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RECRUITING

NCT06199193

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

Sponsor: Universidad Complutense de Madrid

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

60 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-02-01

Completion Date

2025-12-31

Last Updated

2024-12-09

Healthy Volunteers

Yes

Conditions

Alzheimer Disease Gut Microbiota

Interventions

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.

Inclusion Criteria: 1. to be able to give written consent signed jointly by the patient's legal representative following the rules of the clinical research ethics committee 2. minimum educational level (reading and writing) 3. proficiency of the language of the tests applied; adequate visual and auditory acuity, in the opinion of the researcher, to enable him/her to carry out the tests in the study (compensatory glasses and hearing aids are allowed 4. compliance with the diagnostic criteria of prodromal Alzheimer's Disease according to the criteria of the Institute on Aging- Alzheimer's Association \[NIA-AA\]: Global Deterioration Scale GDS≥ 2-3 5. Availability of a person ('caregiver') who has frequent and sufficient contact with the subject, so that he/she can provide precise information on the subject's day-to-day life, and attend the visits that are required by the study Exclusion Criteria: 1. Suffer or have suffered from neurological (epilepsy, sleep disorders, etc.), psychiatric or any other type of pathology (sensory, hepatic, infectious, etc.) which, in the investigator's opinion, may affect their current cognition and functionality 2. Metabolic/endocrine disorders: Type I diabetes, the rest will not be excluded 3. Chronic or sporadic use of antibiotics, antifungals, antivirals or anti-parasitic agents and chronic use of proton pump inhibitors (omeprazole, etc.). The chronic medication that these patients take due to hypertension, diabetes, etc., should be recorded in the database but should not be a criterion for exclusion 4. Suffer from some type of pathology related to the gastrointestinal system or have undergone gastrointestinal surgery (ulcerative colitis, Crohn's disease, bariatric surgery) 5. Pre-menopause or perimenopause Control patients: recruited among the relatives and companions of the patients and/or in primary care centers in the region of Murcia. The inclusion criteria for the control group will be the same as for the Alzheimer's group except for the requirements regarding cognitive impairment. The intention is for the control group to be similar in age and sex distribution to the Alzheimer's group.

Locations (2)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain