Augmenting Cognitive Function in the Elderly with Mild Cognitive Impairment Using Probiotic Lacticaseibacillus rhamnosus CBT-LR5: A 12-Week Randomized, Double-Blind, Parallel-Group Non-Comparative Study.

Publisher: MDPI Publishing Country of Publication: Switzerland NLM ID: 101521595 Publication Model: Electronic Cited Medium: Internet ISSN: 2072-6643 (Electronic) Linking ISSN: 20726643 NLM ISO Abbreviation: Nutrients Subsets: MEDLINE

Original Publication: Basel, Switzerland : MDPI Publishing

Probiotics*/administration & dosage ; Probiotics*/therapeutic use ; Cognitive Dysfunction*/therapy ; Cognitive Dysfunction*/psychology ; Lacticaseibacillus rhamnosus* ; Cognition*/drug effects; Humans ; Double-Blind Method ; Aged ; Female ; Male ; Middle Aged ; Milk ; Treatment Outcome

Background: Probiotics have been shown to enhance cognitive function in individuals with mild cognitive impairment (MCI), but their efficacy varies, depending on the strain and dosage.
Objectives: Clinical investigations are crucial to confirm their safety, efficacy, and mechanism of action. This study was designed to assess the effective dosage, safety, and efficacy of MH-Pro, a test product containing Lacticaseibacillus rhamnosus CBT-LR5 (LR5) and skim milk (non-fat dry milk), in improving cognitive function and related physiological changes in older adults suspected of MCI over 12 weeks.
Methods: In total, 20 participants (mean age: 68.9 years) were randomly assigned in a 1:1 ratio to either a low-dose group (1 × 10 ¹⁰ CFU LR5 with 1622 mg) or a high-dose group (1 × 10 ¹⁰ CFU LR5 with 4055 mg skim milk) in a double-blind, parallel-group clinical trial.
Results: After 12 weeks, the low-dose group showed significant improvements in the MOCA-K subdomains, specifically in naming ( p = 0.01) and delayed recall ( p = 0.003). Additionally, levels of amyloid-β1 40/42 in the blood significantly decreased ( p = 0.03) following supplementation in the low-dose group. The high-dose group exhibited significant improvement in orientation ( p = 0.05). Moreover, overall cognitive enhancement was observed in the low-dose group ( p = 0.003), while the high-dose group showed a trend toward improvement ( p = 0.06). Fecal analysis revealed significant changes in bacterial composition, with an increase in Lacticaseibacillus after 12 weeks of MH-Pro consumption. Together, these findings provide foundational evidence suggesting that MH-Pro supplementation may serve as a potential intervention for enhancing cognitive function through gut-brain axis pathways in the elderly population. However, given the small sample size and the predominance of female participants, the impact of the outcome may be limited. Further large-scale studies are necessary to validate these preliminary results.
Conclusions: This study provides foundational evidence to recognize the use of LR5 and skim milk to prepare a probiotic supplement that enhances cognitive function in the aging population.

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Commercialization Promotion Agency for R&D Outcomes (COMPA): Project Number: 1711177801 Ministry of Science and ICT

Keywords: Lacticaseibacillus rhamnosus CBT-LR5; clinical trial; cognitive function; mild cognitive impairment (MCI); probiotics; skim milk

Date Created: 20250226 Date Completed: 20250226 Latest Revision: 20250509

20250510

PMC11858765

10.3390/nu17040691

40005019