Clinical trial NCT06199193: Design of Personalised SupplemenTs Based on the Gut MicRobiota Through Artificial Intelligence for Alzheimer's Patients
Official title: Design of Personalised SupplemenTs Based on the Gut MicRobiota of Alzheimer Patients Through Network and Artificial Intelligence Analysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Gut Microbiota
Keywords: Alzheimer's disease
Gut Microbiota
Physical exercise
Artificial intelligence
Supplementation
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen de la Arrixaca
name: Universidad Europea de Madrid
name: Puerta de Hierro University Hospital
First posted: 2024-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fecal microbiota
timeFrame: Baseline, an average of 1.5 years from baseline and change after three months
Secondary outcomes:
measure: Dietary habits characterization
timeFrame: Baseline, an average of 1.5 years from baseline and change after three months
measure: Physical activity (PA) characterization
timeFrame: Baseline
measure: Blood lipopolysaccharide (LPS)
timeFrame: Baseline, an average of 1.5 years from baseline and change after three months
measure: Fecal Short chain fatty acids (SCFA)
timeFrame: Baseline, an average of 1.5 years from baseline and change after three months
measure: Metabolomic analysis
timeFrame: An average of 1.5 years from baseline and change after three months
measure: Bile fecal acids
timeFrame: Baseline, an average of 1.5 years from baseline and change after three months
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
affiliation: Universidad Complutense de Madrid
name: Mar Larrosa, PhD
role: PRINCIPAL_INVESTIGATOR
References: