NCT06199193

Design of Personalised SupplemenTs Based on the Gut MicRobiota Through Artificial Intelligence for Alzheimer's Patients

Design of Personalised SupplemenTs Based on the Gut MicRobiota of Alzheimer Patients Through Network and Artificial Intelligence Analysis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Studies indicate that the intestinal microbiota could have an implication in Alzheimer's disease; recently, a positive relationship has been established between levels of bacterial lipopolysaccharide (LPS) and cerebral amyloidosis and a negative relationship between the production of the chain fatty acid cuts butyrate by the intestinal microbiota and cerebral amyloidosis. Currently there is no effective treatment for Alzheimer's, but studies indicate that a healthy diet such as the Mediterranean diet and physical exercise delay the symptoms of this disease. For all these reasons, it is postulated that introducing changes in the intestinal microbiota through diet may be a new treatment or serve as an adjuvant treatment for Alzheimer's disease.

Detailed description

The study consists of three main stages, a first part in which healthy subjects and patients will be characterized. With all the variables obtained, network analyzes and predictive analyzes are carried out in order to see the interaction between variables and determine predictive variables of Alzheimer's disease that could be subject to modification by the diet. In a second stage, the personalized supplement will be designed based on the characteristics of Alzheimer's patients and there is no patient participation. In a third stage, a randomized, parallel nutritional intervention trial will be carried out where the supplement designed "ad hoc" will be compared in the population of Alzheimer's patients against a nutritional supplement commonly used in Alzheimer's patients.

Conditions

• Alzheimer Disease
• Gut Microbiota

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Personalized diet	Personalized supplement designed by artificial intelligence based on the intestinal microbiota and incorporated into diets
DIETARY_SUPPLEMENT	Dietary counseling	Dietary advice will be provided to adapt the diet to the nutritional objectives and recommended intakes.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-04-01
• Completion: 2025-12-31
• First posted: 2024-01-10
• Last updated: 2024-12-09

Locations

2 sites across 1 country: Spain