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| Name | Class |
|---|---|
| Hospital Universitario Virgen de la Arrixaca | OTHER |
| Universidad Europea de Madrid | OTHER |
| Puerta de Hierro University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized diet | Dietary Supplement | Personalized supplement designed by artificial intelligence based on the intestinal microbiota and incorporated into diets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota |
Microbiota shotgun analysis | Baseline, an average of 1.5 years from baseline and change after three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mar Larrosa, PhD | Contact | +34913942041 | mlarrosa@ucm.es | |
| Juan Marín Muñoz, MD, PhD | Contact | +34968 369 409 | juan.marin5@carm.es |
| Name | Affiliation | Role |
|---|---|---|
| Mar Larrosa, PhD | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro | Enrolling by invitation | Majadahonda | Madrid | 28222 | Spain | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41064285 | Derived | 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. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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)
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| Dietary counseling | Dietary Supplement | Dietary advice will be provided to adapt the diet to the nutritional objectives and recommended intakes. |
|
| 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. | 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 | 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) | 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. | 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) | Baseline, an average of 1.5 years from baseline and change after three months |
| Hospital Clínico Universitario Virgen de la Arrixaca |
| Recruiting |
| Murcia |
| Murcia |
| 30120 |
| Spain |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |