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This randomized, double-blind, placebo-controlled trial will evaluate whether 12 weeks of supplementation with the probiotic Lactobacillus rhamnosus GG combined with colon-delivered riboflavin will improve cognitive performance and brain physiology in older adults with memory complaints. The study will assess changes in cognitive outcomes together with neurophysiological markers to explore potential gut-brain axis mechanisms. Through its rigorous design, the trial will aim to determine whether targeted modulation of the intestinal environment can support brain function and cognitive health in aging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | 2 capsules of probiotic and riboflavin cellulose per day |
|
| Experimental 2 | Placebo Comparator | 2 capsules of microcrystaline cellulose per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental 1 | Dietary Supplement | Probiotic and riboflabin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assesment scores | The Montreal Cognitive Assessment (MoCA) score is a brief, 30-point screening measure of global cognitive function. It assesses multiple domains, including memory, attention, executive function, language, visuospatial abilities, and orientation. Higher scores indicate better cognitive performance, with a score of 26 or above generally considered within the normal range, while lower scores suggest varying degrees of cognitive impairment. | Change from baseline The Montreal Cognitive Assessment (MoCA) score at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination Score | The Mini-Mental State Examination score quantifies global cognitive function by assessing orientation, memory, attention, language, and visuospatial abilities, offering a validated measure for detecting cognitive decline in older adults. | Change from baseline Mini-Mental State Examination Score at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergej Ostojic, MD, PhD | Contact | +381112643242 | sergej.ostojic@chess.edu.rs |
| Name | Affiliation | Role |
|---|---|---|
| Nikola Todorovic, PhD | Center for Mitochondrial Medicine | Principal Investigator |
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Data obtained through this study may be provided to qualified researchers with academic interest in nutritional science. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Only qualified researchers with academic interest in nutritional science.
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D008224 | Lymphoma, Follicular |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| Experimental 2 |
| Dietary Supplement |
Microcrystaline cellulose |
|
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-report tool used to assess sleep quality and disturbances. It consists of 19 items covering seven components: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, daytime dysfunction, and use of sleep medications. Each component is scored from 0 to 3, with higher scores indicating worse sleep quality. The total score ranges from 0 to 21, where a score of 5 or higher suggests poor sleep quality. The PSQI is widely used in clinical and research settings to evaluate sleep health. | Change from baseline PSQI at 12 weeks |
| Brain oxygen saturation | Concentration of hemoglobin index in prefrontal brain | Change from baseline hemoglobin index at 12 weeks |
| Grip strength | Muscular strength generated by one's forearm muscles | Change from baseline grip strength at 12 weeks |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |