, and hip circumference 
measurements are taken. There is an optional feedback questionnaire at the end. 
 
6) Participant Risks 
The supplements have already been tested for any adverse effects in a human cohort, however 
if any negative effects occur, participants are asked to refrain from continuing in the study.  
 
EEG is non-invasive, however placing the EEG electrodes along the scalp can be time 
consuming (approximately 45 minutes), and participants are required to sit relatively still 
during the application and testing process (the application and testing process combined take 
approximately 2 hours). The application of the EEG cap requires EEG gel (saline solution) to 
be applied to the scalp, which makes hair messy upon removal of the cap. Participants are 
informed that towels will be placed along their shoulders to avoid the solution meeting their 
clothes, and these towels (in addition to paper towels) are provided to remove any excess gel 
from their hair. Participants are reminded that hair washing facilities are available in P5 for 
them to use, but that this would require a short walk from P4 back to P5. Therefore, 
participants are advised to bring a hat to cover their head for their own comfort. Participants 
are also reminded that venous blood draws can also cause localised soreness, stress, and 
dizziness.  
 
7) Benefits to participant 
 
There is no financial gain for participants if they decide to join this study. They will allow us 
to gain important insight into the PoZibio TM supplement to improve cognitive performance 
in healthy volunteers, which may be applied to other cohorts such as those suffering from 
vascular dementia and Alzheimer’s disease.  
 
8) Privacy/confidentiality 
 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
Participants are informed that 
only the researchers involved with the study 
will be able to look at the information they provide. Specific details and personal identifiers 
will only be available to the researchers.  At the end of the study, any information relating to 
participants will be made pseudonymous (coded without their name associated).  Participants 
will not be identifiable in any publication that may arise from this research. Electronic files 
will be kept in a logical manner and will always be kept grouped within specific folders and 
password-protected. 
 
protected. Files are backed up and all data storage is using the AU network. Once the raw data 
has been extracted from a paper version onto a computer, the paper will be destroyed via a 
paper shredder or in confidential waste bags to ensure the participant’s confidentiality. There 
may be times when keeping paper forms are necessary (consent forms), but in this case the 
paper versions will be kept in a locked filing cabinet. All files that are stored on the WARU 
share drive will always be protected with a secure password. Setting passwords will 
automatically encrypt the document and will not allow any unauthorised access to the data. 
The Gatekeeper of the passwords delivers the passwords by encrypted emails. All biofluids 
are stored in a locked freezer. Key is kept by the gatekeeper. EEG recordings will be stored 
on a password protected PC in the EEG lab. Due to the nature of the datafiles and the location 
of the software, it is not possible to store these files in a password protected folder on 
OneDrive. The lab PC is password-protected, files are stored under random codes and the PC 
itself is not connected to any network or the internet.  EEG recordings will be removed (by 
deletion) from the lab PC after five years but may be removed sooner due to disk space 
issues.  Only authorised staff members have access to the EEG lab, and the key for the storage 
cupboard affiliated with the EEG lab is stored within the locked EEG lab.  
 
9) Safety Monitoring 
- 
Participant: 
If a participant, or a member of their family/household become unwell during the 
study, then they are pre-warned to alert a member of the research team immediately 
using the contact information they have been provided. Participation in the study will 
be suspended immediately until further discussion with the research team has taken 
place. If they become unwell at any point and need medical assistance, they are 
advised to contact 111 and seek advice from the NHS health sector or their doctor’s 
surgery. We have a duty of care towards them and can help monitor their health 
remotely over 14 days and will help in any way we can.  
- 
Data:  
As above 
 
10) Data analysis and statistics 
 
EEG data analysis will be conducted at Aberystwyth University. Chemical composition using 
metabolomics will be conducted at AberInnovation and Aberystwyth University, and the 
quantification of short chain fatty acids as well as clinical biochemistry (Chem21 to include 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
lipid panel tests) will be analysed 
at Bronglais hospital. Statistics will be 
conducted by the Aberystwyth University researchers.