Clinical Trial to Evaluate the Efficacy of a Probiotic Formula on Cognitive Function in Mild Cognitive Impairement Patients.
Mild cognitive impairment is currently one of the most relevant social challenges, as its prevalence is expected to increase and it is associated with a higher risk of developing Alzheimer's disease or other types of dementia. Therefore, it is necessary to seek strategies that can be applied in the early stages to delay or reverse the progression of the disease. In this context, probiotics have emerged as a promising alternative for managing cognitive disorders. This project is a clinical-nutritional trial to evaluate the utility of consuming a dietary supplement containing probiotics on the cognitive function of individuals with mild cognitive impairment. The study will involve 100 participants, selected from the Geriatrics Unit of San Carlos Clinical Hospital, as well as through various Leisure Centers in Madrid, randomly assigned to two groups of 50 individuals each (Experimental Group and Control Group). Participants assigned to the experimental group will consume the dietary supplement, while those in the control group will receive a placebo, which is a product without probiotics. Both groups will take 1 capsule per day of the assigned product at breakfast for 16 weeks. During this time, changes will be analyzed in various imaging tests, cognitive tests, and some blood parameters related to cognitive function. Changes in gut microbiota and different lifestyle factors (diet, body composition, physical activity, sleep) will also be evaluated.
• Men and women aged between 60 and 85 years.
• Present Mild Cognitive Impairment (MCI) based on:
• MoCA test (\< 26 points) or score adjusted for educational level
• and CDR test (≤ 0.5 points)
• Maintain functional capacity according to the (I)ADL test (≥ 70 points)
• Show cognitive concern reported by the participant and/or a surrogate caregiver
• Demonstrate longitudinal decline in cognitive function (progressive and not stabilized) for more than 3-5 years.
• BMI ≥ 20 and \< 30 kg/m²
• Absence of a family or social environment that prevents treatment adherence.
• Adequate cultural level and understanding of the clinical study.
• Agree to participate voluntarily in the study and provide written informed consent.