Healthy middle-aged and older subjects to assess the potential for improved physiological, gut and cognitive health Other
Conditions
Interventions
A randomised, double-blinded, placebo-controlled, multi-centre, parallel human intervention trial of heat-treated Lactobacillus paracasei D3.5 (post-biotics) and/or Cerbella supplementation in healthy
Sponsors
Aberystwyth University
Eligibility
Sex/Gender
All
Age
55 Years to 111 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/10/2025: 1. Subjects over 55 years of age 2. Subjects able to provide written informed consent PRIOR to performing any study procedures 3. Subjects who can commit to visits to one of the centres 4. Subjects who are willing to complete a series of questionnaires including the: Pittsburgh Sleep Quality Index (PSQI), 36-Item Short Form Health Survey (SF-36), Warwick-Edinburgh Mental Wellbeing Scale (WEMWS), and the Gastrointestinal Symptom Rating Scale (GSRS) 5. Subjects who are willing to provide capillary blood, stool, and urine samples, and commit to EEG appointments Previous inclusion criteria: 1. Subjects over 60 years of age 2. Subjects able to provide written informed consent PRIOR to performing any study procedures 3. Subjects who can commit to visits to one of the centres 4. Subjects who are willing to complete a series of questionnaires including the: Pittsburgh Sleep Quality Index (PSQI), Mini Mental State Exam (MMSE), 36-Item Short Form Health Survey (SF-36), Warwick-Edinburgh Mental Wellbeing Scale (WEMWS), and the Gastrointestinal Symptom Rating Scale (GSRS) 5. Subjects who are willing to provide capillary blood, stool, and urine samples, and commit to EEG appointments
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 24/09/2024: 1. Subjects with a diagnosis of Alzheimer’s disease, Parkinson's or other dementia 2. 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 3. Subjects who are already regularly taking probiotics, post-biotics, nutraceutical and/or vitamin supplements related to PoZibio ™ within 30 days of screening 4. Subjects who are pregnant or lactating 7. Subjects with a medical condition or disease that is life-threatening 8. Subjects who smoke cigarettes or use other products containing nicotine 9. Subjects who have been taking antibiotics, and/or having diarrhea and vomiting in the past 30 days 10. Any subjects to whom PI feels not to be eligible based on critical conditions 11. Subjects who have a diagnosed or suspected mental health condition, or who have any concerns surrounding their mental health 12. Subjects who are vegetarian/vegan Added 27/10/2025: Note: During screening, participants were asked about any dietary restrictions. Those who were vegetarian/vegan were informed that they could still take part in the trial, but that they would only be randomly allocated to one of two out of the four arms (active PoZibio ™/Cerbella™ placebo or double placebo). This change was made to make the trial more inclusive. Previous participant exclusion criteria: 1. Subjects with a diagnosis of Alzheimer’s disease or other dementia 2. 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 3. Subjects who are already regularly taking probiotics, post-biotics, nutraceutical and/or vitamin supplements related to PoZibio ™ within 30 days of screening 4. Subjects who are pregnant or lactating 7. Subjects with a medical condition or disease that is life-threatening 8. Subjects who smoke cigarettes or use other products containing nicotine 9. Subjects who have been taking antibiotics, and/or having diarrhea and vomiting in the past 30 days 10. Any subjects to whom PI feels not to be eligible based on critical conditions 11. Subjects who have a diagnosed or suspected mental health condition, or who have any concerns surrounding their mental health 12. Subjects who are vegetarian/vegan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 27/10/2025: 1. Cognitive Control (Selective attention, response inhibition and processing speed) measured using the Stroop Task in EPrime (faster response time and improved accuracy; reduced Stroop interference) from baseline score at 60 days after intervention 2. Working memory and mental flexibility, measured using the NBack Task in EPrime (faster response time and improved accuracy for correctly identifying targets) from baseline score at 60 days after intervention 3. Assessing event-related potentials (ERPs) using an electroencephalogram (EEG) in the N2, P3 and LPC components across the frontal and parietal regions, during a Stroop and NBack task. After 60 days of intervention, reduced N2 amplitude and/or shorter N2 latency; larger P3 amplitude and shorter latency; increased LPC amplitude and shorter latency. Indicative of improved conflict detection, stimulus categorisation, and cognitive control. 4. Assessing Delta, Theta and Alpha activity using an EEG during the Stroop and NBack tasks. After 60 days of intervention, reduced theta activity (frontal midline) during incongruent trials (improved conflict monitoring); increased alpha power (parieto-occipital) during tasks (improved attentional control); reduced delta activity (frontal) indicating reduced cognitive load during tasks. Previous primary outcome measures: 1. Cognitive Control (Selective attention, processing speed, mental flexibility) measured using the Stroop task in E-Prime (faster response time and improved accuracy) from baseline score at 60 days after intervention 2. Response inhibition (core construct in cognitive control and self-regulation) measured using the Go/No-go task in E-Prime (fewer commission errors) score from baseline score at 60 days after intervention 3. Assessing event-related potentials (ERPs) in the P3 component and the N2 component across the frontal and parietal regions measured using an electroencephalogram (EEG) during the Stroop tas | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed at baseline and 60 days after intervention: 1. Cognition measured using the Mini-Mental State Exam (MMSE) (removed 27/10/2025) 2. Health measured using the 36-item Short Form Health Survey (SF-36) 3. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) 4. Gastrointestinal health measured using the Gastrointestinal Symptom Rating Scale (GSRS) 5. Mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWS) 6. Inflammation measured using fecal mucin levels with an ELISA kit 7. Inflammation measured using fecal calprotectin levels with an ELISA kit 8. Leaky gut markers (LBP, sCD14, Zonulin) measured in plasma with an ELISA kit 9. Inflammatory cytokines (TNF-alpha, IL-6) measured in plasma 10. Total short-chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection 11. Metabolomic Fingerprint in Plasma: Polar and non-polar chemistry in plasma measured using Flow Infusion Electrospray Ionisation Mass Spectrometry (FIE-MS) 12. Metabolomic Fingerprint in Urine: Polar and non-polar chemistry in urine measured using Flow Infusion Electrospray Ionisation Mass Spectrometry (FIE-MS) 13. Microbiome in Stools: Microbiome diversity and phylogenetic abundances in stools measured using whole genome sequencing | — |
Countries
England, Scotland, United Kingdom, United States of America, Wales
Contacts
Public ContactAmanda Jane Lloyd
Outcome results
None listed