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

Official Summary

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.

Eligibility Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 156 participants

Study Arms

• Tributyrin (EXPERIMENTAL)
  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.
• Placebo (PLACEBO_COMPARATOR)
  The placebo will consist of potato starch encapsulated under identical conditions to those used for the tributyrin capsules, ensuring adequate blinding of the study. The administration of the placebo will follow the same protocol as that of the intervention group.

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 Outcomes

• Montreal Cognitive Assessment (MoCA) (Change from Baseline to 12 weeks and 24 weeks)

Secondary Outcomes

• Levels of SCFAs (Acetate, Propionate and Butyrate) in faeces (Change from Baseline to 12 weeks and 24 weeks)
• Intestinal permeability (Change from Baseline to 12 weeks and 24 weeks)
• Systemic inflammation (Change from Baseline to 12 weeks and 24 weeks)
• Serum levels of NfL (Change from baseline to 12 weeks and 24 weeks)
• Serum levels of pTau217 (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.

Trial Locations

• Universidad de Almería, Almería, Spain

Contact Information

• Pablo Roman, PhD — CONTACT
  Phone: 0034950214563
  Email: pablo.roman@ual.es

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