Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyrate Effects Via the Gut-Brain
NCT ID: NCT06797817
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
156 participants
INTERVENTIONAL
2026-06-01
2029-09-02
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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. The administration of the placebo will follow the same protocol as that of the intervention group.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Universidad de Almeria
OTHER
Responsible Party
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Pablo Román López
Associate Professor, Dean of the Faculty of Health Sciences
Locations
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Universidad de Almería
Almería, , Spain
Countries
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Central Contacts
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Other Identifiers
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066160941-160941-4-824
Identifier Type: -
Identifier Source: org_study_id