What this means
This study will give some people capsules and others placebo capsules, then compare gut health, inflammation, and thinking skills. It has not reported results yet, so it does not show whether the capsules help.
Plain-English summary written by an AI model from the registry listing.
- Status
- Recruiting
- Who can join
- Ages 60 and over
- Where
- 1 site, including Florida
The science
- Registered title
- LpD3.5 Intervention Study in Older Adults- LISA-I Trial
- Trial ID
- NCT07794956 ↗
- Phase
- EARLY PHASE 1
- Study type
- interventional
- Conditions
- Mild Cognitive Impairment (MCI), Cognition, Brain Aging, Microbiome Dysbiosis, Leaky Gut Syndrome, Gut Inflammation, Inflammaging
- What is tested
- LpD3.5, Placebo
- Sponsor
- University of South Florida
- Ages
- 60 Years to no maximum
- Dates
- First posted Aug 31, 2026 · updated Aug 31, 2026
Registry 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.
Sites (1)
- Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute, Tampa, Florida, United States