An Early Phase 1 interventional study of PoZibio and Placebo in Cognitive Decline, sponsored by Aberystwyth University. Status unknown at 1 site in United Kingdom. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Aberystwyth University · Early Phase 1, Interventional, and Supportive care
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.
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 40 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Aberystwyth University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PoZibio, twice daily (50 x 10\^9 CFUs/ CAPSULE) for 6 weeks
Dietary Supplement: PoZibio
Placebo, twice daily for 6 weeks
Dietary Supplement: Placebo
PoZibio (50 x 10\^9 CFUs/ CAPSULE)
Placebo
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)
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
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 task
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 Flanker task
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 go/no-go task
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 task
Assessing alpha and delta activity
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Reduced EuroQol 5 Dimension 5 score 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
Plan to share: No — No plan to make individual participant data (IPD) available to other researchers
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Aberystwyth University