Cognitive Decline Clinical Trial
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. 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03228446 -
The Effects of Attentional Filter Training on Working Memory
|
N/A | |
Completed |
NCT04033419 -
Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer
|
Phase 2 | |
Terminated |
NCT05199142 -
A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline
|
Phase 1 | |
Active, not recruiting |
NCT05290233 -
Time Restricted Eating Plus Exercise for Weight Management
|
N/A | |
Terminated |
NCT03337282 -
Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
|
||
Unknown status |
NCT00696514 -
Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People
|
Phase 1 | |
Completed |
NCT00110604 -
The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
|
N/A | |
Recruiting |
NCT06245005 -
Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
|
||
Recruiting |
NCT05014399 -
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
|
||
Active, not recruiting |
NCT05586750 -
Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy
|
Phase 4 | |
Completed |
NCT04386902 -
Evaluation of Cognitive State Using Neurosteer EEG System
|
||
Recruiting |
NCT06070818 -
Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline
|
N/A | |
Completed |
NCT01669915 -
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
|
N/A | |
Completed |
NCT02814526 -
Exercise in Adults With Mild Memory Problems
|
N/A | |
Not yet recruiting |
NCT06252376 -
Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in PD
|
N/A | |
Not yet recruiting |
NCT05928078 -
A Home-based e-Health Intervention in the Elderly: MOVI-ageing
|
N/A | |
Recruiting |
NCT06318377 -
Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals
|
N/A | |
Recruiting |
NCT03839784 -
Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
|
||
Completed |
NCT04537728 -
My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices
|
N/A | |
Active, not recruiting |
NCT03370796 -
Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context
|
N/A |