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

Last updated: December 4, 2024
Sponsor: Universidad Complutense de Madrid
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Dietary counseling

Personalized diet

Clinical Study ID

NCT06199193
PID2021-123700OB-I00
  • Ages 60-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. to be able to give written consent signed jointly by the patient's legalrepresentative 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 auditoryacuity, in the opinion of the researcher, to enable him/her to carry out the testsin the study (compensatory glasses and hearing aids are allowed

  4. compliance with the diagnostic criteria of prodromal Alzheimer's Disease accordingto the criteria of the Institute on Aging- Alzheimer's Association [NIA-AA]: GlobalDeterioration Scale GDS≥ 2-3

  5. Availability of a person ('caregiver') who has frequent and sufficient contact withthe subject, so that he/she can provide precise information on the subject'sday-to-day life, and attend the visits that are required by the study

Exclusion

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 andfunctionality

  2. Metabolic/endocrine disorders: Type I diabetes, the rest will not be excluded

  3. Chronic or sporadic use of antibiotics, antifungals, antivirals or anti-parasiticagents and chronic use of proton pump inhibitors (omeprazole, etc.). The chronicmedication that these patients take due to hypertension, diabetes, etc., should berecorded in the database but should not be a criterion for exclusion

  4. Suffer from some type of pathology related to the gastrointestinal system or haveundergone gastrointestinal surgery (ulcerative colitis, Crohn's disease, bariatricsurgery)

  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.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Dietary counseling
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

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