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| ID | Type | Description | Link |
|---|---|---|---|
| 2021/43/O/HS6/02074 | Other Grant/Funding Number | National Science Centre Poland |
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| Name | Class |
|---|---|
| Sanprobi Sp. z o. o. | UNKNOWN |
| National Science Centre, Poland | OTHER_GOV |
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The goal of this study is to explore the potential impact of an anti-inflammatory probiotic mixture of psychobiotics including Bifidobacterium longum Rosell®-175 and Lactobacillus helveticus Rosell®-52 on cognitive functions in older adults following either pro-inflammatory or anti-inflammatory diets. According to recent findings, even short-term exposure to foods with pro- or anti-inflammatory properties may lead to corresponding negative or beneficial effects on cognitive functioning .
The main questions this study aims to answer are:
The investigators will compare probiotic to a placebo (a look-alike substance that contains no active ingredients) to determine whether probiotic is effective in enhancing cognitive function.
Participants:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-inflammatory diet + probiotic first | Experimental | This is a group of participants whose everyday dietary pattern was assessed as anti-inflammatory based on the Shivappa et al. (2014) equation, and who will receive probiotics during the first 3 months of the study. |
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| Anti-inflammatory diet + placebo first | Experimental | This is a group of participants whose everyday dietary pattern was assessed as anti-inflammatory based on the Shivappa et al. (2014) equation, and who will receive placebo during the first 3 months of the study. |
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| Pro-inflammatory diet + probiotic first | Experimental | This is a group of participants whose everyday dietary pattern was assessed as pro-inflammatory based on the Shivappa et al. (2014) equation, and who will receive probiotics during the first 3 months of the study. |
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| Pro-inflammatory diet + placebo first | Experimental | This is a group of participants whose everyday dietary pattern was assessed as pro-inflammatory based on the Shivappa et al. (2014) equation, and who will receive placebo during the first 3 months of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo | Dietary Supplement | Each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for 3 months.
After completion of the first phase, each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for another 3 months.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Differentiation score in California Verbal Learning Test (CVLT) to assess long-term memory | California Verbal Learning Test (CVLT) measure the verbal learning and memory. It measures how well individuals learn and recall verbal material, assessing both short-term and long-term memory. The Differentiation score measures the ability to distinguish between correct and incorrect responses. Scores range from 0 to 16, with higher scores indicating better outcome. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in d' score in old/new recognition test (ONR) to assess long-term memory | The old/new word recognition task is designed to assess episodic memory. It is consisted of two phases: a learning phase and a recognition phase. During the learning phase, participants viewed 30 pictures on the computer. In the recognition phase, participants were presented with 30 "old" and 30 "new" pictures in random order and were asked to determine whether each picture had been shown during the learning phase. To analyze episodic memory task we followed Macmillan and Creelman (2005) signal detection theory, where d' is the ability to discriminate between signal and noise (between old and new stimuli), H stands for the proportion of correct changes detected (hit rate), and F stands for the proportion of changes incorrectly reported (false alarm rate). d' = zH - zF | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in N400 event-related potential (ERP) component amplitude to assess long-term memory | The N400 ERP component will be measured during an old/new word recognition task designed to assess episodic memory. The task involves presenting participants with previously studied ("old") and novel ("new") words while EEG is recorded. The N400 component-typically observed as a negative deflection peaking around 400 ms post-stimulus-is sensitive to familiarity and memory retrieval. A reduced N400 amplitude for old versus new words is interpreted as successful recognition. Changes in N400 amplitude over time will indicate modulation of episodic memory performance across the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Beck Depression Inventory (BDI) total score to assess symptoms of depression | Scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary inflammatory index | Dietary Inflammatory Index assessment based on the Shivappa et al. (2014) equation. It classifies participants' dietary patterns as pro-inflammatory, neutral, or anti-inflammatory. Scores ranged from -8.87 (maximally anti-inflammatory diet) to +7.98 (maximally pro-inflammatory diet). | Baseline (prior to intervention) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SWPS University | Warsaw | Masovian Voivodeship | 03-815 | Poland |
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Randomized, double-blind, and placebo-controlled study
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| Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) | Dietary Supplement | Each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for 3 months.
After completion of the first phase, each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for another 3 months.
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| Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Changes in the Fatigue Assessment Scale (FAS) total score to assess symptoms of chronic fatigue |
Scores range from 10 to 50, with higher scores indicating greater fatigue. |
| Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in the number of correctly marked target characters in the d2 Test of Attention (d2-R) - to assess attention. | Scores range from 0 to 308, with higher scores indicating better outcome. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Concentration score in d2 Test of Attention (d2-R) - to assess attention | Scores range from 0 to 308, with higher scores indicating better outcome. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Wechsler Adult Intelligence Scale (WAIS) Digit Symbol Substitution subtest total score to assess cognitive processing speed, visual-motor coordination, and sustained attention | Scores range from 0 to 39, with higher scores indicating better outcome. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Wechsler Adult Intelligence Scale (WAIS) Digit Span Forward subset total score to assess short-term auditory memory | Scores range from 0 to 14, with higher scores indicating better outcome. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Wechsler Adult Intelligence Scale (WAIS) Digit Span Backward subset total score to assess short-term auditory memory | Scores range from 0 to 14, with higher scores indicating better outcome. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Wechsler Adult Intelligence Scale (WAIS) Block Design subtest total score to assess visual domains such as visuoperceptive, visuospatial and visuoconstructive functions | Scores range from 0 to 54, with higher scores indicating better outcome. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Color Trails Test (CTT) total mistakes - CTT1 to assess several attention and executive functions especially perceptual tracking, sustained and divided attention | There is no predefined maximum number of errors in the test. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Color Trails Test (CTT) total mistakes - CTT2 to assess several attention and executive functions especially perceptual tracking, sustained and divided attention | There is no predefined maximum number of errors in the test. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Color Trails Test (CTT) completion time - CTT1 to assess several attention and executive functions especially perceptual tracking, sustained and divided attention | A maximum time limit of 240 seconds (4 minutes) is applied. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Color Trails Test (CTT) completion time - CTT2 to assess several attention and executive functions especially perceptual tracking, sustained and divided attention | A maximum time limit of 240 seconds (4 minutes) is applied. | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in Color Trails Test (CTT) Interference score - to assess several attention and executive functions especially perceptual tracking, sustained and divided attention | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Change in P300 event-related potential (ERP) component amplitude to assess attention | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Changes in diversity in microbial community in a single sample (alpha-diversity) | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Changes in diversity in microbial community between samples (beta-diversity) | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Changes in differential abundance of microbial community | Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover. |
| Score in Mini-mental state examination (MMSE) |
A screening tool for cognitive impairment with older adults. It is scored on a scale from 0 to 30. 27-30 points: Normal result, no cognitive impairment 24-26 points: Cognitive impairment without dementia 19-23 points: Mild dementia 11-18 points: Moderate dementia 0-10 points: Severe dementia |
| Baseline (prior to intervention) |
| Score in the Raven's Progressive Matrices test | The Raven's Progressive Matrices test is used to measure the level of general intelligence, understood as fluid intelligence. It is scored on a scale from 0 to 60, with higher scores indicating better outcome. | Baseline (prior to intervention) |
| Score in Adherence to the Mediterranean diet | The scale ranges from 0 to 7, with higher scores reflecting greater adherence to the Mediterranean diet. | Baseline (prior to intervention) |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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