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Probiotic Intervention on Gut Microbiota and Cognitive Functioning in Older Adults With a Mild Cognitive Impairment

NCT05859230 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-05-15

No results posted yet for this study

Summary

Recent studies suggest that gut microbiota is linked to cognitive performance and modulating gut microbiota is a safe and promising approach to enhance cognition. The limited studies in the area of probiotics for cognitive impairment in early stages warrant further research. In this feasibility study, we will examine the effects of probiotic consumption in older adults with mild cognitive impairment (MCI), on gut microbiota and cognition via microbiota composition, inflammatory, immune, and bacterial metabolite mechanisms, using neuropsychological tests. The single probiotic contains the Lacticaseibacillus paracasei strain Shirota (LcS), with proven efficacy in various health conditions as well as in stress, sleep, and mood disorders; but to our knowledge, it has not been rigorously examined in early stages of cognitive impairment. After 12 weeks of the randomized, double-blinded probiotic/placebo intervention, we hypothesize that the changes in the composition of gut microbiota, short-chain fatty acids, and the inflammatory/immunological markers, could improve functional connectivity and cognition.

Conditions

Interventions

DIETARY_SUPPLEMENT

Experimental: The probiotic drink study group

The 100 ml volume of milk drink containing 10 billion Lacticaseibacillus paracasei strain Shirota is consumed once a day for 12-week intervention period, followed by a 6-week follow-up period. The intervention is double-blinded by study team members and subjects. The milk drink bottles are coded by the manufacturing company.

DIETARY_SUPPLEMENT

Placebo Comparator: The placebo drink study group

The 100 ml volume of milk drink without containing Lacticaseibacillus paracasei strain Shirota is consumed once a day for 12-week intervention period, followed by a 6-week follow-up period. The intervention is double-blinded to study team members and subjects. The milk drink bottles are coded by the manufacturing company.

Sponsors & Collaborators

Principal Investigators

  • Rathi Mahendran, M.B.,B.S · National University of Singapore

  • Su Hui Ho, M.B.,B.S · National University of Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-05
Primary Completion
2023-06-01
Completion
2023-12-01

Countries

  • Singapore

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05859230 on ClinicalTrials.gov