Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyrate Effects Via the Gut-Brain

Overview

The goal of this clinical trial is to learn if tributyrin can help prevent or mitigate cognitive decline in individuals with mild Alzheimer's disease (AD). The trial will also examine the safety and effects of tributyrin on inflammation and gut microbiota. The main questions it aims to answer are: Does tributyrin reduce inflammation and neurodegeneration markers? How does tributyrin affect gut microbiota and intestinal permeability? Researchers will compare tributyrin to a placebo (a look-alike substance that contains no active ingredient) to evaluate its effectiveness. Participants will: Take tributyrin or a placebo every day for 12 weeks. Undergo assessments of cognitive function, blood markers (such as NfL and pTau217), and gut health. The findings are expected to provide insight into the potential of tributyrin as a preventive intervention for Alzheimer's disease.

Interventions

• Dietary supplement tributyrin
  Participants will receive 1 capsule per day for 12 weeks. Each capsule contains 450 mg of tributyrins. The capsules will have a gelatin coating. In the market, formulations are available with dosages ranging from 200 to 500 mg.
• Other Placebo
  The placebo will consist of potato starch encapsulated under identical conditions to those used for the tributyrin capsules, ensuring adequate blinding of the study.

Primary outcome measures

• Montreal Cognitive Assessment (MoCA) [Time frame: Change from Baseline to 12 weeks and 24 weeks]

Secondary outcome measures (12)

• Levels of SCFAs (Acetate, Propionate and Butyrate) in faeces [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Intestinal permeability [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Systemic inflammation [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Serum levels of NfL [Time frame: Change from baseline to 12 weeks and 24 weeks]
• Serum levels of pTau217 [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Serum levels of Amyloid42/40 ratio [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Composition of Intestinal Microbiota (16S rRNA Gene Sequencing) [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Accuracy in N-back Task (Working Memory) [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Reaction Time in N-back Task (Working Memory) [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Verbal memory by Rey Test [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Visual memory by Rey Test [Time frame: Change from Baseline to 12 weeks and 24 weeks]
• Sustained attention by CPT [Time frame: Change from baseline to 12 weeks and 24 weeks]

Eligibility criteria

Inclusion criteria

• individuals diagnosed with mild AD within the past year (ICD-10: F00.1).
• voluntary consent to participate in the study in accordance with the Declaration of Helsinki.
• not currently enrolled in any other clinical trial that could confound the results.

Exclusion criteria

• individuals with other potential causes of dementia, such as a history of severe traumatic brain injury, brain tumours, epilepsy, or central nervous system infections.
• individuals involved in an intervention that interferes with the trial (immunosuppressive drugs, steroids, antibiotics, or received chemotherapy in the month prior to the start of the intervention).
• individuals with gastrointestinal disorders.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Universidad de Almería — Almería

Identifiers

NCT: NCT06797817 · 066160941-160941-4-824

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗