Study protocol for design of a personalized dietary supplement based on the gut microbiota of Alzheimer’s patients and evaluation of its effects in a pilot randomized controlled trial

Clemente Velasco, SaraLucas Moreno, Beatriz deTabone, MariangelaBressa, CarloGonzález Soltero, María del RocíoMartín Lopez, SaraBailén, MaríaDomínguez Balmaseda, DiegoCastellanos, Nazareth P.Díez, Gustavo G.Et.al.2025-10-272025-10-272025Clemente‑Velasco, S., de Lucas, B., Tabone, M., Bressa, C., González‑Soltero, M. del R., Martínez‑López, S., Bailén, M., Domínguez‑Balmaseda, D., Castellanos, N., Diez, G. G., Noguera‑Perea, F., Marín‑Muñoz, J., Sánchez‑Alonso, P., Rey, A. I., Gálvez, B. G., & Larrosa, M. (2025). Study protocol for design of a personalized dietary supplement based on the gut microbiota of Alzheimer’s patients and evaluation of its effects in a pilot randomized controlled trial. Frontiers in Nutrition, 12, 1653841. https://doi.org/10.3389/fnut.2025.16538412296-861Xhttps://hdl.handle.net/11268/16417Increasing evidence links gut microbiota composition to neurological disorders, including Alzheimer’s disease (AD), through the gut-brain axis. Microbial metabolites such as lipopolysaccharide (LPS) and butyrate are associated with AD progression. Among modifiable factors, diet plays a central role in shaping gut microbiota and may influence disease-related microbial patterns. Personalized nutrition based on individual microbiota profiles offers a promising strategy to modulate these biomarkers. This protocol describes a study designed to develop a personalized dietary supplement for patients with AD by integrating microbiota, clinical, and dietary data using artificial intelligence (AI) and network analysis. A secondary objective is to assess in a pilot study the short-term effects of the supplement on microbiota composition, function, and plasma metabolomics to identify modifiable biomarkers.engAttribution 4.0 Internationalhttps://creativecommons.org/licenses/by/4.0/Microbioma GastrointestinalEnfermedad de AlzheimerEstudio pilotoStudy protocol for design of a personalized dietary supplement based on the gut microbiota of Alzheimer’s patients and evaluation of its effects in a pilot randomized controlled trialjournal article10.3389/fnut.2025.1653841open accessEnfermedad nutricionalInteligencia artificialInvestigación médicaGoal 3: Ensure healthy lives and promote well-being for all at all ages