Probiotic supplementation on cognitive and other aging-related physiological functions in middle-aged and older adults with mild cognitive impairment (PCAMCI): protocol for a randomized, triple-blinded, placebo-controlled trial
Bibliographic record
Abstract
BACKGROUND: Emerging evidence suggests gut microbiota modulation may influence neurocognitive function through the gut-brain axis. Although preliminary studies indicate probiotics' potential benefits for mild cognitive impairment (MCI), well-designed randomized controlled trials remain limited. This protocol paper describes a rigorously designed, registered clinical trial investigating the effects of targeted probiotic supplementation on cognitive and physiological outcomes in MCI participants. METHODS: A total of 110 middle-aged and older participants aged 55-80 years with MCI were scheduled to be included in the study, and randomized in a 1:1 ratio to either a probiotic group receiving supplementation consisting of Lactiplantibacillus plantarum ST-III, Lacticaseibacillus rhamnosus KF7, and Lacticaseibacillus paracasei BD5115, or a placebo group with maltodextrin for 12 months. All the participants, researchers, and analysts will remain blinded to the information regarding group allocation in the study. The primary outcome will be the effect of probiotic supplementation on cognitive function, measured by Montreal Cognitive Assessment (the Chinese Beijing Version). The secondary outcomes will include the impact of probiotic supplementation on digestive health, sleep health, facial aging, fundus conditions, olfactory and auditory function, body composition, bone density, and muscle function. Brain magnetic resonance imaging and wearable device including continuous glucose monitor and smart band will also be employed. DISCUSSION: This study will provide some new insights on how probiotic supplementation could impact cognitive function and other aging-related physiological functions in MCI adults and explore the potential underlying mechanisms. The findings may inform the development of strategies to delay cognitive decline by modulating the gut-brain axis in this high-risk population. TRIAL REGISTRATION: ChiCTR2400084594.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".