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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Personalized supplement designed by artificial intelligence based on the intestinal microbiota and incorporated into diets
Dietary advice will be provided to adapt the diet to the nutritional objectives and recommended intakes.
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
ENROLLING_BY_INVITATIONHospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain
RECRUITINGFecal 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
Time frame: Baseline, an average of 1.5 years from baseline and change after three months
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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: Baseline, an average of 1.5 years from baseline and change after three months
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