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

28 de agosto de 2026 atualizado por: University of South Florida

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

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.

Visão geral do estudo

Descrição detalhada

This randomized, placebo-controlled clinical trial, known as the LpD3.5 Intervention Study in Older Adults (LISA), is designed 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 whether LpD3.5 supplementation can improve gut barrier function, microbiome characteristics, and health-related outcomes associated with cognitive decline.

The primary objective of this study is to determine whether daily oral administration of dietary supplement-grade LpD3.5 (two capsules per day) reduces elevated gut permeability in older adults with MCI, as measured by plasma lipopolysaccharide-binding protein (LBP), a marker associated with intestinal barrier dysfunction.

The secondary objective is to determine whether LpD3.5 supplementation improves gut-related factors, including fecal mucin levels and gut microbiome composition, and whether these changes are associated with reduced inflammation and improved cognitive function. Inflammatory markers in stool and blood, including calprotectin, C-reactive protein (CRP), IL-6, TNF-α, and IL-1β, as well as cognitive outcomes assessed using standardized cognitive measures, will be evaluated.

Exploratory objectives include evaluating changes in blood pTau217 levels and examining potential relationships between LpD3.5 supplementation, gut permeability, microbiome alterations, inflammation, and cognitive function.

The rationale for this study is based on growing evidence that age-related changes in the gut microbiome may contribute to increased intestinal permeability, chronic inflammation, and cognitive decline. Previous preclinical studies have demonstrated that heat-inactivated LpD3.5 improves gut barrier function, reduces inflammation, and enhances cognitive and metabolic outcomes in aging models. This clinical study will investigate whether these beneficial effects translate to older adults with MCI.

Participants aged 60 years or older with clinically diagnosed MCI will be randomized to receive either LpD3.5 capsules or placebo capsules for 60 days, followed by a 30-day follow-up period. The study is designed to provide preliminary evidence regarding the safety, biological effects, and potential mechanisms of LpD3.5 as a dietary postbiotic intervention for improving gut health and related outcomes in older adults with MCI.

Tipo de estudo

Intervencional

Inscrição (Estimado)

15

Estágio

  • Fase inicial 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Hariom Yadav, PhD
  • Número de telefone: 8139748222
  • E-mail: hyadav@usf.edu

Estude backup de contato

  • Nome: Shalini Jain, PhD
  • Número de telefone: +1 8139746281
  • E-mail: jains10@usf.edu

Locais de estudo

    • Florida
      • Tampa, Florida, Estados Unidos, 33612
        • Recrutamento
        • Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute
        • Contato:
          • Hariom Yadav, PhD
          • Número de telefone: 8139748222
          • E-mail: hyadav@usf.edu
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

Age 60 years and above; (ii) physician based clinically diagnosed MCI and the Montreal Cognitive Assessment (MoCA) score between 18 and 25; iii) LBP ≥ 30 μg/mL in plasma, and (iv) willing to sign informed consent, take intervention regimen, follow study team guidelines and donate sam-ples, as instructed by the study team; and (iv) live with a partner or care giver

Study partners in this study must meet the following inclusion criteria:

  • 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
  • Communicate effectively in English

Exclusion Criteria:

Brain and gut related surgery within the past 5 years that affected cognitive function: This information will be collected during the initial telephonic screening through an eligibility checklist. (ii) diagnosis of inflammatory bowel disease, ulcerative colitis, Crohn's disease, acid reflux, gastroesophageal reflux disease, Clostridium difficile infection, or any other gastrointestinal disease that might significantly change the microbiome, gut permeability, and inflammation: Participants will be asked about these diagnoses during the telephonic screening, and responses will be documented : Participants will be asked about these diagnoses during the telephonic screening, and responses will be documented. (iii) history of fecal microbiota transplantation and small intestinal bacterial growth: These conditions will also be screened via the initial eligibility questionnaire ad-ministered during the pre-screening phone interview. (iv) history of cancer or cancer treatment in past 5 years: Participants will be asked to report any history of cancer or treatment during the tele-phonic screening (v) nausea, vomiting, food poisoning, constipation, or diarrhea and/or antibiotic use in the past 30 days; These symptoms will be captured via a brief symptom checklist completed at the time of recruitment as well as on-site at the initial study visit. (vi) heavy consumption of pro-biotics, yogurt, or other fermented food (>4 servings per day): Questionnaire on probiotic yogurt, or other fermented food will be administered during the initial screening by telephonic talk as well as on-site visit to capture this information.(vii) critical or terminal illnesses; (viii) having neurological disorders like epilepsy, Parkinson's disease and Amyotrophic lateral sclerosis: These conditions will be assessed via direct questioning during the telephonic pre-screening interview (ix) pregnant or prisoner: Pregnancy status will be determined via verbal confirmation during screening and documented in the eligibility checklist. (x) unable to eat the test product according to the regulations; (xi) participating in other clinical trial; (xii) any diagnosis or condition that renders the subject ineligible at the discretion of the PI and/or the study team.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
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.
Inactive ingredients like maltodextrin; placebo capsules contain only inactive ingredients.
Outros nomes:
  • Grupo placebo
Comparador de Placebo: 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
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.
Inactive ingredients like maltodextrin; placebo capsules contain only inactive ingredients.
Outros nomes:
  • Grupo placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Plasma Lipopolysaccharide-Binding Protein (LBP) Level
Prazo: Baseline to Day 60
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.
Baseline to Day 60

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Stool Mucin Level
Prazo: Baseline to Day 60
Change in stool mucin level from baseline to Day 60. Stool mucin will be measured using an enzyme-linked immunosorbent assay (ELISA).
Baseline to Day 60
Change in Plasma C-Reactive Protein (CRP) Level
Prazo: Baseline to Day 60
Change in plasma C-reactive protein (CRP) concentration from baseline to Day 60 as a marker of systemic inflammation.
Baseline to Day 60
Change in Plasma Interleukin-6 (IL-6) Level
Prazo: Baseline to Day 60
Change in plasma interleukin-6 (IL-6) concentration from baseline to Day 60 as a marker of systemic inflammation.
Baseline to Day 60
Change in Plasma Tumor Necrosis Factor-Alpha (TNF-α) Level
Prazo: Baseline to Day 60
Change in plasma tumor necrosis factor-alpha (TNF-α) concentration from baseline to Day 60 as a marker of systemic inflammation.
Baseline to Day 60
Change in Plasma Interleukin-1 Beta (IL-1β) Level
Prazo: Baseline to Day 60
Change in plasma interleukin-1 beta (IL-1β) concentration from baseline to Day 60 as a marker of systemic inflammation.
Baseline to Day 60
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Prazo: Baseline to Day 60
Change from baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score. The CDR-SB evaluates six domains of cognitive and functional performance: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment; therefore, a lower score represents a better outcome.
Baseline to Day 60
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale 14 (ADAS-Cog14) Score
Prazo: Baseline to Day 60
Change from baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale 14 (ADAS-Cog14) score. The ADAS-Cog14 assesses cognitive domains including memory, attention, language, and executive function. The total score ranges from 0 to 90, with higher scores indicating greater cognitive impairment; therefore, a lower score represents a better outcome.
Baseline to Day 60
Change in Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score
Prazo: Baseline to Day 60
Change from baseline in the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) score. The ADCS-iADL assesses instrumental activities required for independent daily functioning. The score ranges from 0 to 56, with higher scores indicating better functional ability; therefore, a higher score represents a better outcome.
Baseline to Day 60

Colaboradores e Investigadores

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Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de março de 2026

Conclusão Primária (Estimado)

15 de novembro de 2026

Conclusão do estudo (Estimado)

15 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de agosto de 2026

Primeira postagem (Real)

31 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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