Cognitive DeclineEarly Phase 1PZACNCT05892627
A Supplement on Cognitive Function and Brain Activity in Middle Age and Older Healthy Adults
A Early Phase 1 study testing PoZibio in people with Cognitive Decline, run by Aberystwyth University at 1 site in United Kingdom.
Trial summary
PoZibio™ capsules contains Lactobacillus paracasei which has been heat-killed (post-biotic). The researchers will recruit a cohort 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- PoZibio
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2023to 31 Dec 2023
- Phase
- Early Phase 1
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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 identify as being vegetarian or vegan
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Well-being and Health Assessment Research Unit (WARU)
Aberystwyth, Ceredigion, SY23 3FD
Amanda J Lloyd, PhD, BSc, 07811618109, abl@aber.ac.uk
Alina Warren, MSc, BSc, 07539440811, arw21@aber.ac.uk
About this study
Official title: PoZibio a Post-biotic Supplement on Cognitive Function and Brain Activity in Middle Age and Older Healthy Adults
PoZibio™ capsules contains Lactobacillus paracasei which has been heat-killed (post-biotic).
The researchers will recruit a cohort 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.
Read more
Electroencephalography (EEG) shall be combined with 3 psychological tasks, to measure a variety of cognitive domains including attention, processing speed, accuracy, and response inhibition. These psychological tasks shall include the Stroop task, the Go/No-go task, and the Flanker task. Before taking part in the psychological tasks, participants shall be required to have their EEG resting state recorded, requiring them to participate in an Eyes Open/Closed Task.
The Mini Mental State Exam (MMSE) questionnaire shall be used as a digital screening tool to assess global cognitive function in participants both prior to and following the 6-week PoZibio trial. The geriatric depression scale (GDS) shall also be used as a digital screening tool to assess for depressive symptomatology in older adults. The EQ-5D questionnaire shall be used to obtain an overall profile of the health state and quality of life of participants before and after the trial.
The researchers will collect venous blood samples for the investigation into the chemical composition using metabolomics, the quantification of short chain fatty acids as well as clinical biochemistry, before and after the trial.
Aim:
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.
Read the detailed description
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. Postbiotics, 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. PoZibio™ 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 PoZibio™(post biotic).
The researchers are aiming to recruit a cohort 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.
Electroencephalography (EEG) shall be combined with 3 psychological tasks in a computer program called E-Prime, to measure a variety of cognitive domains including attention, processing speed, accuracy, and response inhibition. These psychological tasks shall include the Stroop task, the Go/No-go task, and the Flanker task. Before taking part in the psychological tasks, participants shall be required to have their EEG resting state recorded, requiring them to participate in an Eyes Open/Closed Task.
The Mini Mental State Exam (MMSE) questionnaire shall be used as a digital screening tool to assess global cognitive function in participants both prior to and following the 6-week PoZibio™ trial. The geriatric depression scale (GDS) shall also be used as a digital screening tool to assess for depressive symptomatology in older adults. The EQ-5D questionnaire shall be used to obtain an overall profile of the health state and quality of life of participants, before and after the trial.
The researchers will collect venous blood samples for the investigation into the chemical composition using metabolomics, the quantification of short chain fatty acids as well as clinical biochemistry, before and after the trial.
Aim:
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.
- Conditions
- Cognitive Decline
- Being tested
- PoZibio, Placebo
- Keywords
- Electroencephalography, Post-biotic, Lactobacillus paracasei, Cognitive health, Mental function, Metabolomics
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoZibioDietary supplement
PoZibio (50 x 10^9 CFUs/ CAPSULE)
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PoZibio | Experimental | PoZibio, twice daily (50 x 10^9 CFUs/ CAPSULE) for 6 weeks Receives: Dietary Supplement: PoZibio |
| Placebo | Placebo comparator | Placebo, twice daily for 6 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Control (Selective attention, processing speed, mental flexibility)
Cognitive Control (Selective attention, processing speed, mental flexibility) measured using the Stroop task in E-Prime
Measured: 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
Measured: 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
Measured: Improved (fewer commission errors) score from baseline score at 6 weeks after pozibio
Response inhibition (core construct in cognitive control and self-regulation)
Response inhibition (core construct in cognitive control and self-regulation) measured using the Go/No-go task in E-Prime
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 task
Assessing alpha and delta activity
Measured: After 6 weeks of pozibio, increased alpha and delta activity when compared with baseline
Electroencephalogram (EEG) during the Flanker task
Assessing alpha and delta activity
Measured: After 6 weeks of pozibio, increased alpha and delta activity when compared with baseline
Electroencephalogram (EEG) during the go/no-go task
Assessing alpha and delta activity
Measured: After 6 weeks of pozibio, increased alpha and delta activity when compared with baseline
Electroencephalogram (EEG) during the stroop task
Assessing alpha and delta activity
Measured: After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 weeks of placebo
Electroencephalogram (EEG) during the Flanker task
Assessing alpha and delta activity
Measured: After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 weeks of placebo
Electroencephalogram (EEG) during the go/no-go task
Assessing alpha and delta activity
Measured: After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 weeks of placebo
EuroQol 5 Dimension 5L (combined score)
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. The digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state.
Measured: Reduced score from baseline EuroQol 5 Dimension 5 score at 6 weeks after pozibio
EuroQol 5 Dimension 5L (combined score)
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. The digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state.
Measured: Reduced EuroQol 5 Dimension 5 score at 6 weeks after pozibio when compared with placebo after 6 weeks
Secondary outcomes (2)
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
Measured: 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
Measured: Increased concentration of total short chain fatty acids after the pozibio at 6 weeks compared with that after placebo at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cohort who will be randomised into PoZibio™ (2 x capsules daily) or placebo (2 x capsules daily) supplementation for 6 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aberystwyth University
- Sponsor type
- University, hospital or other
- Collaborators
- AGROCEUTICAL PRODUCTS LTD, Neurodyn Life Sciences Inc., Postbiotics Inc, Welsh Government
- Responsible party
- Sponsor
- Investigators
- Amanda J Lloyd, PhD, BSc, Principal investigator, Aberystwyth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892627
- Sponsor's protocol ID
- 23766
- Acronym
- PZAC
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PoZibio a Post-biotic Supplement on Cognitive Function and Brain Activity in Middle Age and Older Healthy Adults
- ClinicalTrials.gov ID
- NCT05892627
- Acronym / sponsor ID
- PZAC / 23766
- Conditions
- Cognitive Decline
- Keywords
- Electroencephalography, Post-biotic, Lactobacillus paracasei, Cognitive health, Mental function, Metabolomics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aberystwyth UniversityUniversity, hospital or other
- Collaborators
- AGROCEUTICAL PRODUCTS LTD, Neurodyn Life Sciences Inc., Postbiotics Inc, Welsh Government
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Jun 2023 (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.
PoZibio™ capsules contains Lactobacillus paracasei which has been heat-killed (post-biotic).
The researchers will recruit a cohort 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.
Electroencephalography (EEG) shall be combined with 3 psychological tasks, to measure a variety of cognitive domains including attention, processing speed, accuracy, and response inhibition. These psychological tasks shall include the Stroop task, the Go/No-go task, and the Flanker task. Before taking part in the psychological tasks, participants shall be required to have their EEG resting state recorded, requiring them to participate in an Eyes Open/Closed Task.
The Mini Mental State Exam (MMSE) questionnaire shall be used as a digital screening tool to assess global cognitive function in participants both prior to and following the 6-week PoZibio trial. The geriatric depression scale (GDS) shall also be used as a digital screening tool to assess for depressive symptomatology in older adults. The EQ-5D questionnaire shall be used to obtain an overall profile of the health state and quality of life of participants before and after the trial.
The researchers will collect venous blood samples for the investigation into the chemical composition using metabolomics, the quantification of short chain fatty acids as well as clinical biochemistry, before and after the trial.
Aim:
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.
Detailed description
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. Postbiotics, 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. PoZibio™ 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 PoZibio™(post biotic).
The researchers are aiming to recruit a cohort 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.
Electroencephalography (EEG) shall be combined with 3 psychological tasks in a computer program called E-Prime, to measure a variety of cognitive domains including attention, processing speed, accuracy, and response inhibition. These psychological tasks shall include the Stroop task, the Go/No-go task, and the Flanker task. Before taking part in the psychological tasks, participants shall be required to have their EEG resting state recorded, requiring them to participate in an Eyes Open/Closed Task.
The Mini Mental State Exam (MMSE) questionnaire shall be used as a digital screening tool to assess global cognitive function in participants both prior to and following the 6-week PoZibio™ trial. The geriatric depression scale (GDS) shall also be used as a digital screening tool to assess for depressive symptomatology in older adults. The EQ-5D questionnaire shall be used to obtain an overall profile of the health state and quality of life of participants, before and after the trial.
The researchers will collect venous blood samples for the investigation into the chemical composition using metabolomics, the quantification of short chain fatty acids as well as clinical biochemistry, before and after the trial.
Aim:
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A cohort who will be randomised into PoZibio™ (2 x capsules daily) or placebo (2 x capsules daily) supplementation for 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| PoZibio | Experimental | Dietary Supplement: PoZibioPoZibio, twice daily (50 x 10^9 CFUs/ CAPSULE) for 6 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo, twice daily for 6 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| PoZibioPoZibio (50 x 10^9 CFUs/ CAPSULE) | Dietary supplement | PoZibio |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Cognitive Control (Selective attention, processing speed, mental flexibility)
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) measured using the Stroop task in E-Prime
Cognitive Control (Selective attention, processing speed, mental flexibility)
Time frame: Improved score (faster response time and improved accuracy) at 6 weeks after pozibio when compared with placebo after 6 weeks
Cognitive Control (Selective attention, processing speed, mental flexibility) measured using the Stroop task in E-Prime
Response inhibition (core construct in cognitive control and self-regulation)
Time frame: Improved (fewer commission errors) score from baseline score at 6 weeks after pozibio
Measured using the Go/No-go task in E-Prime
Response inhibition (core construct in cognitive control and self-regulation)
Time frame: Improved (fewer commission errors ) score 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
Selective attention and response inhibition (core constructs in cognitive control and self-regulation)
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) measured using the Flanker task in E-Prime
Selective attention and response inhibition (core constructs in cognitive control and self-regulation)
Time frame: Improved score (faster response time and improved accuracy) 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) measured using the Flanker task in E-Prime
Electroencephalogram (EEG) during the Stroop task
Time frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with baseline
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions
Electroencephalogram (EEG) during the Stroop task
Time frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with 6 weeks of placebo
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions
Electroencephalogram (EEG) during the Flanker task
Time frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with baseline
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions
Electroencephalogram (EEG) during the Flanker task
Time frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with 6 weeks of placebo
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions
Electroencephalogram (EEG) during the go/no-go task
Time frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with baseline
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions
Electroencephalogram (EEG) during the go/no-go task
Time frame: After 6 weeks of pozibio, no delay of the P3 component and more N2 components when compared with 6 weeks of placebo
Assessing event related potentials (ERP's) in the P3 component and the N2 component across the frontal and parietal regions
Electroencephalogram (EEG) during the stroop task
Time frame: After 6 weeks of pozibio, increased alpha and delta activity when compared with baseline
Assessing alpha and delta activity
Electroencephalogram (EEG) during the Flanker task
Time frame: After 6 weeks of pozibio, increased alpha and delta activity when compared with baseline
Assessing alpha and delta activity
Electroencephalogram (EEG) during the go/no-go task
Time frame: After 6 weeks of pozibio, increased alpha and delta activity when compared with baseline
Assessing alpha and delta activity
Electroencephalogram (EEG) during the stroop task
Time frame: After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 weeks of placebo
Assessing alpha and delta activity
Electroencephalogram (EEG) during the Flanker task
Time frame: After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 weeks of placebo
Assessing alpha and delta activity
Electroencephalogram (EEG) during the go/no-go task
Time frame: After 6 weeks of pozibio, increased alpha and delta activity when compared with 6 weeks of placebo
Assessing alpha and delta activity
EuroQol 5 Dimension 5L (combined score)
Time frame: Reduced score from baseline EuroQol 5 Dimension 5 score at 6 weeks after pozibio
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. The digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state.
EuroQol 5 Dimension 5L (combined score)
Time frame: Reduced EuroQol 5 Dimension 5 score at 6 weeks after pozibio when compared with placebo after 6 weeks
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. The digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state.
2 secondary outcomes
Changes in short chain fatty acids concentrations in plasma
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
Time frame: Increased concentration of total short chain fatty acids after the pozibio at 6 weeks compared with that after placebo at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers
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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.
Amanda J Lloyd, PhD, BSc principal investigator
Aberystwyth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PoZibio in people with Cognitive Decline, run by Aberystwyth University 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 7 Jun 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda J Lloyd, PhD, BSc (07811618109, abl@aber.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Control (Selective attention, processing speed, mental flexibility) (time frame: Improved score (faster response time and improved accuracy) from baseline score at 6 weeks after pozibio). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.