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.
Be 60 years or older
Willingness to participate in the study and provide consent
Ability to have regular contact with the participant(s)
Be knowledgeable about the participant's health, memory, and daily activities
None
Parallel
LpD3.5
Dietary supplementLpD3.5 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 supplementInactive ingredients like maltodextrin; placebo capsules contain only inactive ingredients.
Change in Plasma Lipopolysaccharide-Binding Protein (LBP) Level
Change in plasma lipopolysaccharide-binding protein (LBP) concentration from baseline to Day 60. LBP will be measured using an enzyme-linked immunosorbent assay (ELISA) as a marker of elevated gut permeability.
Change in Stool Mucin Level
Change in stool mucin level from baseline to Day 60. Stool mucin will be measured using an enzyme-linked immunosorbent assay (ELISA).
Change in Plasma C-Reactive Protein (CRP) Level
Change in plasma C-reactive protein (CRP) concentration from baseline to Day 60 as a marker of systemic inflammation.
Change in Plasma Interleukin-6 (IL-6) Level
Change in plasma interleukin-6 (IL-6) concentration from baseline to Day 60 as a marker of systemic inflammation.
Change in Plasma Tumor Necrosis Factor-Alpha (TNF-α) Level
Change in plasma tumor necrosis factor-alpha (TNF-α) concentration from baseline to Day 60 as a marker of systemic inflammation.
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