Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892627
Status:
RECRUITING
Last Update Posted:
2023-06-07
First Post:
2023-04-28
Brief Title:
A Supplement on Cognitive Function and Brain Activity in Middle Age and Older Healthy Adults
Sponsor:
Aberystwyth University
Organization:
Aberystwyth University
Study Overview
Official Title:
PoZibio a Post-biotic Supplement on Cognitive Function and Brain Activity in Middle Age and Older Healthy Adults
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PZAC
Brief 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 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 GoNo-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 OpenClosed 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
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 GoNo-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 OpenClosed 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 ie yogurt drinks ie 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 linesproducts 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 Its 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 PoZibiopost 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 GoNo-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 OpenClosed 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
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 GoNo-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 OpenClosed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None