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

Abstract

Increasing 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.