Alzheimer DiseaseTREATNCT06199193
Design of Personalised SupplemenTs Based on the Gut MicRobiota Through Artificial Intelligence for Alzheimer's Patients
A study testing Personalized diet and Dietary counseling in people with Alzheimer Disease and Gut Microbiota, run by Universidad Complutense de Madrid at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Gut Microbiota
- What is being tested?
- Personalized diet and Dietary counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Feb 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
- 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
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Enrolling by invitation
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
Juan Marín Muñoz, MD, PhD, +34968 369 409, juan.marin5@carm.es
About this study
Official title: Design of Personalised SupplemenTs Based on the Gut MicRobiota of Alzheimer Patients Through Network and Artificial Intelligence Analysis
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.
Read the 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.
- Conditions
- Alzheimer Disease, Gut Microbiota
- Being tested
- Personalized diet, Dietary counseling
- Keywords
- Alzheimer's disease, Gut Microbiota, Physical exercise, Artificial intelligence, Supplementation
- Medical subject headings
- Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized dietDietary supplement
Personalized supplement designed by artificial intelligence based on the intestinal microbiota and incorporated into diets
Dietary counselingDietary supplement
Dietary advice will be provided to adapt the diet to the nutritional objectives and recommended intakes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Personalized diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota
- Differences in fecal microbiota between healthy controls and Alzheimer's disease participants
- Changes in fecal microbiota in Alzheimer's disease participants before and after a nutritional intervention.
Microbiota shotgun analysis
Measured: Baseline, an average of 1.5 years from baseline and change after three months
Secondary outcomes (6)
Dietary habits characterization
Diet characterization of healthy controls and Alzheimer's disease participants
- Changes in diet in Alzheimer's disease participants before and after a nutritional intervention
3-day registration questionnaire, a food consumption frequency questionnaire and adherence to mediterranean diet questionnaire will be used. Percentage of macronutrients ingested will be obtained.
Measured: Baseline, an average of 1.5 years from baseline and change after three months
Physical activity (PA) characterization
The International Physical Activity Questionnaire for Older People (IPAQ-E) quantifies subjects' activity in minutes per week and categorizes the results into Metabolic Equivalent of Task (MET) values. 1 MET is equivalent to 3.5 mL of oxygen consumed per kg per minute.
PA is characterized as:
Low: No PA is performed, or the activity is insufficient to reach moderate or high activity.
Moderate: Involves three or more days of vigorous PA for at least 25 minutes per day, or five or more days of vigorous PA and/or walking for at least 30 minutes per day. Additionally, achieving an energy expenditure of at least 600 METs per minute per week through a combination of activities.
High: Involves vigorous activity at least three days per week, resulting in an energy expenditure of 1500 METs per minute per week. Alternatively, seven or more days of a combination of walking, moderate, and/or vigorous activity, reaching an energy expenditure of at least 3000 METs per minute per week.
Measured: Baseline
Blood lipopolysaccharide (LPS)
Changes in LPS in healthy controls and Alzheimer's disease participants
- Changes in LPS in Alzheimer's disease participants before and after a nutritional intervention
To analyze circulating LPS levels in blood samples
Measured: Baseline, an average of 1.5 years from baseline and change after three months
Fecal Short chain fatty acids (SCFA)
Changes in fecal SCFA in healthy controls and Alzheimer's disease participants
- Changes in fecal SCFA in Alzheimer's disease participants before and after a nutritional intervention
SCFA will be analyzed by High performance liquid chromatography (HPLC)
Measured: Baseline, an average of 1.5 years from baseline and change after three months
Metabolomic analysis
Changes in serum and fecal samples in Alzheimer's disease participants before and after a nutritional intervention to search for potential markers of the supplement's effect on health.
Measured: An average of 1.5 years from baseline and change after three months
Bile fecal acids
- Changes in fecal bile acids in Alzheimer's disease participants before and after a nutritional intervention Bile fecal acids will be analyzed by High performance liquid chromatography (HPLC)
Measured: Baseline, an average of 1.5 years from baseline and change after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Feb 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Arrixaca, Universidad Europea de Madrid, Puerta de Hierro University Hospital
- Responsible party
- Sponsor
- Investigators
- Mar Larrosa, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199193
- Sponsor's protocol ID
- PID2021-123700OB-I00
- Acronym
- TREAT
- Status last verified
- Apr 2024
- First submitted
- 5 Dec 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41064285
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of Personalised SupplemenTs Based on the Gut MicRobiota of Alzheimer Patients Through Network and Artificial Intelligence Analysis
- ClinicalTrials.gov ID
- NCT06199193
- Acronym / sponsor ID
- TREAT / PID2021-123700OB-I00
- Conditions
- Alzheimer Disease, Gut Microbiota
- Keywords
- Alzheimer's disease, Gut Microbiota, Physical exercise, Artificial intelligence, Supplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Arrixaca, Universidad Europea de Madrid, Puerta de Hierro University Hospital
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Dietary counselingAlzheimer patients (60) will continue with their routine normal diet and samples will be collected. |
| Alzheimer patients with personalized diet | Experimental | Dietary Supplement: Personalized dietAlzheimer 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized dietPersonalized supplement designed by artificial intelligence based on the intestinal microbiota and incorporated into diets | Dietary supplement | Alzheimer patients with personalized diet |
| Dietary counselingDietary advice will be provided to adapt the diet to the nutritional objectives and recommended intakes. | Dietary supplement | Alzheimer patients with routine normal diet and dietary counseling |
Primary outcome
Fecal microbiota
Time frame: Baseline, an average of 1.5 years from baseline and change after three months
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
6 secondary outcomes
Dietary habits characterization
Time frame: Baseline, an average of 1.5 years from baseline and change after three months
Physical activity (PA) characterization
Time frame: Baseline
Blood lipopolysaccharide (LPS)
Time frame: Baseline, an average of 1.5 years from baseline and change after three months
Fecal Short chain fatty acids (SCFA)
Time frame: Baseline, an average of 1.5 years from baseline and change after three months
Metabolomic analysis
Time frame: An average of 1.5 years from baseline and change after three months
Bile fecal acids
Time frame: Baseline, an average of 1.5 years from baseline and change after three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 41064285Clemente-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mar Larrosa, PhD principal investigator
Universidad Complutense de Madrid
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized diet and Dietary counseling in people with Alzheimer Disease and Gut Microbiota, run by Universidad Complutense de Madrid at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mar Larrosa, PhD (+34913942041, mlarrosa@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbiota (time frame: Baseline, an average of 1.5 years from baseline and change after three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.