Clinically relevant benefits in terms of cognitive function Not Applicable
Conditions
Interventions
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
Sponsors
Welsh Government
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects over 50 years of age 2. Subjects with Mini-Mental State Exam (MMSE) of 25-30 inclusive (global cognitive function) 3. Subjects who are able to undergo EEG and to commit to visits to WARU/P5. 4. Subjects who are able to provide venous blood samples. 5. Subjects able to provide written informed consent PRIOR to performing any study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with 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 with Geriatric Depression Scale > 6 5. Subjects with a Mini Mental State Exam score below 25 6. Subjects who are pregnant or lactating 7. Subjects with medical condition or disease that is life threatening 8. Subjects who smoke cigarettes or use other products containing nicotine. 9. Subjects diagnosed with diabetes. 10. Subjects taking warfarin. 11. Subjects who identify as being vegetarian or vegan 12. Subjects who have a diagnosed or suspected mental health condition, or who have any concerns surrounding their mental health 13. Subjects who have immediate family members with diagnosed mental health condition or suspected mental health concerns
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline and 6 weeks: 1. Cognitive Control (Selective attention, processing speed, mental flexibility) measured using the Stroop task in E-Prime 2. Response inhibition (core construct in cognitive control and self-regulation) measured using the Go/No-go task in E-Prime (commission errors score) 3. Selective attention and response inhibition (core constructs in cognitive control and self-regulation) measured using the Flanker task in E-Prime (response time and accuracy) 4. 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 5. 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 6. 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 7. Electroencephalogram (EEG) during the stroop, Flanker and go/no-go tasks assessing alpha and delta activity 8. EuroQol 5 Dimension 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and 6 weeks: 1. C -reactive protein in plasma as a marker of inflammation 2. Kidney function tests including sodium/potassium/creatinine/urea 3. Total Cholesterol using blood test 4. Total Triglyceride using blood test 5. Liver function tests (LFTs). Aspartate aminotransferase (AST), Alanine transaminase (ALT), Alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT), Prothrombin time (PT), Albumin, using blood test 6. Changes in short chain fatty acids concentrations in plasma measured using Gas Chromatography-Flame Ionization Detection | — |
Countries
United Kingdom, Wales
Outcome results
None listed