An interventional study of Personalized diet and Dietary counseling in Alzheimer Disease and Gut Microbiota, sponsored by Universidad Complutense de Madrid. Recruiting at 2 sites in Spain. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Control human patients (60),non suffering from Alzheimer, will continue with their normal dietary habits and samples will be collected.
Alzheimer patients (60) will continue with their routine normal diet and samples will be collected.
Dietary Supplement: Dietary counseling
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
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.
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
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
Plan to share: No
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Universidad Complutense de Madrid