Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyric Acid Effects Via the Gut-Brain (TRIM-GUT)

Universidad de Almeria

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Alzheimer Disease (AD)

Treatments: Dietary Supplement: tributyrin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06797817

066160941-160941-4-824

Details and patient eligibility

About

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 improve cognitive function in patients with mild AD? Does tributyrin reduce inflammation and oxidative stress? 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 BDNF and GFAP), and gut health.

The findings are expected to provide insight into the potential of tributyrin as a preventive intervention for Alzheimer's disease.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups, including a placebo group

Tributyrin

Experimental group

Description:

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.

Treatment:

Dietary Supplement: tributyrin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo