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

NCT06797817 | Not Yet Recruiting Phase 3

• 1 other identifier: 066160941-160941-4-824
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease (AD)

Keywords

butyrate; cognitive decline; cytokines; oxidative stress; gut microbiome; tributyrin; alzheimer disease

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  For cognitive evaluation, the Montreal Cognitive Assessment (MoCA) will be utilized, a widely recognized tool developed to identify mild cognitive impairment. In comparison to the Mini-Mental State Examination (MMSE), MoCA exhibits greater sensitivity, particularly in the early stages of AD, allowing for the detection of deficits in areas such as attention, memory, language, abstraction, and executive functions The MoCA is assessed on a scale ranging from 0 to 30, where higher scores reflect superior cognitive performance. A score of 26 or higher is typically regarded as within the normal range, whereas lower scores indicate different levels of cognitive impairment.

  Change from Baseline to 12 weeks and 24 weeks

Secondary Outcomes (20)

• 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

Study Arms (2)

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.

Dietary Supplement: tributyrin

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

Placebo OTHER

The placebo will consist of potato starch encapsulated under identical conditions to those used for the tributyrin capsules, ensuring adequate blinding of the study.

tributyrin DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Universidad de Almería

Almería, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

tributyrin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Pablo Roman, PhD

CONTACT

0034950214563; pablo.roman@ual.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The process of random assignment of participants will be carried out using opaque envelopes containing the assignment to the butyrate group (experimental group) and the CG group (control group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dean of the Faculty of Health Sciences

Model Details: A randomized clinical trial (1:1), parallel, and double-blind will be conducted. This study will adhere to the guidelines outlined by the CONsolidated Standards of Reporting Trials (CONSORT)

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 2, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)