MedTrace Logo

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

NCT07794956 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-31

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

LpD3.5

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_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2026-11-15
Completion
2026-11-15

Countries

  • United States

Study Locations

More Related Trials

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 NCT07794956 on ClinicalTrials.gov