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| Name | Class |
|---|---|
| Bened Biomedical Co., Ltd. | INDUSTRY |
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This open label study aims to evaluate whether the consumption of probiotics can improve symptoms and overall quality of life in individuals experiencing cognitive decline symptoms, as well as to evaluate the effects of probiotics on blood-related biomarkers.
Lacticaseibacillus paracasei PS23 (PS23) is a specific strain of probiotic bacteria known for its potential health benefits, particularly in the context of aging and muscle health. Research suggests that it may improve cognitive function, reduce age-related muscle loss, and modulate the gut microbiota. Probiotic supplements like PS23 are being explored as potential therapeutic agents for age-related cognitive deficits. A prior study showed that PS23 supplementation delayed age-related cognitive decline in mice. Additionally, PS23 has shown antidepressant-like effects and has been found to enhance physical performance and promote muscle recovery following injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Lacticaseibacillus paracasei PS23 one capsule daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacticaseibacillus paracasei | Dietary Supplement | one capsule daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention | Cambridge Neuropsychological Test Automated Battery (CANTAB®) includes computerized tests that are correlated to neural networks and have demonstrated high sensitivity in detecting changes in neuropsychological performance. | baseline to 12 weeks assessed |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Chinese version of Trail Making Test (TMT) in 40 subjects after probiotic intervention | The Trail Making Task (TMT) is a neuropsychological test consisting of two parts that assesses executive function, visual attention, speed of processing, and cognitive flexibility. In Part A, the participant connects 25 numbered circles in sequential numerical order (1 to 25) as quickly and accurately as possible. TMT-B with sequential numbers in the Chinese characters substituting for the English alphabetical sequence, replaced numbers and letters of the TMT-B by circles and squares with numbers, modified the TMT-B with the Chinese zodiacs substituting for the English alphabet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi-Chang Huang, PhD | National Taiwan Sport University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graduate Institute of Sports Science, National Taiwan Sport University | Taoyuan | 33301 | Taiwan |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| baseline to 12 weeks assessed |
| Changes in Chinese version of Stroop color words test(SCWT) in 40 subjects after probiotic intervention | The Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function | baseline to 12 weeks assessed |
| Changes in Geriatric Depression Scale in 40 subjects after probiotic intervention | The Geriatric Depression Scale (GDS) is a screening tool for depression in older adults (55+), consisting of a short, yes/no questionnaire about feelings over the past week. Scores range between 0 and 30 points. Higher scores indicate more severe depressive symptoms. | baseline to 12 weeks assessed |
| Changes in Anxiety Disorder Assessment (GAD-7) in 40 subjects after probiotic intervention | The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day" | baseline to 12 weeks assessed |
| Changes in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) in 40 subjects after probiotic intervention | The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 is a valid, reliable self-report instrument for assessing quality of life. The minimum raw score on the Q-LES-Q-16 is 14, and the maximum score is 70, higher scores mean a better outcome. | baseline to 12 weeks assessed |
| Changes in Patient Global Impression scales of Improvement rated by patient （PGI-C) in 40 subjects after probiotic intervention | The PGIC consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome. | baseline to 12 weeks assessed |
| Changes in pTau-217 in 40 subjects after probiotic intervention | Recent, research studies have shown that plasma levels of p-Tau 217 are elevated in AD patients1,2. Additionally, it has been demonstrated that plasma p-Tau 217 levels are increased in the early stages of the AD continuum and are correlated with amyloid-PET positivity. | baseline to 12 weeks assessed |
| Changes in Plasma Aβ40 and Aβ42 in 40 subjects after probiotic intervention | Plasma Aβ42/Aβ40 is sensitive to early cerebral amyloid accumulation and predicts risk of cognitive decline across the Alzheimer's disease spectrum | baseline to 12 weeks assessed |
| Changes in Brain-derived neurotrophic factor (BDNF) in 40 subjects after probiotic intervention | Brain-derived neurotrophic factor (BDNF) plays an important role in neuronal survival and growth, serves as a neurotransmitter modulator, and participates in neuronal plasticity, which is essential for learning and memory. | baseline to 12 weeks assessed |
| Changes in Glial Fibrillary Acidic Protein (GFAP) in 40 subjects after probiotic intervention | Glial fibrillary acidic protein (GFAP), an astrocytic cytoskeletal protein, can be measured in blood samples, and has been associated with Alzheimer's disease (AD). | baseline to 12 weeks assessed |
| Changes in Neurofilament Light (NfL) in 40 subjects after probiotic intervention | Neurofilament light chain (NfL) is a structural protein that normally helps support the shape and function of brain cells. In Alzheimer's disease (AD), brain cells are damaged, which causes the brain to shrink (atrophy), and symptoms such as declining cognition to occur. | baseline to 12 weeks assessed |
| Changes in Mandarin Subjective Cognitive Decline Scale (SCDS) in 40 subjects after probiotic intervention | Self-reported questionnaire consisting of 14 items assessing perceived decline in memory, attention, language, planning, orientation, and other cognitive domains. Responses are typically rated on a Likert scale (e.g., 0 = "Never" to 4 = "Very frequently"), with total scores ranging from 0 to 56-higher scores indicate greater subjective cognitive complaints. | screening, baseline to 12 weeks assessed |