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

NCT ID: NCT06199193

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Alzheimer Disease Gut Microbiota

Keywords

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Alzheimer's disease Gut Microbiota Physical exercise Artificial intelligence Supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: Control healthy humans with normal diet (n=30) Group 2: Alzheimer patients with normal diet (n=30). Group 3: Alzheimer patients with designed supplements(n=30)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Human patient (non-Alzheimer) with routine normal diet

Control human patients (60),non suffering from Alzheimer, will continue with their normal dietary habits and samples will be collected.

Group Type NO_INTERVENTION

No interventions assigned to this group

Alzheimer patients with routine normal diet and dietary counseling

Alzheimer patients (60) will continue with their routine normal diet and samples will be collected.

Group Type SHAM_COMPARATOR

Dietary counseling

Intervention Type DIETARY_SUPPLEMENT

Dietary advice will be provided to adapt the diet to the nutritional objectives and recommended intakes.

Alzheimer patients with personalized diet

Alzheimer patients (30) will be given personalized diet, with supplements based on the gut microbiota (elaborated through AI analyses) or a standard supplement (n=30) Samples will be collected.

Group Type EXPERIMENTAL

Personalized diet

Intervention Type DIETARY_SUPPLEMENT

Personalized supplement designed by artificial intelligence based on the intestinal microbiota and incorporated into diets

Interventions

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Personalized diet

Personalized supplement designed by artificial intelligence based on the intestinal microbiota and incorporated into diets

Intervention Type DIETARY_SUPPLEMENT

Dietary counseling

Dietary advice will be provided to adapt the diet to the nutritional objectives and recommended intakes.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role collaborator

Universidad Europea de Madrid

OTHER

Sponsor Role collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mar Larrosa, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

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Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status ENROLLING_BY_INVITATION

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Mar Larrosa, PhD

Role: CONTACT

Phone: +34913942041

Email: [email protected]

Juan Marín Muñoz, MD, PhD

Role: CONTACT

Phone: +34968 369 409

Email: [email protected]

Facility Contacts

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Juan Marín Muñoz, MD, PhD

Role: primary

References

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Clemente-Velasco S, de Lucas B, Tabone M, Bressa C, Gonzalez-Soltero MDR, Martinez-Lopez S, Bailen M, Dominguez-Balmaseda D, Castellanos N, Diez GG, Noguera-Perea F, Marin-Munoz J, Sanchez-Alonso P, Rey AI, Galvez BG, Larrosa M. 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. Front Nutr. 2025 Sep 23;12:1653841. doi: 10.3389/fnut.2025.1653841. eCollection 2025.

Reference Type DERIVED
PMID: 41064285 (View on PubMed)

Other Identifiers

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PID2021-123700OB-I00

Identifier Type: -

Identifier Source: org_study_id