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

NCT06199193 | Recruiting DMC

• 1 other identifier: PID2021-123700OB-I00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alzheimer Disease; Gut Microbiota

Keywords

Alzheimer's disease; Gut Microbiota; Physical exercise; Artificial intelligence; Supplementation

Outcome Measures

Primary Outcomes (1)

• Fecal microbiota

  1. Differences in fecal microbiota between healthy controls and Alzheimer's disease participants 2. Changes in fecal microbiota in Alzheimer's disease participants before and after a nutritional intervention. Microbiota shotgun analysis

  Baseline, an average of 1.5 years from baseline and change after three months

Secondary Outcomes (6)

• Dietary habits characterization

  Baseline, an average of 1.5 years from baseline and change after three months

• Physical activity (PA) characterization

  Baseline

• Blood lipopolysaccharide (LPS)

  Baseline, an average of 1.5 years from baseline and change after three months

• Fecal Short chain fatty acids (SCFA)

  Baseline, an average of 1.5 years from baseline and change after three months

• Metabolomic analysis

  An average of 1.5 years from baseline and change after three months

Study Arms (3)

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

NO INTERVENTION

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

Alzheimer patients with routine normal diet and dietary counseling

SHAM COMPARATOR

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

Dietary Supplement: Dietary counseling

Alzheimer patients with personalized diet

EXPERIMENTAL

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.

Dietary Supplement: Personalized diet

Interventions

Personalized diet DIETARY_SUPPLEMENT

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

Alzheimer patients with personalized diet

Dietary counseling DIETARY_SUPPLEMENT

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

Alzheimer patients with routine normal diet and dietary counseling

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to be able to give written consent signed jointly by the patient's legal representative following the rules of the clinical research ethics committee
• minimum educational level (reading and writing)
• 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
• 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
• 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

You may not qualify if:

• 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
• Metabolic/endocrine disorders: Type I diabetes, the rest will not be excluded
• Suffer from some type of pathology related to the gastrointestinal system or have undergone gastrointestinal surgery (ulcerative colitis, Crohn's disease, bariatric surgery)
• Pre-menopause or perimenopause

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Hospital Universitario Virgen de la Arrixaca: collaborator
• Universidad Europea de Madrid: collaborator
• Puerta de Hierro University Hospital: collaborator

Study Sites (2)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

ENROLLING BY INVITATION

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 41064285 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Mar Larrosa, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mar Larrosa, PhD

CONTACT

+34913942041; mlarrosa@ucm.es

Juan Marín Muñoz, MD, PhD

CONTACT

+34968 369 409; juan.marin5@carm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 10, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)