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

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07794956
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Brain Aging
  • Cognition
  • Gut Inflammation
  • Inflammaging
  • Leaky Gut Syndrome
  • Microbiome Dysbiosis
  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • LpD3.5 — DIETARY_SUPPLEMENT
    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.
  • Placebo — DIETARY_SUPPLEMENT
    Inactive ingredients like maltodextrin; placebo capsules contain only inactive ingredients.

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Mar 3, 2026
Status verified
Aug 2026
Primary completion
Nov 15, 2026
Completion
Nov 15, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: LpD3.5 group
    This group will receive LpD3.5 (2 capsules per day) for a duration of 60 days with follow-up at 90-day.
  • Placebo Comparator: Placebo group
    They will receive a bottle of placebo capsules (2 capsules per day) for a duration of 60 days with follow-up at 90 days

Primary Outcome Measure

Change in Plasma Lipopolysaccharide-Binding Protein (LBP) Level [ Time Frame: Baseline to Day 60 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes InstituteTampaFlorida33612
Hariom Yadav, PhD
[email protected]
8139748222
Shalini Jain, PhD
[email protected]

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By research site
Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute· Tampa, FL

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