RecruitingEarly Phase 1NCT07794956

LpD3.5 Intervention Study in Older Adults- LISA-I Trial

A Postbiotics Intervention to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment (Phase 1)


Sponsor

University of South Florida

Enrollment

15 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized placebo-controlled clinical study, called the LpD3.5 Intervention Study in Older Adults (LISA), aims to evaluate whether a heat-inactivated postbiotic of human origin (LpD3.5) can serve as a non-pharmacological intervention to reduce gut permeability and inflammation in older adults with mild cognitive impairment (MCI). The study will assess the effects of LpD3.5 supplementation on markers associated with gut health, inflammation, microbiome composition, and cognitive function. Participants aged 60 years or older with clinically diagnosed MCI will receive either LpD3.5 capsules or placebo capsules for 60 days, followed by a 30-day follow-up period. Biological samples and clinical assessments will be collected to evaluate changes in gut permeability, inflammatory markers, microbiome characteristics, and cognitive outcomes. The findings from this study may provide insight into the potential role of postbiotics as a dietary intervention to improve gut health and related outcomes in older adults with MCI.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying LpD3.5 and Placebo for people with brain aging, cognition, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTLpD3.5

LpD3.5 is a human-origin Lactobacillus paracasei strain, a commonly used probiotic species recognized as safe (GRAS). The heat-inactivated postbiotic is produced and packaged in certified facilities for human consumption.

DIETARY_SUPPLEMENTPlacebo

Inactive ingredients like maltodextrin; placebo capsules contain only inactive ingredients.


Locations(1)

Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute

Tampa, Florida, United States

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NCT07794956


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